(12) United States Patent (10) Patent No.: US 9,707,229 B2 Ray, II (45) Date of Patent: *Jul.18, 2017

USOO9707229B2

(54) COMPOSITIONS AND METHODS FOR (56) References Cited TREATING AN INFECTION U.S. PATENT DOCUMENTS (71) Applicant: CMPD LICENSING, LLC, Conroe, 2009 OO16990 A1* 1/2009 Alberte ...... A61K 31,185 424,855 TX (US) 2014/0256826 A1* 9, 2014 Lemire ...... AON 31/08 514,703 (72) Inventor: Jay Richard Ray, II, Conroe, TX (US) OTHER PUBLICATIONS (73) Assignee: CMPD LICENSING, LLC, Conroe, PCCA Science, “Technical Report: The Antimicrobial Activity of TX (US) Itraconazole and LoxaSperse TM Against Biofilms of C. albicans.” 2013, www.ccarx.com, pp. 1-2.* U.S. Appl. No. 14/819,342, filed Aug. 5, 2015, Applicant is CMPD (*) Notice: Subject to any disclaimer, the term of this Licensing, LLC, Inventor is Jay Richard Ray, II. patent is extended or adjusted under 35 Label for Diflucan (Fluconazole Tablets), Distributed by Roerig, a U.S.C. 154(b) by 0 days. Division of Pfizer, Mar. 2013 (35 pages). Label (Package Insert) for Azithromycin, Distributed by SICOR This patent is Subject to a terminal dis Pharmaceuticals, Inc., Dec. 2016 (18 pages). claimer. Label for Bactroban (mupirocin), Distributed by GlaxoSmithKline, Dec. 2015 (10 pages). FDA Prescribing Information for Nystatin Powder, Distributed by (21) Appl. No.: 14/975,172 Mayne Pharma, Summarized by www.drugs.com (5 pages). PCCA, Brochure for LoxaSperse, "Powder Excipient Base for Use in Nebulization and Irrigation Compounds', 2013 (3 pages). (22) Filed: Dec. 18, 2015 PCCA, “New, Exclusive PCCA Base, XyliFosTM: Boost the LoxaSperseTM Power in Nasal Nebulization and Decrease your Cost', Aug. 7, 2015 (2 pages). (65) Prior Publication Data US 2017/O173OO3 A1 Jun. 22, 2017 * cited by examiner Primary Examiner — Sreeni Padmanabhan Assistant Examiner — Jody Karol (51) Int. C. A6 IK 3/496 (2006.01) (74) Attorney, Agent, or Firm — Akerman LLP A6 IK3I/35 (2006.01) (57) ABSTRACT A6 IK 45/06 (2006.01) The present application relates to compounded composi A6 IK 47/26 (2006.01) tions, methods of making compounded compositions, kits A6 IK 47/34 (2017.01) comprising compounded compositions, containers compris A6 IK 9/00 (2006.01) ing compounded compositions, and methods of using com A6H 35/00 (2006.01) pounded compositions. The present application also relates to anti-infective agents and methods of using anti-infective (52) U.S. C. agents. For example, disclosed herein are compounded CPC ...... A61K 31/496 (2013.01); A61H 35/006 compositions comprising an anti-bacterial agent, an anti (2013.01); A61K 9/0014 (2013.01); A61 K fungal agent, and an excipient base and methods of using a 3 1/351 (2013.01); A61K 45/06 (2013.01); compounded composition to treat or prevent a bacterial A61K 47/26 (2013.01); A61K 47/34 (2013.01) infection, a fungal infection, or both, or a Suspected bacterial (58) Field of Classification Search infection, a Suspected fungal infection, or both. This abstract CPC ...... A61K 31/496; A61K 31/351; A61 K is intended as a scanning tool for purposes of searching in 2300/00; A61K 45/06; A61 K9/0014: the particular art and is not intended to be limiting of the A61K 47/26: A61K 47/34: A61H 35/006 present invention. See application file for complete search history. 10 Claims, No Drawings US 9,707,229 B2 1. 2 COMPOSITIONS AND METHODS FOR itching, burning, cracking, Scaling, Swelling, and occasion TREATING AN INFECTION ally bleeding. Athlete's foot includes toe web infections, moccasin type infections, and vesicular type infections. The FIELD OF THE INVENTION condition generally includes Small vesicles, fissures, Scaling, maceration, hyperkeratinization, and eroded areas between The present application relates to compounded composi the toes and on the plantar Surface of the foot, as well as on tions, methods of making compounded compositions, and other skin areas. For example, the nails may show thicken methods of using compounded compositions to treat or ing, pitting, and Subungal debris. prevent an infection. The present application also relates to Reoccurrences of the infection are frequent. For some anti-infective agents and methods of using anti-infective 10 Subjects, such as those also diagnosed with diabetes or agents to treat or prevent an infection. circulatory problems, or obese subjects, tinea infections and BACKGROUND OF THE INVENTION their treatment can be quite serious. The source of the affliction often is a public safety and health concern, as the The body normally serves as host for a variety of bacteria 15 occurrence of tinea pedis is higher in public areas such as and fungi. Most of the time, the balance between the body locker rooms, public showers, sports facilities, and the like. as host and the microorganisms is maintained. However, Moreover, there are at least 3 different types of nail there are times when the physiological, biochemical, and/or infections caused by fungi. The most common infection is environmental conditions permit the microorganisms to tip frequently caused by Trichophyton rubrum and affects the that balance, thereby causing an infection. 2O nail bed and the area beneath the nail. Another type of Foot infections can be difficult problems for physicians to infection affects only the nail surface and creates white or treat because of the biomechanical complexities of the light colored patches. This second type of fungal infection is extremity and the underlying circumstances that cause the unusual and represents only about 10% of the reported cases. infections. Soft tissue infections in the foot consist of any A third type of fungal infection affects the nail root and infectious process affecting the skin, Subcutaneous tissue, 25 usually afflicts persons with impaired immune defense. A adipose tissue, Superficial or deep fascia, ligaments, tendons, fourth (and unusual) type is caused by an infection of yeast tendon sheaths, joints, and/or joint capsules. Considering fungi. Infections by yeast most often only affect nails that that there are more than 20 joints, 44 tendons, approximately already are infected or damaged in some way. 100 ligaments, 4 major compartments, and numerous fascial The fungi are invasive to the keratin nail tissue. Apart planes in the normal foot, the potential for complex prob- 30 from becoming discolored and brittle, the nail may often lems is high. separate from the nail bed. In addition, pain and difficulty in Bacterial infections of the feet can occur as collections of wearing foot apparel is often experienced. Initially, the pus, such as an abscess following a puncture wound or an disease affects only one nail, typically one nail of the foot, infected hair follicle. These types of infections are usually and is thereafter spread to more nails. The palms of the red and elevated, and sometimes can be mistaken for an 35 hands and the soles of the feet may frequently be affected as insect bite. There are many types of bacteria that cause an well. When the skin is affected, red spots frequently occur abscess, but staph are a leading cause. Bacterial skin infec and the skin may peel off. Nail fungal infections are one of tions can also resemble a rash, appearing as a reddened, the hardest forms of external infection to treat, of which tender, and warm area of skin. This type of infection is called infections of toe nails are the most difficult to treat. cellulitis and can spread quickly, leading to red streaks that 40 Despite advances in the understanding of the pathology of move from the foot toward the leg. The appearance of bacterial infections and fungal infections, there is still a need streaks is known as lymphangitis, which means the infection for compositions and methods that efficiently treat or pre is spreading toward the lymph nodes. Cellulitis and lymp vent the progression and reoccurrence of bacterial infections hangitis can be caused by a variety of types of bacteria, but and/or fungal infections that affect at least part of one or both staph and sometimes streptococcus are the most common 45 feet. causes. Any infection, especially cellulitis and lymphangitis, requires prompt medical attention to avoid further spreading BRIEF SUMMARY OF THE INVENTION and complications. If left untreated, then some infections can spread to deeper tissues, including bone. Disclosed herein is a compounded composition for treat Certain fungal infections of the skin known as tinea 50 ing an infection. infections are caused by dermatophytes, which are members Disclosed herein can be a compounded composition com of the Trichophyton, Microsporum, and Epidermophyton prising an anti-bacterial agent, an anti-fungal agent, and an species. These mold-like fungi thrive in warm, moist areas, excipient base powder comprising a blend of micronized thriving on the dead tissues of hair, nails, and outer skin Xylitol and poloxamers. layers. Tinea infections include tinea pedis, known as ath- 55 Disclosed herein is a compounded composition compris lete's foot; tinea corporis, known as ringworm, tinea capitis, ing mupirocin, an anti-fungal agent, and an excipient base a fungal infection of the Scalp that can cause hair loss; tinea powder comprising a blend of micronized Xylitol and poloX cruris, known as jock itch or tinea of the groin, tinea aS. ungulum, which is tinea of the nails; and tinea versicolor, a Disclosed herein is a compounded composition compris Superficial fungal infection that produces brown, tan, or 60 ing an anti-bacterial agent, itraconazole, and an excipient white spots on the trunk of the body. Tinea infections are base powder comprising a blend of micronized Xylitol and contagious and can be passed through direct contact or by poloxamers. contact with clothing, from shower and pool Surfaces, and Disclosed herein is a compounded composition compris even from pets. ing mupirocin, itraconazole, and an excipient base powder Athlete's foot or tinea pedis is by far the most common 65 comprising a blend of micronized Xylitol and poloxamers. form, with more than 12 million people in the United States Disclosed herein is a compounded composition compris Suffering from the disease per year. It presents with redness, ing mupirocin, itraconazole, an excipient base powder com US 9,707,229 B2 3 4 prising a blend of micronized Xylitol and poloxamers, and at Disclosed herein is a capsule comprising a compounded least one additional anti-infective agent. composition comprising an anti-bacterial agent, fluconazole, Disclosed herein is a compounded composition compris and an excipient base powder comprising a blend of micron ing azithromycin, an anti-fungal agent, and an excipient base ized Xylitol and poloxamers. powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a capsule comprising a compounded aS. composition comprising azithromycin, fluconazole, and an Disclosed herein is a compounded composition compris excipient base powder comprising a blend of micronized ing an anti-bacterial agent, fluconazole, and an excipient Xylitol and poloxamers. base powder comprising a blend of micronized Xylitol and Disclosed herein is a capsule comprising a compounded poloxamers. 10 composition comprising azithromycin, fluconazole, an Disclosed herein is a compounded composition compris excipient base powder comprising a blend of micronized ing azithromycin, fluconazole, and an excipient base powder Xylitol and poloxamers, and at least one additional anti comprising a blend of micronized Xylitol and poloxamers. infective agent. Disclosed herein is a compounded composition compris Disclosed herein is a capsule comprising a compounded ing azithromycin, fluconazole, an excipient base powder 15 composition comprising azithromycin, fluconazole, and comprising a blend of micronized Xylitol and poloxamers, LoxasperseTM excipient base powder. and at least one additional anti-infective agent. Disclosed herein is a capsule comprising a compounded Disclosed herein can be a compounded composition com composition, wherein the compounded composition com prising mupirocin, nystatin, and an excipient base powder prises mupirocin and nystatin. comprising a blend of micronized Xylitol and poloxamers. Disclosed herein is a capsule comprising a compounded Disclosed herein is a capsule comprising a disclosed composition comprising mupirocin, an anti-fungal agent, compounded composition. and an excipient base powder comprising a blend of micron Disclosed herein is a capsule comprising a compounded ized Xylitol and poloxamers. composition, wherein the compounded composition com 25 Disclosed herein is a capsule comprising a compounded prises an anti-bacterial agent and an anti-fungal agent. composition comprising an anti-bacterial agent, nystatin, Disclosed herein is a capsule comprising a compounded and an excipient base powder comprising a blend of micron composition, wherein the compounded composition com ized Xylitol and poloxamers. prises an anti-bacterial agent, an anti-fungal agent, and Disclosed herein is a capsule comprising a compounded LoxasperseTM excipient base powder. 30 composition comprising mupirocin, nystatin, and an excipi ent base powder comprising a blend of micronized Xylitol Disclosed herein is a capsule comprising a compounded and poloxamers. composition, wherein the compounded composition com Disclosed herein is a capsule comprising a compounded prises an anti-bacterial agent, an anti-fungal agent, and an composition comprising mupirocin, nystatin, an excipient excipient base powder comprising a blend of micronized 35 base powder comprising a blend of micronized Xylitol and Xylitol and poloxamers. poloxamers, and at least one additional anti-infective agent. Disclosed herein is a capsule comprising a compounded Disclosed herein is a capsule comprising a compounded composition, wherein the compounded composition com composition comprising mupirocin, nystatin, and Loxas prises mupirocin and itraconazole. perseTM excipient base powder. Disclosed herein is a capsule comprising a compounded 40 Disclosed herein is a capsule comprising an anti-bacterial composition comprising mupirocin, an anti-fungal agent, agent. Disclosed herein is a capsule comprising mupirocin. and an excipient base powder comprising a blend of micron Disclosed herein is a capsule comprising azithromycin. ized Xylitol and poloxamers. Disclosed herein is a capsule comprising an anti-fungal Disclosed herein is a capsule comprising a compounded agent. Disclosed herein is a capsule comprising itraconazole. composition comprising an anti-bacterial agent, itracon 45 Disclosed herein is a capsule comprising fluconazole. Dis azole, and an excipient base powder comprising a blend of closed herein is a capsule comprising nyStatin. micronized Xylitol and poloxamers. Disclosed herein is a container comprising a disclosed Disclosed herein is a capsule comprising a compounded compounded composition. composition comprising mupirocin, itraconazole, and an Disclosed herein is a container comprising a compounded excipient base powder comprising a blend of micronized 50 composition, wherein the compounded composition can Xylitol and poloxamers. comprise an anti-bacterial agent, an anti-fungal agent, and an excipient base powder comprising a blend of micronized Disclosed herein is a capsule comprising a compounded Xylitol and poloxamers. composition comprising mupirocin, itraconazole, an excipi Disclosed herein is a container comprising one or more ent base powder comprising a blend of micronized Xylitol 55 capsules, each capsule comprising a compounded composi and poloxamers, and at least one additional anti-infective tion, wherein the compounded composition can comprise an agent. anti-bacterial agent, an anti-fungal agent, and an excipient Disclosed herein is a capsule comprising a compounded base powder comprising a blend of micronized Xylitol and composition comprising mupirocin, itraconazole, and LOX poloxamers. asperseTM excipient base powder. 60 Disclosed herein is a container comprising a compounded Disclosed herein is a capsule comprising a compounded composition, wherein the compounded composition can composition, wherein the compounded composition com comprise mupirocin, itraconazole, and an excipient base prises azithromycin and fluconazole. powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a capsule comprising a compounded aS. composition comprising azithromycin, an anti-fungal agent, 65 Disclosed herein is a container comprising one or more and an excipient base powder comprising a blend of micron capsules, each capsule comprising a compounded composi ized Xylitol and poloxamers. tion, wherein the compounded composition can comprise US 9,707,229 B2 5 6 mupirocin, itraconazole, and an excipient base powder com Disclosed herein is a container comprising an anti-bacte prising a blend of micronized Xylitol and poloxamers. rial agent. Disclosed herein is a container comprising an Disclosed herein is a container comprising a compounded anti-fungal agent. composition, wherein the compounded composition can Disclosed herein is a kit comprising a disclosed compo comprise an anti-bacterial agent, itraconazole, and an excipi sition. ent base powder comprising a blend of micronized Xylitol Disclosed herein is a kit, comprising: one or more con and poloxamers. tainers, each comprising a compounded composition, Disclosed herein is a container comprising a compounded wherein the compounded composition can comprise a thera composition, wherein the compounded composition can peutically effective amount of an anti-bacterial agent, a comprise mupirocin, an anti-fungal agent, and an excipient 10 therapeutically effective amount of an anti-fungal agent, and base powder comprising a blend of micronized Xylitol and an amount of an excipient base powder comprising a blend poloxamers. of micronized Xylitol and poloxamers. Disclosed herein is a container comprising a compounded Disclosed herein is a kit, comprising: one or more con composition, wherein the compounded composition can tainers, each comprising a compounded composition, comprise mupirocin, itraconazole, an excipient base powder 15 wherein the compounded composition can comprise a thera comprising a blend of micronized Xylitol and poloxamers, peutically effective amount of an anti-bacterial agent, a and at least one additional anti-infective agent. therapeutically effective amount of an anti-fungal agent, and Disclosed herein is a container comprising a compounded an excipient base powder comprising a blend of micronized composition, wherein the compounded composition can Xylitol and poloxamers, and instructions for using the com comprise azithromycin, fluconazole, and an excipient base pounded composition. powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a kit, comprising: one or more con aS. tainers, each comprising a compounded composition, Disclosed herein is a container comprising one or more wherein the compounded composition can comprise a thera capsules, each capsule comprising a compounded composi 25 peutically effective amount of an anti-bacterial agent, a tion, wherein the compounded composition can comprise therapeutically effective amount of an anti-fungal agent, and azithromycin, fluconazole, and an excipient base powder an excipient base powder comprising a blend of micronized comprising a blend of micronized Xylitol and poloxamers. Xylitol and poloxamers, a foot bath, and instructions for Disclosed herein is a container comprising a compounded using the compounded composition. composition, wherein the compounded composition can 30 Disclosed herein is a kit, comprising: one or more con comprise an anti-bacterial agent, fluconazole, and an excipi tainers, each comprising a compounded composition, ent base powder comprising a blend of micronized xylitol wherein the compounded composition can comprise athera and poloxamers. peutically effective amount of mupirocin, a therapeutically Disclosed herein is a container comprising a compounded effective amount of itraconazole, and an excipient base composition, wherein the compounded composition can 35 powder comprising a blend of micronized Xylitol and poloX comprise azithromycin, an anti-fungal agent, and an excipi aS. ent base powder comprising a blend of micronized Xylitol Disclosed herein is a kit, comprising: one or more con and poloxamers. tainers, each comprising a compounded composition, Disclosed herein is a container comprising a compounded wherein the compounded composition can comprise a thera composition, wherein the compounded composition can 40 peutically effective amount of mupirocin, a therapeutically comprise azithromycin, fluconazole, an excipient base pow effective amount of itraconazole, and an excipient base der comprising a blend of micronized Xylitol and poloxam powder comprising a blend of micronized Xylitol and poloX ers, and at least one additional anti-infective agent. amers, and instructions for using the compounded compo Disclosed herein is a container comprising a compounded sition. composition, wherein the compounded composition can 45 Disclosed herein is a kit, comprising: one or more con comprise mupirocin, nystatin, and an excipient base powder tainers, each comprising a compounded composition, comprising a blend of micronized Xylitol and poloxamers. wherein the compounded composition can comprise a thera Disclosed herein is a container comprising one or more peutically effective amount of mupirocin, a therapeutically capsules, each capsule comprising a compounded composi effective amount of itraconazole, and an excipient base tion, wherein the compounded composition can comprise 50 powder comprising a blend of micronized Xylitol and poloX mupirocin, nystatin, and an excipient base powder compris amers, a foot bath, and instructions for using the com ing a blend of micronized Xylitol and poloxamers. pounded composition. Disclosed herein is a container comprising a compounded Disclosed herein is a kit, comprising: one or more con composition, wherein the compounded composition can tainers, each comprising a compounded composition, comprise an anti-bacterial agent, nystatin, and an excipient 55 wherein the compounded composition can comprise a thera base powder comprising a blend of micronized Xylitol and peutically effective amount of azithromycin, a therapeuti poloxamers. cally effective amount of fluconazole, and an excipient base Disclosed herein is a container comprising a compounded powder comprising a blend of micronized Xylitol and poloX composition, wherein the compounded composition can aS. comprise mupirocin, an anti-fungal agent, and an excipient 60 Disclosed herein is a kit, comprising: one or more con base powder comprising a blend of micronized Xylitol and tainers, each comprising a compounded composition, poloxamers. wherein the compounded composition can comprise a thera Disclosed herein is a container comprising a compounded peutically effective amount of azithromycin, a therapeuti composition, wherein the compounded composition can cally effective amount of fluconazole, and an excipient base comprise mupirocin, nystatin, an excipient base powder 65 powder comprising a blend of micronized Xylitol and poloX comprising a blend of micronized Xylitol and poloxamers, amers, and instructions for using the compounded compo and at least one additional anti-infective agent. sition. US 9,707,229 B2 7 8 Disclosed herein is a kit, comprising: one or more con Disclosed herein is a kit, comprising: one or more con tainers, each comprising a compounded composition, tainers comprising a therapeutically effective amount of wherein the compounded composition can comprise a thera mupirocin and one or more containers comprising a thera peutically effective amount of azithromycin, a therapeuti peutically effective amount of nyStatin. cally effective amount of fluconazole, and an excipient base Disclosed herein is a kit, comprising: one or more con powder comprising a blend of micronized Xylitol and poloX tainers comprising a therapeutically effective amount of amers, a foot bath, and instructions for using the com mupirocin, one or more containers comprising a therapeu pounded composition. tically effective amount of nyStatin, and instructions for Disclosed herein is a kit comprising an anti-bacterial using the mupirocin and the nystatin. agent and an anti-fungal agent. 10 Disclosed herein is a kit, comprising: one or more con Disclosed herein is a kit, comprising: one or more con tainers comprising a therapeutically effective amount of tainers comprising a therapeutically effective amount of an mupirocin, one or more containers comprising a therapeu anti-bacterial agent and one or more containers comprising tically effective amount of nystatin, a foot bath, and instruc a therapeutically effective amount of an anti-fungal agent. tions for using the mupirocin and the nystatin. Disclosed herein is a kit, comprising: one or more con 15 Disclosed herein is a kit, comprising: one or more con tainers comprising a therapeutically effective amount of an tainers comprising a therapeutically effective amount of anti-bacterial agent or one or more containers comprising a mupirocin, one or more containers comprising a therapeu therapeutically effective amount of an anti-fungal agent, a tically effective amount of nystatin, a foot bath, one or more foot bath, and instructions for using the anti-bacterial agent scoops, a mixing container, one or more keys, a diluent, and and the anti-fungal agent. instructions for using the mupirocin, and the nyStatin. Disclosed herein is a kit, comprising: one or more con Disclosed herein is a method of making a compounded tainers comprising a therapeutically effective amount of an composition comprising an anti-bacterial agent and an anti anti-bacterial agent or one or more containers comprising a fungal agent. therapeutically effective amount of an anti-fungal agent, a Disclosed herein is a method of making a compounded foot bath, and instructions for using the anti-bacterial agent 25 composition, the method comprising: mixing a therapeuti and the anti-fungal agent. cally effective amount of an anti-bacterial agent and a Disclosed herein is a kit, comprising: one or more con therapeutically effective amount of an anti-fungal agent with tainers comprising a therapeutically effective amount of an excipient base powder comprising a blend of micronized mupirocin and one or more containers comprising a thera Xylitol and poloxamers to make a homogenous compounded peutically effective amount of itraconazole. 30 composition. Disclosed herein is a kit, comprising: one or more con Disclosed herein is a method of making a compounded tainers comprising a therapeutically effective amount of composition, the method comprising: mixing a therapeuti mupirocin and one or more containers comprising a thera cally effective amount of mupirocin and a therapeutically peutically effective amount of itraconazole, and instructions effective amount of itraconazole with an excipient base for using the mupirocin and the itraconazole. 35 powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a kit, comprising: one or more con amers to make a homogenous compounded composition. tainers comprising a therapeutically effective amount of Disclosed herein is a method of making a compounded mupirocin, one or more containers comprising a therapeu composition, the method comprising: mixing a therapeuti tically effective amount of itraconazole, a foot bath, and cally effective amount of mupirocin and a therapeutically instructions for using the mupirocin and the itraconazole. 40 effective amount of an anti-fungal agent with an excipient Disclosed herein is a kit, comprising: one or more con base powder comprising a blend of micronized Xylitol and tainers comprising a therapeutically effective amount of poloxamers to make a homogenous compounded composi mupirocin, one or more containers comprising a therapeu tion. tically effective amount of itraconazole, a foot bath, one or Disclosed herein is a method of making a compounded more Scoops, one or more mixing containers, a diluent, and 45 composition, the method comprising: mixing a therapeuti instructions for using the mupirocin and the itraconazole. cally effective amount of an anti-bacterial agent and a Disclosed herein is a kit, comprising: one or more con therapeutically effective amount of itraconazole with an tainers comprising a therapeutically effective amount of excipient base powder comprising a blend of micronized azithromycin and one or more containers comprising a Xylitol and poloxamers to make a homogenous compounded therapeutically effective amount of fluconazole. 50 composition. Disclosed herein is a kit, comprising: one or more con Disclosed herein is a method of making a compounded tainers comprising a therapeutically effective amount of composition, the method comprising: mixing a therapeuti azithromycin, one or more containers comprising a thera cally effective amount of azithromycin and a therapeutically peutically effective amount of fluconazole, and instructions effective amount of fluconazole with an excipient base for using the mupirocin and the itraconazole. 55 powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a kit, comprising: one or more con amers to make a homogenous compounded composition. tainers comprising a therapeutically effective amount of Disclosed herein is a method of making a compounded azithromycin, one or more containers comprising a thera composition, the method comprising: mixing a therapeuti peutically effective amount of fluconazole, a foot bath, and cally effective amount of azithromycin and a therapeutically instructions for using the mupirocin and the itraconazole. 60 effective amount of an anti-fungal agent with an excipient Disclosed herein is a kit, comprising: one or more con base powder comprising a blend of micronized Xylitol and tainers, each comprising a therapeutically effective amount poloxamers to make a homogenous compounded composi of azithromycin, one or more containers comprising a thera tion. peutically effective amount of fluconazole, a foot bath, one Disclosed herein is a method of making a compounded or more scoops, one or more mixing containers, a diluent, 65 composition, the method comprising: mixing a therapeuti and instructions for using the azithromycin and the flucon cally effective amount of an anti-bacterial agent and a azole. therapeutically effective amount of fluconazole with an US 9,707,229 B2 10 excipient base powder comprising a blend of micronized Disclosed herein is a method of treating or preventing an Xylitol and poloxamers to make a homogenous compounded infection, the method comprising: (i) mixing a compounded composition. composition comprising mupirocin and itraconazole with a Disclosed herein is a method of making a compounded diluent to create a solution; (ii) adding the solution to water composition, the method comprising: mixing a therapeuti 5 contained within a foot bath; (iii) agitating the water con cally effective amount of azithromycin and a therapeutically tained within the foot bath; and (iv) contacting the agitated effective amount of fluconazole with an excipient base water with at least part of one or both feet of a subject. powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a method of treating or preventing an amers to make a homogenous compounded composition, infection, the method comprising: (i) adding a compounded and encapsulating the homogenous ccmpounded composi 10 composition comprising azithromycin and fluconazole to water contained within a foot bath; (ii) agitating the water tion in one or more capsules. contained within the foot bath; and (iii) contacting the Disclosed herein is a method of making a compounded agitated water with at least a part of one or both feet of a composition, the method comprising: mixing a therapeuti Subject. cally effective amount of mupirocin and a therapeutically 15 Disclosed herein is a method of treating or preventing an effective amount of nystatin with an excipient base powder infection, the method comprising: (i) mixing a compounded comprising a blend of micronized Xylitol and poloxamers to composition comprising azithromycin and fluconazole with make a homogenous compounded composition. a diluent to create a solution; (ii) adding the Solution to water Disclosed herein is a method of making a compounded contained within a foot bath; (iii) agitating the water con composition, the method comprising: mixing a therapeuti tained within the foot bath; and (iv) contacting the agitated cally effective amount of mupirocin and a therapeutically water with at least part of one or both feet of a subject. effective amount of an anti-fungal agent with an excipient Disclosed herein is a method of treating or preventing an base powder comprising a blend of micronized Xylitol and infection, the method comprising: (i) adding a compounded poloxamers to make a homogenous compounded composi composition comprising mupirocin and nyStatin to water tion. 25 contained within a foot bath; (ii) agitating the water con Disclosed herein is a method of making a compounded tained within the foot bath; and (iii) contacting the agitated composition, the method comprising: mixing a therapeuti water with at least a part of one or both feet of a subject. cally effective amount of an anti-bacterial agent and a Disclosed herein is a method of treating or preventing an therapeutically effective amount of nyStatin with an excipi infection, the method comprising: (i) mixing a compounded ent base powder comprising a blend of micronized Xylitol 30 composition comprising mupirocin and nystatin with a and poloxamers to make a homogenous compounded com diluent to create a solution; (ii) adding the solution to water position. contained within a foot bath; (iii) agitating the water con Disclosed herein is a method of treating or preventing an tained within the foot bath; and (iv) contacting the agitated infection, the method comprising: (i) adding a compounded water with at least part of one or both feet of a subject. composition to water contained within a foot bath; (ii) 35 Disclosed herein is a method of treating or preventing an agitating the water contained within the foot bath; and (iii) infection, the method comprising: (i) adding one or more contacting the agitated water with at least a part of one or powders to water contained within a foot bath; (ii) agitating both feet of a subject. the water contained within the foot bath; and (iii) contacting Disclosed herein is a method of treating or preventing an the agitated water with at least a part of one or both feet of infection, the method comprising: (i) mixing a compounded 40 a Subject. composition with a diluent to create a solution; (ii) adding Disclosed herein is a method of treating or preventing an the solution to water contained within a foot bath; (iii) infection, the method comprising: (i) adding an anti-bacte agitating the water contained within the foot bath; and (iv) rial agent to water contained within a foot bath; (ii) adding contacting the agitated water with at least part of one or both an anti-fungal agent to the water, (iii) agitating the water feet of a subject. 45 contained within the foot bath; and (iv) contacting the Disclosed herein is a method of treating or preventing an agitated water with at least a part of one or both feet of a infection, the method comprising: (i) adding a compounded Subject. composition comprising an anti-bacterial agent and an anti Disclosed herein a method of treating or preventing an fungal agent to water contained within a foot bath; (ii) infection, the method comprising: (i) mixing an anti-bacte agitating the water contained within the foot bath; and (iii) 50 rial agent, an anti-fungal agent, and a diluent to form a contacting the agitated water with at least a part of one or Solution; (ii) adding the solution to water contained within a both feet of a subject. foot bath; (iii) agitating the water contained within the foot Disclosed herein is a method of treating or preventing an bath; and (iv) contacting the agitated water with at least part infection, the method comprising: (i) mixing a compounded of one or both feet of a subject. composition comprising an anti-bacterial agent and an anti 55 Disclosed herein is a method of treating or preventing an fungal agent with a diluent to create a solution; (ii) adding infection, the method comprising: (i) adding mupirocin to the solution to water contained within a foot bath; (iii) water contained within a foot bath; (ii) adding an itracon agitating the water contained within the foot bath; and (iv) azole to the water, (iii) agitating the water contained within contacting the agitated water with at least part of one or both the foot bath; and (iv) contacting the agitated water with at feet of a subject. 60 least a part of one or both feet of a subject. Disclosed herein is a method of treating or preventing an Disclosed herein a method of treating or preventing an infection, the method comprising: (i) adding a compounded infection, the method comprising: (i) mixing mupirocin, composition comprising mupirocin and itraconazole to itraconazole, and a diluent to form a solution; (ii) adding the water contained within a foot bath; (ii) agitating the water Solution to water contained within a foot bath; (iii) agitating contained within the foot bath; and (iii) contacting the 65 the water contained within the foot bath; and (iv) contacting agitated water with at least a part of one or both feet of a the agitated water with at least part of one or both feet of a Subject. Subject. US 9,707,229 B2 11 12 Disclosed herein is a method of treating or preventing an “characterized by', and is inclusive or open-ended. “Com infection, the method comprising: (i) adding azithromycinto prising does not exclude additional, unrecited components water contained within a foot bath; (ii) adding fluconazole to or steps. the water, (iii) agitating the water contained within the foot As used herein when referring to any numerical value, the bath; and (iv) contacting the agitated water with at least a term “about’ means a value falling within a range that is part of one or both feet of a subject. +10% of the stated value. Disclosed herein a method of treating or preventing an Ranges can be expressed herein as from “about one infection, the method comprising: (i) mixing azithromycin, particular value, and/or to “about another particular value. fluconazole, and a diluent to form a solution; (ii) adding the When Such a range is expressed, a further aspect includes Solution to water contained within a foot bath; (iii) agitating 10 from the one particular value and/or to the other particular the water contained within the foot bath; and (iv) contacting value. Similarly, when values are expressed as approxima the agitated water with at least part of one or both feet of a tions, by use of the antecedent “about, it will be understood Subject. that the particular value forms a further aspect. It will be Disclosed herein is a method of treating or preventing an further understood that the endpoints of each of the ranges infection, the method comprising: (i) adding mupirocin to 15 are significant both in relation to the other endpoint and water contained in a foot bath, (ii) adding nystatin to the independently of the other endpoint. It is also understood water, (iii) agitating the water contained within the footbath; that there are a number of values disclosed herein, and that and (iv) contacting the agitated water with at least a part of each value is also herein disclosed as “about that particular one or both feet of a subject. value in addition to the value itself. For example, if the value Disclosed herein is a method of treating or preventing an “10' is disclosed, then “about 10” is also disclosed. It is also infection, the method comprising: (i) adding mupirocin to a understood that each unit between two particular units are mixing container, (ii) adding nystatin to the mixing con also disclosed. For example, if 10 and 15 are disclosed, then tainer, (iii) adding a diluent to the mixing container, (iv) 11, 12, 13, and 14 are also disclosed. mixing the mupirocin, nystatin, and diluent in the mixing References in the specification and concluding claims to container to form a solution, (v) adding the solution to water 25 parts by weight of a particular element or component in a contained within a foot bath; (vi) agitating the water con composition denotes the weight relationship between the tained within the foot bath; and (vii) contacting the agitated element or component and any other elements or compo water with at least a part of one or both feet of a subject. nents in the composition or article for which a part by weight is expressed. Thus, in a compound containing 2 parts by DETAILED DESCRIPTION OF THE 30 weight of component X and 5 parts by weight component Y. INVENTION X and Y are present at a weight ratio of 2:5, and are present in such ratio regardless of whether additional components The present invention can be understood more readily by are contained in the compound. reference to the following detailed description of the inven As used herein, the terms “optional' or “optionally' tion and the Examples included therein. 35 means that the Subsequently described event or circumstance Before the present compounds, compositions, articles, can or cannot occur, and that the description includes systems, devices, and/or methods are disclosed and instances where said event or circumstance occurs and described, it is to be understood that they are not limited to instances where it does not. For example, in an aspect, a specific synthetic methods unless otherwise specified, or to disclosed method can optionally comprise one or more particular reagents unless otherwise specified, as such may, 40 additional steps, such as, for example, repeating an admin of course, vary. It is also to be understood that the termi istering step or altering an administering step. nology used herein is for the purpose of describing particular As used herein, the term “capsule' includes a soft or hard aspects only and is not intended to be limiting. Although any shell capsule. A capsule shell can be a unibody delivery methods and materials similar or equivalent to those vehicle or can be comprised of two capsule shell pieces. In described herein can be used in the practice or testing of the 45 an aspect, the longer capsule shell piece can be called the present invention, example methods and materials are now “body' and the smaller capsule shell piece can be called the described. 'cap'. The body and the cap can engage with each other as All publications mentioned herein are incorporated herein one shell body. As known to the art, capsule sizes can differ by reference to disclose and describe the methods and/or considering various factors that are tailored for any particu materials in connection with which the publications are 50 lar application, such as dosage amount or route of admin cited. The publications discussed herein are provided solely istration. Capsules can be manufactured to achieve a variety for their disclosure prior to the filing date of the present of capsule shell thicknesses. The release characteristics of a application. Nothing herein is to be construed as an admis capsule can vary depending on the capsule shell thickness sion that the present invention is not entitled to antedate Such and composition. Standard capsule sizes are known in the publication by virtue of prior invention. 55 art, and include, but are not limited to, the following sizes: A. Definitions Su07 (-28 mL), 7 (-24 mL), 10 (~18 mL), 11 (~10 mL), As used in the specification and the appended claims, the 12el (-7.5 mL), 12 (-5 mL), 13 (-3.2 mL), 000 (~1.37 mL), singular forms “a”, “an’, and “the include plural referents 00 (-0.95 mL), 0 (-0.68 mL), 1 (-0.50 mL), 2 (-0.37 mL), unless the context clearly dictates otherwise. 3 (-0.30 mL), 4 (-0.21 mL), and 5 (-0.13 mL). Actual The phrase “consisting essentially of limits the scope of 60 Volumes in mL are shown in parenthesis. Capsules for oral a claim to the recited components in a composition or the administration typically range from a size 5 (volume of 0.1 recited steps in a method as well as those that do not mL) capsule to a size 000 (volume of 1.37 mL) capsule. materially affect the basic and novel characteristic or char The capacity of a capsule measures how much of a acteristics of the claimed composition or claimed method. disclosed compounded composition or a disclosed agent that The phrase “consisting of excludes any component, step, or 65 a capsule can hold or contain. The capacity of a capsule element that is not recited in the claim. The phrase “com depends largely on the density of the composition (compo prising is synonymous with "including”, “containing, or sitions and anti-infective agents vary widely in density). A US 9,707,229 B2 13 14 capsule can hold less of a composition or an anti-infective having a bacterial infection. In an aspect, a bacterial infec agent with a low density (i.e., around 0.6 g/mL) and can hold tion or Suspected bacterial infection can affect at least a more of a composition or an agent having a high density portion of one or both feet of the subject. In an aspect, a (i.e., 1.2 g/mL). The table below shows the approximate bacterial infection or suspected bacterial infection can affect capacity (in milligrams) of various capsules (e.g., capsule 5 another appendage, such as at least a portion of one or both size 000 to capsule size 4) across a range of densities for a of the Subjects hands. In an aspect, a fungal infection or disclosed compounded composition or a disclosed anti Suspected fungal infection can affect at least a portion of one infective agent (i.e., an anti-bacterial agent or an anti-fungal or both feet of the Subject. In an aspect, a fungal infection or agent). Suspected fungal infection can affect another appendage, 10 such as at least a portion of one or both of the subjects hands. Powder Capacity (ng) for Various Capsule Sizes As used herein, the term “treatment” refers to the medical Density OOO OO O 1 2 3 4 management of a patient with the intent to cure, ameliorate, 0.6 g/ml 822 570 408 288 216 162 120 15 stabilize, or prevent a disease, pathological condition, or 0.8 g/ml 1096 760 544 384 288 216 160 disorder (such as, for example, a bacterial infection, a 1.0 g/ml 1370 950 68O 480 360 270 2OO Suspected bacterial infection, a fungal infection, or a sus 1.2 g/ml 1644 1140 816 576 432 324 240 pected fungal infection, or both). This term includes active treatment, that is, treatment directed specifically toward the As used herein, the term “subject” refers to the target of 20 improvement of a disease, pathological condition, or disor administration, e.g., an animal. The term "subject' also der, and also includes causal treatment, that is, treatment includes domesticated animals (e.g., cats, dogs, etc.), live directed toward removal of the cause of the associated Stock (e.g., cattle, horses, pigs, sheep, goats, etc.), and disease, pathological condition, or disorder. In addition, this laboratory animals (e.g., mouse, rabbit, rat, guinea pig, fruit term includes palliative treatment, that is, treatment fly, etc.). Thus, the subject of the herein disclosed methods 25 designed for the relief of symptoms rather than the curing of can be a vertebrate, such as a mammal, a fish, a bird, a the disease, pathological condition, or disorder, preventative reptile, or an amphibian. Alternatively, the subject of the treatment, that is, treatment directed to minimizing or par herein disclosed methods can be a human, non-human tially or completely inhibiting the development of the asso primate, horse, pig, rabbit, dog, sheep, goat, cow, cat, guinea ciated disease, pathological condition, or disorder, and Sup pig, or rodent. The term does not denote a particular age or 30 portive treatment, that is, treatment employed to Supplement sex. Thus, adult and newborn Subjects, as well as fetuses, another specific therapy directed toward the improvement of whether male or female, are intended to be covered. In an the associated disease, pathological condition, or disorder. In aspect, a Subject can be a human patient. A Subject can have various aspects, the term covers any treatment of a Subject, diabetes. A subject can be obese. A subject can have circu including a mammal (e.g., a human), and includes: (i) latory issues. A subject can have a bacterial infection, be 35 preventing the disease from occurring in a subject that can Suspected of having a bacterial infection, or be at risk of be predisposed to the disease but has not yet been diagnosed developing a bacterial infection. A subject can have a fungal as having it; (ii) inhibiting the disease, i.e., arresting its infection, be suspected of having a fungal infection, or be at development; or (iii) relieving the disease, i.e., causing risk of developing a fungal infection. For example, a subject regression of the disease. can have damaged or moist skin, can have chronic disease, 40 In an aspect, “treating” means eradicating a bacterial or can be immunocompromised. A Subject can have a infection, a fungal infection, a Suspected bacterial infection, bacterial infection and a fungal infection, be suspected of a Suspected fungal infection, or a combination thereof. In an having a bacterial infection and a fungal infection, or be at aspect, “treating means reducing the effects of a bacterial risk of developing a bacterial infection and a fungal infec infection or fungal infection or symptoms of a bacterial tion. 45 infection or a fungal infection. Thus, in an aspect of a For example, a Subject at risk of developing a bacterial disclosed method, treating can refer to a 10%, 20%, 30%, infection can have, for example, risk factors for developing 40%, 50%, 60%, 70%, 80%, 90%, or 100% reduction in the a bacterial infection (e.g., have damaged or moist skin, have severity of an established bacterial infection or an estab chronic disease, and/or be immunocompromised). For lished fungal infection or in the symptoms of a bacterial example, a Subject at risk for developing a bacterial infection 50 infection or a fungal infection. For example, a method for can be exposed to a bacterium or bacteria due to employ treating a bacterial infection or fungal infection can reduce ment (e.g., a health care worker) or due to the prevalence of one or more symptoms of a bacterial infection, a fungal a bacterium or bacteria at a specific location (e.g., a hospi infection, or both in a subject by 10% as compared to a tal). control. In an aspect, a reduction of one or more symptoms For example, a Subject at risk of developing a fungal 55 can be 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, infection can have, for example, risk factors for developing or any percent reduction in between 10% and 100% as a fungal infection (e.g., have damaged or moist skin, have compared to a control. It is understood that treatment does chronic disease, and/or be immunocompromised). For not necessarily refer to a cure or complete ablation or example, a subject at risk for developing a fungal infection eradication of the bacterial infection or the fungal infection, can be exposed to a fungus or fungi due to employment (e.g., 60 or both. However, in an aspect, treatment can refer to a cure a health care worker) or due to the prevalence of a fungus or or complete ablation or eradication of the bacterial infection, fungi at a specific location (e.g., a hospital). the fungal infection, or both. A “patient” refers to a subject afflicted with one or more As used herein, the term “prevent' or “preventing” refers diseases or disorders. In an aspect, a patient can refer to a to precluding, averting, obviating, forestalling, stopping, or Subject that has been diagnosed with or is suspected of 65 hindering something from happening, especially by advance having a fungal infection. In an aspect, a patient can refer to action. It is understood that where reduce, inhibit or prevent a subject that has been diagnosed with or is Suspected of are used herein, unless specifically indicated otherwise, the US 9,707,229 B2 15 16 use of the other two words is also expressly disclosed. In an As used herein, a “foot bath” refers to a container that can aspect, preventing a bacterial infection, fungal infection, or hold some volume (e.g., about 15 liters to about 30 liters) of both is intended. aqueous Solution (e.g., water) and is designed to physically As used herein, the term "diagnosed” means having been accommodate at least a portion of one or both feet of a Subjected to a physical examination by a person of skill, for subject. Foot baths are known to the skilled person. A foot example, a physician, and found to have a condition that can bath can comprise several features or agents that effect be diagnosed or treated by the compounds, compositions, various functions. For example, a foot bath can comprise agents, or methods disclosed herein. For example, "diag one or more lights or light-emitting devices, a mechanical nosed with a bacterial infection” means having been sub agitation agent (e.g., one or more jets or bubble makers) to jected to a physical examination by a person of skill, for 10 physically agitate the enclosed water, a bubble agent to example, a physician, and found to have a condition that can create bubbles within the enclosed water, a heating agent to be diagnosed or can be treated by a disclosed compound or heat the enclosed water, a vibration agent to vibrate the composition or agent that can prevent or inhibit a bacterial enclosed water (e.g., a high frequency vibration massage), infection. For example, "Suspected of having a bacterial an infrared device to provide infrared light to a foot or feet infection' can mean having been subjected to a physical 15 of the Subject, a massage agent (e.g., a roller) that provides examination by a person of skill, for example, a physician, massaging contact to at least a portion of one or both feet, and found to have a condition that can be likely be diagnosed a pedicure agent that can clean or contact a foot or feet with as or can likely be treated by a disclosed compound or a pumice, or a combination thereof. In an aspect, an agitation composition or agent that can prevent or inhibit a bacterial agent or an agitator can be coupled to both a motor and the infection, or it can mean that the subject believes that he or foot bath. Motors and agitators are known to the art. In an she has a bacterial infection. For example, “diagnosed with aspect, a foot bath can comprise one or more splash guards a fungal infection' means having been Subjected to a physi and other spill-resistant features to ensure that the water cal examination by a person of skill, for example, a physi remains enclosed within a container. A foot bath may also cian, and found to have a condition that can be diagnosed or accommodate a Subject’s calves, meaning that the container can be treated by a disclosed compound or composition or 25 is “deep” so as to allow the enclosed water to contact both agent that can prevent or inhibit a fungal infection. For the feet and at least a portion of the calves of the subject. example, 'Suspected of having a fungal infection' can mean Several manufacturers market foot baths including PIBB, having been subjected to a physical examination by a person Dr. Scholls, Kendal, Conair, and Brookstone. of skill, for example, a physician, and found to have a As used herein, a "scoop” refers to tool that can be used condition that can be likely be diagnosed as or can likely be 30 to measure or dispense a disclosed a compounded compo treated by a disclosed compound or composition or agent sition, a disclosed powder, or a disclosed anti-infective that can prevent or inhibit a fungal infection, or it can mean agent. In an aspect, a Scoop can have a pre-determined size that the subject believes that he or she has a fungal infection. that can measure a pre-determined amount. In an aspect, a As used herein, the terms “administering and “adminis scoop can measure or dispense an amount of about 1 g to tration” refer to any method of providing a disclosed com 35 about 10 g. In an aspect, a scoop can measure about 1 g, position, compounded composition, anti-infective agent, or about 2 g, about 3 g, about 4 g, about 5 g, about 6 g, about a pharmaceutical preparation to a Subject. Such methods are 7 g, about 8 g, about 9 g, or about 10 g. In an aspect, a Scoop well known to those skilled in the art and include, but are not can measure or dispense an amount of 10 g or more. For limited to: oral administration, transdermal administration, example, in an aspect, a scoop can measure or dispense an administration by inhalation, nasal administration, topical 40 amount of about 1 mg to about 1 g. In an aspect, a Scoop can administration, intravaginal administration, ophthalmic measure about 1 mg, about 100 mg, about 200 mg, about 300 administration, intraaural administration, intracerebral mg, about 400 mg, about 500 mg, about 600 mg, about 700 administration, rectal administration, Sublingual administra mg, about 800 mg, about 900 g, or about 1 g. In an aspect, tion, buccal administration, and parenteral administration, a scoop can measure or dispense an amount of about 250 mg. including injectable Such as intravenous administration, 45 In an aspect, a Scoop can measure or dispense an amount of intra-arterial administration, intramuscular administration, about 500 mg. In an aspect, a Scoop can measure or dispense and Subcutaneous administration. Administration can be an amount of about 1.5 g. continuous or intermittent. In various aspects, a disclosed As used herein, a "scoop” can also refer to tool that can composition, compounded composition, or anti-infective be used to measure or dispense a disclosed diluent. In an agent can be administered therapeutically; that is, adminis 50 aspect, a scoop can have a pre-determined size that can tered to treat an existing disease or condition. In further measure a pre-determined Volume. For example, in an various aspects, a disclosed composition, compounded com aspect, a Scoop can measure or dispense a volume of about position, or anti-infective agent can be administered pro 1 mL to about 30 mL. In an aspect, a scoop can measure phylactically; that is, administered for prevention of a dis about 1 mL, about 2 mL, about 3 mL, about 4 mL, about 5 ease or condition. In an aspect, the skilled person can 55 mL, about 6 mL, about 7 mL, about 8 mL, about 9 mL, about determine an efficacious dose, an efficacious schedule, and 10 mL, about 15 mL, about 20 mL, about 25 mL, or about an efficacious route of administration for a disclosed com 30 mL. In an aspect, a Scoop can measure or dispense an position, compounded composition, or anti-infective agent amount of 10 mL or more. In an aspect, a Scoop can measure So as to treat a subject or inhibit or prevent an inflammatory or dispense an amount of about 15 mL. reaction. In an aspect, the skilled person can also alter, 60 As used herein, a “mixing container” can be a container change, or modify an aspect of an administering step so as that can accommodate one more liquids (such as a diluent, to improve efficacy of a disclosed composition, compounded for example) and one or more disclosed compositions or composition, or anti-infective agent. In an aspect, adminis disclosed anti-infective agents. A mixing container can have tering means contacting at least a portion of one foot or both a lid or a cover, which facilitates the mixing of any liquid feet of a subject with agitated water comprising a disclosed 65 with any Solid that has been added to the container. A mixing composition, compounded composition, or anti-infective container can be used to generate a solution. In an aspect, a agent in a foot bath. mixing container can contain an amount from about 2 US 9,707,229 B2 17 18 ounces to about 30 ounces. In an aspect, a mixing container amount of time required to mix the recited components so as can contain an amount of about 6 ounces. In an aspect, a to achieve a homogenous compounded composition. mixing container can contain an amount of about 16 ounces. Also, in an aspect, “mixing can be used to describe the The art is familiar with mixing containers and mixing process of making a solution by adding one or more of a containers are commercially available. 5 disclosed compounded composition, a disclosed composi As used herein, "modifying the method can comprise tion, or a disclosed anti-infective agent to a diluent. For modifying or changing one or more features or aspects of example, mixing means to physically combine one or more one or more steps of a disclosed method. For example, in an of a disclosed compounded composition, a disclosed com aspect, a method can be altered by changing the amount of position, or a disclosed anti-infective agent with a diluent. 10 "Mixing can occur in a disclosed mixing container. In an a disclosed compounded composition, a disclosed compo aspect, a mixing container can have a pre-determined size sition, or a disclosed anti-infective agent added to a foot that can measure or hold a pre-determined amount or bath, by changing the frequency of the Subjects use of the Volume. For example, in an aspect, a mixing container can foot bath, or by changing the duration of time that the measure or hold an amount of about 1 ounces to about 30 subjects foot or feet contact the water contained within the ounces. In an aspect, mixing container can measure or hold foot bath, or a combination thereof. 15 about 1 ounce, 2 ounces, 3 ounces, 4 ounces, 5 ounces, 6 As used herein, poloxamers are non-ionic poly (ethylene ounces, 7 ounces, 8 ounces, 9 ounces, 10 ounces, 11 ounces, oxide) (PEO)-poly (propylene oxide) (PPO) copolymers. 12 ounces, 13 ounces, 14 ounces, 15 ounces, 16 ounces, 17 Poloxamers can be used in pharmaceutical formulations as ounces, 18 ounces, 19 ounces, 20 ounces, 21 ounces, 22 Surfactants, emulsifying agents, Solubilizing agent, dispers ounces, 23 ounces, 24 ounces, 25 ounces, 26 ounces, 27 ing agents, and in vivo absorbance enhancer. Poloxamers are ounces, 28 ounces, 29 ounces, or 30 ounces. In an aspect, a often considered as “functional excipients' because they are mixing container can measure or hold about 6 ounces. In an essential components, and play an important role in the aspect, a mixing container can measure or hold about 16 formulation. Poloxamers are synthetic triblock copolymers OCCS, with the following formula: As used herein, an anti-infective agent can be an anti bacterial agent, an anti-fungal agent, a combination of 25 anti-bacterial agents, a combination of anti-fungal agents, or CH3 a combination of anti-bacterial agents and anti-fungal agents. CH O -N CH O Anti-bacterial agents are known to the art. For example, Ho-1 No1 C O N1SN the art generally recognizes several categories of anti H H H 30 bacterial agents including (1) enicillins, (2) cephalosporins, (3) fluoroquinolones, (4) aminoglycosides, (5) mono The term “contacting as used herein refers to bringing bactams, (6) carbapenems, (7) macrollides, and (8) other one or more disclosed compositions, disclosed compounded agents. For example, as used herein, an anti-bacterial agent compositions, or disclosed anti-infective agents together can comprise afenide, amikacin, amoxicillin, amplicillin, with water and an intended target (Such as at least a portion 35 arsphenamine, azithromycin, azlocillin, aztreonam, bacam of one or both feet of a Subject) or targeted area (such as an picillin, bacitracin, carbacephem (loracarbef), carbenicillin, area diagnosed with, Suspected of having a bacterial infec cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin, cef tion or a fungal infection, or Susceptible to developing a dinir, cefditoren, cefepime, cefixime, cefoperaZone, cefo bacterial infection or a fungal infection) in Such a manner taxime, cefoxitin, cefpodoxime, cefprozil, ceftazidime, cef that the disclosed composition, a disclosed compounded 40 tibuten, ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, composition, or a disclosed anti-infective agent can exert an cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin, effect on the intended target or targeted area either directly clarithromycin, clavulanic acid, clindamycin, cloxacillin, or indirectly. In an aspect, “contacting” means to insert or colimycin, colistimethate teicoplanin, colistin, demeclocy immerse at least a portion of one or both feet of a subject into cline, dicloxacillin, dirithromycin, doripenem, doxycycline, the water contained within a foot bath. efprozil, enoxacin, ertapenem, erythromycin, ethambutol, The term “mixing as used in a disclosed method of 45 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, making a compounded composition, for example, means to geldanamycin, gentamicin, grepafloxacin, herbimycin, imi physically combine the recited components so as to achieve penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin a homogenous compounded composition (which can be a eZolid, lomefloxacin, meropenem, meticillin, metronidazole, dry powder formulation). For example, in an aspect, an meZlocillin, minocycline, mitomycin, moxifloxacin, mupi 50 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor anti-bacterial agent and an anti-fungal agent can be mixed floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy with an excipient base powder, that is, an anti-bacterial cin, penicillin G, penicillin V, piperacillin, pivmecillinam, agent and an anti-fungal agent are physically combined with platensimycin, polymyxin B, prontosil, pvampicillin, an excipient base powder and shaken, or stirred, or agitated pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam So as to achieve a homogenous compounded composition. In pin, roXithromycin, sparfloxacin, spectinomycin, spiramy an aspect, multiple recited components can be mixed 55 together (i.e., anti-bacterial agent, an anti-fungal agent, an cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox excipient base powder, and one or more additional anti azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, infective agents (i.e., anti-bacterial agent and anti-fungal Sultamicillin, tellithromycin, tetracycline, thiamphenicol, agent). In an aspect, “mixing can also include sifting the ticarcillin, tobramycin, trimethoprim, trimethoprim-sul homogenous compounded composition though a fine mesh famethoxazole, troleandomycin, trovafloxacin, or a combi strainer. A suitable mixer is a TURBULAR mixer, which is 60 nation thereof. able to mix powdery substances with differing specific Anti-fungal agents are known to the art. The art generally weights and particle sizes. The mixing can be generally recognizes several categories of anti-fungal agents including performed for a pre-determined amount of time, i.e., for 10 (1) azoles (imidazoles), (2) antimetabolites, (3) allylamines, seconds, 20 seconds, 30 seconds, 45 seconds, 1 minute, 5 (4) morpholine, (5) glucan synthesis inhibitors (echinocan minute, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 65 dins), (6) polyenes, (7) benoxaaborale; (8) other antifungal/ minutes, 1 hour, 2 hours, 3 hours, or more. A person skilled onychomycosis agents, and (9) new classes of antifungal/ in the art could ascertain without undue experimentation, the onychomycosis agents. For example, as used herein, an US 9,707,229 B2 19 20 anti-fungal agent can comprise abafungin, albaconazole, Azithromycin is a semi-synthetic macrollide antibiotic amorolfin, amphotericinb, anidulafungin, bifonazole, buten structurally related to erythromycin. It has been used in the afine, butoconazole, candicidin, caspofungin, ciclopirox, treatment of Mycobacterium avium intracellulare infections, clotrimazole, econazole, fenticonazole, filipin, fluconazole, toxoplasmosis, and cryptosporidiosis. The molecular for flucytosine, griseofulvin, haloprogin, hamycin, isavucon mula for azithromycin is CH7NO. Azithromycin is azole, isoconazole, itraconazole, ketoconazole, micafungin, shown below. miconazole, naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial, posaconazole, ravuconazole, rimo cidin, Sertaconazole, Sulconazole, terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid, Voriconazole, or a 10 combination thereof. Mupirocin is an anti-bacterial agent that has excellent activity against gram-positive staphylococci and strepto cocci. Mupirocin is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and 15 wound healing. Mupirocin inhibits bacterial protein synthe sis by specific reversible binding to bacterial isoleucyl tRNA synthase. The molecular formula for mupirocin is CHO. Mupirocin is shown below.

35 Itraconazole is a synthetic triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ergosterol synthesis. Itraconazole has antimycotic proper ties. Formulated for both topical and systemic use, itracon azole preferentially inhibits fugal cytochrome P450 40 enzymes, resulting in a decrease in fungal ergosterol Syn thesis. Because of its low toxicity profile, this agent can be used for long-term maintenance treatment of chronic fungal infections. The molecular formula for itraconazole is CHCNO. Itraconazole is shown below.

C US 9,707,229 B2 21 22 Fluconazole is a synthetic triazole with antifungal activ as, for example, a bacterial infection or a fungal infection ity. Fluconazole preferentially inhibits fungal cytochrome that affects one or more of a subjects appendages (e.g., at P450 sterol C-14 alpha-demethylation, resulting in the accu least a portion of one or both feet). Methods and techniques mulation of fungal 14 alpha-methyl sterols, the loss of used to determining the presence and/or severity of an normal fungal sterols, and fungistatic activity. Mammalian 5 infection are typically known to the medical arts. For cell demethylation is much less sensitive to fluconazole example, the art is familiar with the ways to identify and/or inhibition. The mechanism of action of fluconazole is as a diagnose the presence, severity, or both of a bacterial infec cytochrome P450 2C19 inhibitor, cytochrome P450 3A4 tion, a fungal infection, or both. inhibitor, and cytochrome P450 2C9 inhibitor. The molecu As used herein, “effective amount” and “amount effec lar formula for fluconazole is CHF.N.O. Fluconazole is 10 tive' can refer to an amount that is sufficient to achieve the shown below. desired result such as, for example, the treatment and/or prevention of a bacterial infection or a suspected bacterial infection or a fungal infection or a Suspected fungal infec N 15 tion. As used herein, the terms “effective amount” and “amount effective' can refer to an amount that is sufficient X to achieve the desired an effect on an undesired condition H N (e.g., a bacterial or fungal infection). For example, a “thera Y peutically effective amount” refers to an amount that is sufficient to achieve the desired therapeutic result or to have F N1\ an effect on undesired symptoms, but is generally insuffi cient to cause adverse side effects. The specific therapeuti cally effective dose level for any particular patient will depend upon a variety of factors including the disorder being 25 treated and the severity of the disorder; the specific compo sition employed; the age, body weight, general health, sex and diet of the patient; the time of administration; the route The term “pharmaceutically acceptable' describes a of administration; the rate of excretion of the specific material that is not biologically or otherwise undesirable, compound employed; the duration of the treatment; drugs i.e., without causing an unacceptable level of undesirable 30 used in combination or coincidental with the specific com biological effects or interacting in a deleterious manner. As pound employed and like factors well known in the medical used herein, the term “pharmaceutically acceptable carrier arts. For example, it is well within the skill of the art to start refers to sterile aqueous or nonaqueous Solutions, disper doses of a compound at levels lower than those required to sions, Suspensions or emulsions, as well as sterile powders achieve the desired therapeutic effect and to gradually for reconstitution into sterile injectable solutions or disper 35 increase the dosage until the desired effect is achieved. If sions just prior to use. Examples of Suitable aqueous and desired, then the effective daily dose can be divided into nonaqueous carriers, diluents, solvents or vehicles include multiple doses for purposes of administration. Conse water, ethanol, polyols (Such as glycerol, propylene glycol, quently, single dose compositions can contain Such amounts polyethylene glycol and the like), carboxymethylcellulose or submultiples thereof to make up the daily dose. The and suitable mixtures thereof, vegetable oils (such as olive 40 dosage can be adjusted by the individual physician in the oil) and injectable organic esters such as ethyl oleate. These event of any contraindications. Dosage can vary, and can be compositions can also contain adjuvants such as preserva administered in one or more dose administrations daily, for tives, wetting agents, emulsifying agents and dispersing one or several days. Guidance can be found in the literature agents. Prevention of the action of microorganisms can be for appropriate dosages for given classes of pharmaceutical ensured by the inclusion of various anti-bacterial and anti 45 products. In further various aspects, a preparation can be fungal agents such as paraben, chlorobutanol, phenol, Sorbic administered in a “prophylactically effective amount': that acid and the like. It can also be desirable to include isotonic is, an amount effective for prevention of a disease or agents such as Sugars, Sodium chloride and the like. Pro condition, such as, for example, a bacterial infection or a longed absorption of the injectable pharmaceutical form can fungal infection. be brought about by the inclusion of agents, such as alumi 50 As used herein, LoxaSperseTM refers to an excipient base num monostearate and gelatin, which delay absorption. powder comprising a blend of micronized Xylitol and poloX Injectable depot forms are made by forming microencapsule amers. LoxaSperse M is used as a chemical dispersing or matrices of the drug in biodegradable polymers such as solubilizing agent, thereby improving the solubility and polylactide-polyglycolide, poly(orthoesters) and poly(anhy dispersibility of poorly water soluble active pharmaceutical drides). Depending upon the ratio of drug to polymer and the 55 ingredients (APIs) or agents. LoxaSperseTM can be obtained nature of the particular polymer employed, the rate of drug from a bulk source. release can be controlled. Depot injectable formulations are As used herein, XyliFosTM refers to an excipient base also prepared by entrapping the drug in liposomes or micro powder comprising Xylitol, poloxamer 407, hydroxylpropyl emulsions which are compatible with body tissues. The betadex, and epigallocatechin gallate. XyliFosTM is used as injectable formulations can be sterilized, for example, by 60 a chemical dispersing or solubilizing agent, thereby improv filtration through a bacterial-retaining filter or by incorpo ing the solubility and dispersibility of poorly water soluble rating sterilizing agents in the form of sterile solid compo active pharmaceutical ingredients (APIs) or agents. In an sitions which can be dissolved or dispersed in sterile water aspect, infectious agents such as bacteria and fungi can or other sterile injectable media just prior to use. Suitable consume or uptake XyliFosTM, but cannot digest, process, or inert carriers can include Sugars Such as lactose. 65 excrete XyliFosTM. This leads to the infectious agent's death. As used herein, “determining can refer to measuring or XyliFosTM can be obtained from a bulk source. In an aspect, ascertaining the presence and severity of an infection, Such Xylifos US 9,707,229 B2 23 24 As described herein, the combined use of LoxaSperse and composition. In an aspect, the anti-bacterial agent can com XyliFoscan improve the efficiency and performance of the prise about 25% w/w of the compounded composition. disclosed compounded composition as XyliFos improves In an aspect, the anti-fungal agent can comprise from the Solubilizing and dispensing characteristics of LoxaS about 10% to about 40% w/w of the compounded compo perse. sition. In an aspect, the anti-fungal agent can comprise from Disclosed are the components to be used to prepare a about 15% to about 35% w/w of the compounded compo composition of the invention as well as the compositions sition. In an aspect, the anti-fungal agent can comprise from themselves to be used within the methods disclosed herein. about 20% to about 30% w/w of the compounded compo These and other materials are disclosed herein, and it is sition. In an aspect, the anti-fungal agent can comprise about understood that when combinations, Subsets, interactions, 10 25% w/w of the compounded composition. groups, etc. of these materials are disclosed that while In an aspect, the ratio of the anti-bacterial agent to the specific reference of each various individual and collective anti-fungal agent in the compounded composition can be combinations and permutation of these compounds cannot from about 1:4 to about 4:1. In an aspect, the ratio of the be explicitly disclosed, each is specifically contemplated and anti-bacterial agent to the anti-fungal agent can be about 1:1. described herein. For example, if a particular compound is 15 In an aspect, the ratio of the anti-bacterial agent to the disclosed and discussed and a number of modifications that anti-fungal agent can be about 1.25:1. For example, Table 1 can be made to a number of molecules including the presents a representative, but not exhaustive, listing of the '% compounds are discussed, specifically contemplated is each W/w of the components of a disclosed compounded com and every combination and permutation of the compound position. and the modifications that are possible unless specifically indicated to the contrary. Thus, if a class of molecules A, B, and Care disclosed as well as a class of molecules D, E, and TABLE 1. F and an example of a combination molecule, A-D is REPRESENTATIVE LISTING OF disclosed, then even if each is not individually recited each COMPONENTS (% WW) INA is individually and collectively contemplated meaning com 25 COMPOUNDED COMPOSITION binations, A-E, A-F B-D, B-E, B-F, C-D, C-E, and C-F are Loxasperse considered disclosed. Likewise, any Subset or combination Anti-Bacterial Anti-Fungal and/or Xylifos of these is also disclosed. Thus, for example, the Sub-group 10 1O-40 qS of A-E, B-F, and C-E would be considered disclosed. This 15 1O-40 qS concept applies to all aspects of this application including, 30 2O 1O-40 qS but not limited to, steps in methods of making and using the 25 1O-40 qS 30 10-40 qS compositions of the invention. Thus, if there are a variety of 35 1O-40 qS additional steps that can be performed it is understood that 40 1O-40 qS each of these additional steps can be performed with any 1O-40 10 qS specific embodiment or combination of embodiments of the 35 1O-40 15 qS methods of the invention. 1O-40 2O qS 1O-40 25 qS B. Compounded Compositions 1O-40 30 qS Disclosed herein is a compounded composition for treat 1O-40 35 qS ing an infection. 1O-40 40 qS 1. Compounded Composition Comprising an Anti-Bacterial 40 10 10 8O 15 15 70 Agent and an Anti-Fungal Agent 2O 2O 60 Disclosed herein can be a compounded composition com 25 25 50 prising an anti-bacterial agent, an anti-fungal agent, and an 30 30 40 excipient base powder comprising a blend of micronized 35 35 30 40 40 2O Xylitol and poloxamers. 45 In an aspect, the compounded composition can be a dry powder formulation. In an aspect, the anti-bacterial agent In an aspect, the anti-bacterial agent can comprise can be a dry powder. In an aspect, the anti-bacterial agent afenide, amikacin, amoxicillin, amplicillin, arsphenamine, can be an ointment. The anti-bacterial agent can be pure or azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra Substantially pure. The anti-bacterial agent can be obtained 50 cin, carbacephem (loracarbef), carbenicillin, cefaclor, from a bulk source. In an aspect, the anti-fungal agent can cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi be a dry powder. In an aspect, the anti-fungal agent can be toren, cefepime, cefixime, cefoperaZone, cefotaxime, an ointment. The anti-fungal agent can be pure or Substan cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, tially pure. The anti-fungal agent can be obtained from a ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha bulk source. 55 lexin, chloramphenicol, chlorhexidine, ciprofloxacin, In an aspect, the excipient base powder can comprise clarithromycin, clavulanic acid, clindamycin, cloxacillin, LoxasperseTM excipient base powder. In an aspect, the colimycin, colistimethate teicoplanin, colistin, demeclocy excipient base powder can comprise Loxasperse M excipient cline, dicloxacillin, dirithromycin, doripenem, doxycycline, base powder and XyliFosTM excipient base powder. In an efprozil, enoxacin, ertapenem, erythromycin, ethambutol, aspect, an excipient base powder can be obtained from a 60 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, bulk source. geldanamycin, gentamicin, grepafloxacin, herbimycin, imi In an aspect, the anti-bacterial agent can comprise from penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin about 10% to about 40% w/w of the compounded compo eZolid, lomefloxacin, meropenem, meticillin, metronidazole, sition. In an aspect, the anti-bacterial agent can comprise meZlocillin, minocycline, mitomycin, moxifloxacin, mupi from about 15% to about 35% w/w of the compounded 65 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor composition. In an aspect, the anti-bacterial agent can com floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy prise from about 20% to about 30% w/w of the compounded cin, penicillin G, penicillin V, piperacillin, pivmecillinam, US 9,707,229 B2 25 26 platensimycin, polymyxin B, prontosil, pvampicillin, In an aspect, the mupirocin can be a dry powder. In an pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam aspect, the mupirocin can be an ointment. The mupirocin can pin, roXithromycin, sparfloxacin, spectinomycin, spiramy be pure or substantially pure. The mupirocin can be obtained cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox from a bulk source. In an aspect, the anti-fungal agent can azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, be a dry powder. In an aspect, the anti-fungal agent can be Sultamicillin, tellithromycin, tetracycline, thiamphenicol, an ointment. The anti-fungal agent can be pure or Substan ticarcillin, tobramycin, trimethoprim, trimethoprim-sul tially pure. The anti-fungal agent can be obtained from a famethoxazole, troleandomycin, trovafloxacin, or a combi bulk source. nation thereof. In an aspect, the excipient base powder can comprise In an aspect, the anti-bacterial agent can comprise mupi 10 LoxasperseTM excipient base powder. In an aspect, the rocin. In an aspect, the anti-bacterial agent can comprise azithromycin. excipient base powder can comprise Loxasperse M excipient In an aspect, the anti-fungal agent can comprise aba base powder and XyliFosTM excipient base powder. In an fungin, albaconazole, amorolfin, amphotericin b, anidula aspect, an excipient base powder can be obtained from a bulk source. fungin, bifonazole, butenafine, butoconazole, candicidin, 15 caspofungin, ciclopiroX, clotrimazole, econazole, fenticon In an aspect, the anti-fungal agent can comprise aba azole, filipin, fluconazole, flucytosine, griseofulvin, halo fungin, albaconazole, amorolfin, amphotericin b, anidula progin, hamycin, isavuconazole, isoconazole, itraconazole, fungin, bifonazole, butenafine, butoconazole, candicidin, ketoconazole, micafungin, miconazole, naftifine, natamycin, caspofungin, ciclopiroX, clotrimazole, econazole, fenticon nystatin, omoconazole, oxiconazole, polygodial, posacon azole, filipin, fluconazole, flucytosine, griseofulvin, halo azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, progin, hamycin, isavuconazole, isoconazole, itraconazole, terbinafine, terconazole, tioconazole, tolnaftate, undecylenic ketoconazole, micafungin, miconazole, naftifine, natamycin, acid, Voriconazole, or a combination thereof. nystatin, omoconazole, oxiconazole, polygodial, posacon In an aspect, the anti-fungal agent can comprise itracon azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, azole. In an aspect, the anti-fungal agent can comprise 25 terbinafine, terconazole, tioconazole, tolnaftate, undecylenic fluconazole. In an aspect, the anti-fungal agent can comprise acid, Voriconazole, or a combination thereof. The anti nystatin. fungal agent can comprise itraconazole. In an aspect of a disclosed compounded composition, the In an aspect, the mupirocin can comprise from about 10% anti-bacterial agent can comprise mupirocin and the anti to about 40% w/w of the compounded composition. In an fungal agent can comprise itraconazole. In an aspect of a 30 aspect, the mupirocin can comprise from about 15% to about disclosed compounded composition, the anti-bacterial agent 35% w/w of the compounded composition. In an aspect, the can comprise azithromycin and the anti-fungal agent can mupirocin can comprise from about 20% to about 30% w/w comprise fluconazole. In an aspect of a disclosed com of the compounded composition. In an aspect, the mupirocin pounded composition, the anti-bacterial agent can comprise can comprise about 25% w/w of the compounded compo mupirocin and the anti-fungal agent can comprise nystatin. 35 sition. In an aspect, a disclosed compounded composition can In an aspect, the anti-fungal agent can comprise from comprise one or more additional anti-infective agents. In an about 10% to about 40% w/w of the compounded compo aspect, the additional anti-infective agent can be a dry sition. In an aspect, the anti-fungal agent can comprise from powder. In an aspect, the additional anti-infective agent can about 15% to about 35% w/w of the compounded compo be an ointment. The additional anti-infective agent can be 40 sition. In an aspect, the anti-fungal agent can comprise from pure or substantially pure. The additional anti-infective about 20% to about 30% w/w of the compounded compo agent can be obtained from a bulk source. In an aspect, the sition. In an aspect, the anti-fungal agent can comprise about additional anti-infective agent can be an anti-bacterial agent. 25% w/w of the compounded composition. Anti-bacterial agents are known to the art and discussed In an aspect, the ratio of the mupirocin to the anti-fungal Supra. In an aspect, the additional anti-infective agent can be 45 agent in the compounded composition can be from about 1:4 an anti-fungal agent. Anti-fungal agents are known to the art to about 4:1. In an aspect, the ratio of the mupirocin to the and discussed Supra. anti-fungal agent can be about 1:1. In an aspect, the ratio of In an aspect, a disclosed compounded composition can the mupirocin to the anti-fungal agent can be about 1.25:1. comprise one or more excipients or additives. In an aspect, See, e.g., Table 1. excipients or additives include, but are not limited to, the 50 In an aspect, a disclosed compounded composition can following: solvents, Surfactants, humectants, preservatives, comprise one or more additional anti-infective agents. In an flavorings, stabilizers (including antioxidants), binders, and aspect, the additional anti-infective agent can be a dry colorants. powder. In an aspect, the additional anti-infective agent can In an aspect, a disclosed compounded composition com be an ointment. The additional anti-infective agent can be prising an anti-bacterial agent and an anti-fungal agent can 55 pure or substantially pure. The additional anti-infective be encapsulated in one or more capsules. The art is familiar agent can be obtained from a bulk source. In an aspect, the with capsules, methods of making capsules, and methods of additional anti-infective agent can be an anti-bacterial agent. using capsules to encapsulate one or more disclosed com Anti-bacterial agents are known to the art and discussed positions or one or more disclosed agents. Supra. In an aspect, the additional anti-infective agent can be 2. Compounded Composition Comprising Mupirocin and an 60 an anti-fungal agent. Anti-fungal agents are known to the art Anti-Fungal Agent and discussed Supra. Disclosed herein is a compounded composition compris In an aspect, a disclosed compounded composition can ing mupirocin, an anti-fungal agent, and an excipient base comprise one or more excipients or additives. In an aspect, powder comprising a blend of micronized Xylitol and poloX excipients or additives include, but are not limited to, the aS. 65 following: solvents, Surfactants, humectants, preservatives, In an aspect, the compounded composition can be a dry flavorings, stabilizers (including antioxidants), binders, and powder formulation. colorants. US 9,707,229 B2 27 28 In an aspect, a disclosed compounded composition com following: solvents, Surfactants, humectants, preservatives, prising mupirocin and an anti-fungal agent can be encapsu flavorings, stabilizers (including antioxidants), binders, and lated in one or more capsules. The art is familiar with colorants. capsules, methods of making capsules, and methods of using In an aspect, a disclosed compounded composition com capsules to encapsulate one or more disclosed compositions prising an anti-bacterial agent and itraconazole can be or one or more disclosed agents. encapsulated in one or more capsules. The art is familiar 3. Compounded Composition Comprising an Anti-Bacterial with capsules, methods of making capsules, and methods of Agent and Itraconazole using capsules to encapsulate one or more disclosed com Disclosed herein is a compounded composition compris positions or one or more disclosed agents. ing an anti-bacterial agent, itraconazole, and an excipient 10 4. Compounded Composition Comprising Mupirocin and base powder comprising a blend of micronized Xylitol and Itraconazole poloxamers. Disclosed herein is a compounded composition compris In an aspect, the compounded composition can be a dry ing mupirocin, itraconazole, and an excipient base powder powder formulation. 15 comprising a blend of micronized Xylitol and poloxamers. In an aspect, the anti-bacterial agent can be a dry powder. In an aspect, the compounded composition can be a dry In an aspect, the anti-bacterial agent can be an ointment. The powder formulation. anti-bacterial agent can be pure or Substantially pure. The In an aspect, the mupirocin can be a dry powder. In an anti-bacterial agent can be obtained from a bulk source. In aspect, the mupirocin can be an ointment. The mupirocin can an aspect, the itraconazole can be a dry powder. In an aspect, be pure or substantially pure. The mupirocin can be obtained the itraconZazole can be an ointment. The itraconazole can from a bulk source. In an aspect, the itraconazole can be a be pure or substantially pure. The itraconazole can be dry powder. In an aspect, the itraconazole can be an oint obtained from a bulk source. ment. The itraconazole can be pure or Substantially pure. The itraconazole can be obtained from a bulk source. In an aspect, the excipient base powder can comprise In an aspect, the excipient base powder can comprise LoxasperseTM excipient base powder. In an aspect, the 25 LoxasperseTM excipient base powder. In an aspect, the excipient base powder can comprise Loxasperse M excipient excipient base powder can comprise Loxasperse M excipient base powder and XyliFosTM excipient base powder. In an base powder and XyliFosTM excipient base powder. In an aspect, an excipient base powder can be obtained from a aspect, an excipient base powder can be obtained from a bulk source. bulk source. In an aspect, the anti-bacterial agent can comprise from 30 In an aspect, the mupirocin can comprise from about 10% about 10% to about 40% w/w of the compounded compo to about 40% w/w of the compounded composition. In an sition. In an aspect, the anti-bacterial agent can comprise aspect, the mupirocin can comprise from about 15% to about from about 15% to about 35% w/w of the compounded 35% w/w of the compounded composition. In an aspect, the composition. In an aspect, the anti-bacterial agent can com mupirocin can comprise from about 20% to about 30% w/w prise from about 20% to about 30% w/w of the compounded 35 of the compounded composition. In an aspect, the mupirocin composition. In an aspect, the anti-bacterial agent can com can comprise about 25% w/w of the compounded compo prise about 25% w/w of the compounded composition. sition. In an aspect, the itraconazole can comprise from about In an aspect, the itraconazole can comprise from about 10% to about 40% w/w of the compounded composition. In 40 10% to about 40% w/w of the compounded composition. In an aspect, the itraconazole can comprise from about 15% to an aspect, the itraconazole can comprise from about 15% to about 35% w/w of the compounded composition. In an about 35% w/w of the compounded composition. In an aspect, the itraconazole can comprise from about 20% to aspect, the itraconazole can comprise from about 20% to about 30% w/w of the compounded composition. In an about 30% w/w of the compounded composition. In an aspect, the itraconazole can comprise about 25% w/w of the 45 aspect, the itraconazole can comprise about 25% w/w of the compounded composition. compounded composition. In an aspect, the ratio of the anti-bacterial agent to the In an aspect, the ratio of the mupirocin to the itraconazole itraconazole in the compounded composition can be from in the compounded composition can be from about 1:4 to about 1:4 to about 4:1. In an aspect, the ratio of the about 4:1. In an aspect, the ratio of the mupirocin to the anti-bacterial agent to the itraconazole can be about 1:1. In 50 itraconazole can be about 1:1. In an aspect, the ratio of the an aspect, the ratio of the anti-bacterial agent to the itracon mupirocin to the itraconazole can be about 1.25:1. See, for azole can be about 1.25:1. See, e.g., Table 2. example, Table 2, which presents a representative, but not In an aspect, a disclosed compounded composition can exhaustive, listing of the '% w/w of mupirocin and itracon comprise one or more additional anti-infective agents. In an azole in a disclosed compounded composition. aspect, the additional anti-infective agent can be a dry 55 powder. In an aspect, the additional anti-infective agent can TABLE 2 be an ointment. The additional anti-infective agent can be REPRESENTATIVE LISTING OF MUPIROCIN pure or substantially pure. The additional anti-infective AND ITRACONAZOLE (% WW) INA agent can be obtained from a bulk source. In an aspect, the COMPOUNDED COMPOSITION additional anti-infective agent can be an anti-bacterial agent. 60 Loxasperse Anti-bacterial agents are known to the art and discussed Mupirocin Itraconazole and/or Xylifos (%) Supra. In an aspect, the additional anti-infective agent can be an anti-fungal agent. Anti-fungal agents are known to the art 10 1O-40 qS 15 1O-40 qS and discussed Supra. 2O 1O-40 qS In an aspect, a disclosed compounded composition can 65 25 1O-40 qS comprise one or more excipients or additives. In an aspect, 30 1O-40 qS excipients or additives include, but are not limited to, the US 9,707,229 B2 29 30 TABLE 2-continued mupirocin can comprise from about 20% to about 30% w/w of the compounded composition. In an aspect, the mupirocin REPRESENTATIVE LISTING OF MUPIROCIN can comprise about 25% w/w of the compounded compo AND ITRACONAZOLE (% WW) INA sition. COMPOUNDED COMPOSITION In an aspect, the itraconazole can comprise from about Loxasperse 10% to about 40% w/w of the compounded composition. In Mupirocin Itraconazole and/or Xylifos (%) an aspect, the itraconazole can comprise from about 15% to 35 1O-40 qS about 35% w/w of the compounded composition. In an 40 1O-40 qS aspect, the itraconazole can comprise from about 20% to 1O-40 10 qS 10 about 30% w/w of the compounded composition. In an 1O-40 15 qS 1O-40 2O qS aspect, the itraconazole can comprise about 25% w/w of the 1O-40 25 qS compounded composition. 1O-40 30 qS In an aspect, the ratio of the mupirocin to the itraconazole 1O-40 35 qS in the compounded composition can be from about 1:4 to 1O-40 40 qS 15 10 10 8O about 4:1. In an aspect, the ratio of the mupirocin to the 15 15 70 itraconazole can be about 1:1. In an aspect, the ratio of the 2O 2O 60 mupirocinto the itraconazole can be about 1.25:1. See, e.g., 25 25 50 Table 2. 30 30 40 35 35 30 In an aspect, the additional anti-infective agent can be a 40 40 2O dry powder. In an aspect, the additional anti-infective agent can be an ointment. The additional anti-infective agent can be pure or substantially pure. The additional anti-infective In an aspect, a disclosed compounded composition can agent can be obtained from a bulk source. In an aspect, the comprise one or more additional anti-infective agents. In an additional anti-infective agent can be an anti-bacterial agent. aspect, the additional anti-infective agent can be a dry 25 Anti-bacterial agents are known to the art and discussed powder. In an aspect, the additional anti-infective agent can Supra. In an aspect, the additional anti-infective agent can be be an ointment. The additional anti-infective agent can be an anti-fungal agent. Anti-fungal agents are known to the art pure or substantially pure. The additional anti-infective and discussed Supra. agent can be obtained from a bulk source. In an aspect, the In an aspect, a disclosed compounded composition can additional anti-infective agent can be an anti-bacterial agent. 30 comprise one or more excipients or additives. In an aspect, Anti-bacterial agents are known to the art and discussed excipients or additives include, but are not limited to, the supra. In an aspect, the additional anti-infective agent can be following: solvents, surfactants, humectants, preservatives, an anti-fungal agent. Anti-fungal agents are known to the art flavorings, stabilizers (including antioxidants), binders, and and discussed Supra. colorants. In an aspect, a disclosed compounded composition can 35 In an aspect, a disclosed compounded composition com comprise one or more excipients or additives. In an aspect, prising mupirocin, itraconazole, and at least one additional excipients or additives include, but are not limited to, the anti-infective agent can be encapsulated in one or more following: solvents, Surfactants, humectants, preservatives, capsules. The art is familiar with capsules, methods of flavorings, stabilizers (including antioxidants), binders, and making capsules, and methods of using capsules to encap colorants. 40 Sulate one or more disclosed compositions or one or more In an aspect, a disclosed compounded composition com disclosed agents. prising mupirocin and itraconazole can be encapsulated in 5. Compounded Composition Comprising Azithromycin and one or more capsules. The art is familiar with capsules, an Anti-Fungal Agent methods of making capsules, and methods of using capsules Disclosed herein is a compounded composition compris to encapsulate one or more disclosed compositions or one or 45 ing azithromycin, an anti-fungal agent, and an excipient base more disclosed agents. powder comprising a blend of micronized Xylitol and poloX Disclosed herein is a compounded composition compris aS. ing mupirocin, itraconazole, an excipient base powder com In an aspect, the compounded composition can be a dry prising a blend of micronized Xylitol and poloxamers, and at powder formulation. least one additional anti-infective agent. 50 In an aspect, the azithromycin can be a dry powder. In an In an aspect, the compounded composition can be a dry aspect, the azithromycin can be an ointment. The azithro powder formulation. mycin can be pure or Substantially pure. The azithromycin In an aspect, the mupirocin can be obtained from a bulk can be obtained from a bulk source. In an aspect, the Source. The mupirocin can be pure or Substantially pure. In anti-fungal agent can be a dry powder. In an aspect, the an aspect, the mupirocin can be an ointment. In an aspect, 55 anti-fungal agent can be an ointment. The anti-fungal agent the itraconazole can be obtained from a bulk source. In an can be pure or Substantially pure. The anti-fungal agent can aspect, the itraconazole can be an ointment. The itraconazole be obtained from a bulk source. can be pure or Substantially pure. In an aspect, the excipient In an aspect, the excipient base powder can comprise base powder can comprise LoxasperseTM excipient base LoxasperseTM excipient base powder. In an aspect, the powder. In an aspect, the excipient base powder can com 60 excipient base powder can comprise Loxasperse M excipient prise LoxasperseTM excipient base powder and XyliFosTM base powder and XyliFosTM excipient base powder. In an excipient base powder. In an aspect, an excipient base aspect, an excipient base powder can be obtained from a powder can be obtained from a bulk source. bulk source. In an aspect, the mupirocin can comprise from about 10% In an aspect, the azithromycin can comprise from about to about 40% w/w of the compounded composition. In an 65 10% to about 60% w/w of the compounded composition. In aspect, the mupirocin can comprise from about 15% to about an aspect, the azithromycin can comprise from about 20% to 35% w/w of the compounded composition. In an aspect, the about 50% w/w of the compounded composition. In an US 9,707,229 B2 31 32 aspect, the azithromycin can comprise from about 30% to In an aspect, the compounded composition can be a dry about 40% w/w of the compounded composition. In an powder formulation. aspect, the azithromycin can comprise about 25% w/w of the In an aspect, the anti-bacterial agent can be a dry powder. compounded composition. In an aspect, the azithromycin In an aspect, the anti-bacterial agent can be an ointment. The can comprise about 50% w/w of the compounded compo anti-bacterial agent can be pure or Substantially pure. The sition. anti-bacterial agent can be obtained from a bulk source. In In an aspect, the anti-fungal agent can comprise from an aspect, the fluconazole can be a dry powder. In an aspect, about 10% to about 60% w/w of the compounded compo the fluconazole can be an ointment. The fluconazole can be sition. In an aspect, the anti-fungal agent can comprise from pure or substantially pure. The fluconazole can be obtained 10 from a bulk source. about 20% to about 50% w/w of the compounded compo In an aspect, the excipient base powder can comprise sition. In an aspect, the anti-fungal agent can comprise from LoxasperseTM excipient base powder. In an aspect, the about 30% to about 40% w/w of the compounded compo excipient base powder can comprise Loxasperse M excipient sition. In an aspect, the anti-fungal agent can comprise about base powder and XyliFosTM excipient base powder. In an 25% w/w of the compounded composition. In an aspect, the 15 aspect, an excipient base powder can be obtained from a anti-fungal agent can comprise about 50% w/w of the bulk source. compounded composition. In an aspect, the anti-bacterial agent can comprise from In an aspect, the ratio of the azithromycin to the anti about 10% to about 60% w/w of the compounded compo fungal agent in the compounded composition can be from sition. In an aspect, the anti-bacterial agent can comprise about 1:4 to about 4:1. In an aspect, the ratio of the from about 20% to about 50% w/w of the compounded azithromycinto the anti-fungal agent can be about 1:1. In an composition. In an aspect, the anti-bacterial agent can com aspect, the ratio of the azithromycin to the anti-fungal agent prise from about 30% to about 40% w/w of the compounded can be about 1.25:1. composition. In an aspect, the anti-bacterial agent can com In an aspect, anti-fungal agent can comprise abafungin, prise about 25% w/w of the compounded composition. In an albaconazole, amorolfin, amphotericin b, anidulafungin, 25 aspect, the anti-bacterial agent can comprise about 50% w/w bifonazole, butenafine, butoconazole, candicidin, caspo of the compounded composition. fungin, ciclopirox, clotrimazole, econazole, fenticonazole, In an aspect, the fluconazole agent can comprise from filipin, fluconazole, flucytosine, griseofulvin, haloprogin, about 10% to about 60% w/w of the compounded compo hamycin, isavuconazole, isoconazole, itraconazole, keto sition. In an aspect, the fluconazole can comprise from about conazole, micafungin, miconazole, naftifine, natamycin, 30 20% to about 50% w/w of the compounded composition. In nystatin, omoconazole, oxiconazole, polygodial, posacon an aspect, the fluconazole can comprise from about 30% to azole, raVuconazole, rimocidin, sertaconazole, sulconazole, about 40% w/w of the compounded composition. In an terbinafine, terconazole, tioconazole, tolnaftate, undecylenic aspect, the fluconazole can comprise about 25% w/w of the acid, Voriconazole, or a combination thereof. compounded composition. In an aspect, the fluconazole can In an aspect, the anti-fungal agent can comprise flucon 35 comprise about 50% w/w of the compounded composition. azole. In an aspect, the ratio of the anti-bacterial agent to the In an aspect, a disclosed compounded composition com fluconazole in the compounded composition can be from prising azithromycin and an anti-fungal agent can comprise about 1:4 to about 4:1. In an aspect, the ratio of the one or more additional anti-infective agents. In an aspect, anti-bacterial agent to the fluconazole can be about 1:1. In an the additional anti-infective agent can be a dry powder. In an 40 aspect, the ratio of the anti-bacterial agent to the fluconazole aspect, the additional anti-infective agent can be an oint can be about 1.25:1. ment. The additional anti-infective agent can be pure or In an aspect, the anti-bacterial agent can comprise Substantially pure. The additional anti-infective agent can be afenide, amikacin, amoxicillin, amplicillin, arsphenamine, obtained from a bulk source. In an aspect, the additional azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra anti-infective agent can be an anti-bacterial agent. Anti 45 cin, carbacephem (loracarbef), carbenicillin, cefaclor, bacterial agents are known to the art and discussed Supra. In cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi an aspect, the additional anti-infective agent can be an toren, cefepime, cefixime, cefoperaZone, cefotaxime, anti-fungal agent. Anti-fungal agents are known to the art cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, and discussed Supra. ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha In an aspect, a disclosed compounded composition can 50 lexin, chloramphenicol, chlorhexidine, ciprofloxacin, comprise one or more excipients or additives. In an aspect, clarithromycin, clavulanic acid, clindamycin, cloxacillin, excipients or additives include, but are not limited to, the colimycin, colistimethate teicoplanin, colistin, demeclocy following: solvents, Surfactants, humectants, preservatives, cline, dicloxacillin, dirithromycin, doripenem, doxycycline, flavorings, stabilizers (including antioxidants), binders, and efprozil, enoxacin, ertapenem, erythromycin, ethambutol, colorants. 55 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, In an aspect, a disclosed compounded composition com geldanamycin, gentamicin, grepafloxacin, herbimycin, imi prising azithromycin and an anti-fungal agent can be encap penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin sulated in one or more capsules. The art is familiar with eZolid, lomefloxacin, meropenem, meticillin, metronidazole, capsules, methods of making capsules, and methods of using meZlocillin, minocycline, mitomycin, moxifloxacin, mupi capsules to encapsulate one or more disclosed compositions 60 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor or one or more disclosed agents. floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy 6. Compounded Composition Comprising an Anti-Bacterial cin, penicillin G, penicillin V, piperacillin, pivmecillinam, Agent and Fluconazole platensimycin, polymyxin B, prontosil, pvampicillin, Disclosed herein is a compounded composition compris pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam ing an anti-bacterial agent, fluconazole, and an excipient 65 pin, roXithromycin, sparfloxacin, spectinomycin, spiramy base powder comprising a blend of micronized Xylitol and cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox poloxamers. azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, US 9,707,229 B2 33 34 Sultamicillin, tellithromycin, tetracycline, thiamphenicol, about 40% w/w of the compounded composition. In an ticarcillin, tobramycin, trimethoprim, trimethoprim-sul aspect, the fluconazole can comprise about 25% w/w of the famethoxazole, troleandomycin, trovafloxacin, or a combi compounded composition. In an aspect, the fluconazole can nation thereof. comprise about 50% w/w of the compounded composition. In an aspect, the anti-bacterial agent can comprise azithro In an aspect, the ratio of the azithromycin to the flucon mycin. azole in the compounded composition can be from about 1:4 In an aspect, a disclosed compounded composition com to about 4:1. In an aspect, the ratio of the azithromycinto the prising an anti-bacterial agent and fluconazole can comprise fluconazole can be about 1:1. In an aspect, the ratio of the one or more additional anti-infective agents. In an aspect, azithromycin to the fluconazole can be about 1.25:1. See, the additional anti-infective agent can be a dry powder. In an 10 aspect, the additional anti-infective agent can be an oint e.g., Table 3 which presents a representative, but not exhaus ment. The additional anti-infective agent can be pure or tive, listing of the '% w/w of azithromycin to fluconazole in Substantially pure. The additional anti-infective agent can be a disclosed compounded composition. obtained from a bulk source. In an aspect, the additional TABLE 3 anti-infective agent can be an anti-bacterial agent. Anti 15 bacterial agents are known to the art and discussed Supra. In REPRESENTATIVE LISTING an aspect, the additional anti-infective agent can be an OF AZITHROMYCIN AND anti-fungal agent. Anti-fungal agents are known to the art FLUCONAZOLE (% WW) INA and discussed Supra. COMPOUNDED COMPOSITION In an aspect, a disclosed compounded composition can Loxasperse comprise one or more excipients or additives. In an aspect, Azithromycin Fluconazole and/or Xylifos (%) excipients or additives include, but are not limited to, the 10 1O-40 qS following: solvents, Surfactants, humectants, preservatives, 15 1O-40 qS flavorings, stabilizers (including antioxidants), binders, and 2O 1O-40 qS colorants. 25 25 1O-40 qS 30 1O-40 qS In an aspect, a disclosed compounded composition com 35 1O-40 qS prising an anti-bacterial agent and fluconazole can be encap 40 1O-40 qS sulated in one or more capsules. The art is familiar with 1O-40 10 qS capsules, methods of making capsules, and methods of using 1O-40 15 qS 30 1O-40 2O qS capsules to encapsulate one or more disclosed compositions 1O-40 25 qS or one or more disclosed agents. 1O-40 30 qS 7. Compounded Composition Comprising Azithromycin and 1O-40 35 qS Fluconazole 1O-40 40 qS Disclosed herein is a compounded composition compris 10 10 8O 15 15 70 ing azithromycin, fluconazole, and an excipient base powder 35 2O 2O 60 comprising a blend of micronized Xylitol and poloxamers. 25 25 50 In an aspect, the compounded composition can be a dry 30 30 40 powder formulation. 35 35 30 In an aspect, the azithromycin can be a dry powder. In an 40 40 2O aspect, the azithromycin can be an ointment. The azithro 40 mycin can be pure or Substantially pure. The azithromycin In an aspect, the compounded composition comprising can be obtained from a bulk source. In an aspect, the azithromycin and fluconazole can comprise at least one fluconazole can be a dry powder. In an aspect, the flucon additional anti-infective agent. In an aspect, the additional azole can be an ointment. The fluconazole can be pure or anti-infective agent can be a dry powder. In an aspect, the substantially pure. The fluconazole can be obtained from a 45 additional anti-infective agent can be an ointment. The bulk source. additional anti-infective agent can be pure or Substantially In an aspect, the excipient base powder can comprise pure. The additional anti-infective agent can be obtained LoxasperseTM excipient base powder. In an aspect, the from a bulk source. In an aspect, the additional anti-infective excipient base powder can comprise Loxasperse M excipient agent can be an anti-bacterial agent. Anti-bacterial agents are base powder and XyliFosTM excipient base powder. In an 50 aspect, an excipient base powder can be obtained from a known to the art and discussed Supra. In an aspect, the bulk source. additional anti-infective agent can be an anti-fungal agent. In an aspect, the azithromycin can comprise from about Anti-fungal agents are known to the art and discussed Supra. 10% to about 60% w/w of the compounded composition. In In an aspect, a disclosed compounded composition can an aspect, the azithromycin can comprise from about 20% to 55 comprise one or more excipients or additives. In an aspect, about 50% w/w of the compounded composition. In an excipients or additives include, but are not limited to, the aspect, the azithromycin can comprise from about 30% to following: solvents, Surfactants, humectants, preservatives, about 40% w/w of the compounded composition. In an flavorings, stabilizers (including antioxidants), binders, and aspect, the azithromycin can comprise about 25% w/w of the colorants. compounded composition. In an aspect, the azithromycin 60 In an aspect, a disclosed compounded composition com can comprise about 50% w/w of the compounded compo prising azithromycin and fluconazole can be encapsulated in sition. one or more capsules. The art is familiar with capsules, In an aspect, the fluconazole can comprise from about methods of making capsules, and methods of using capsules 10% to about 60% w/w of the compounded composition. In to encapsulate one or more disclosed compositions or one or an aspect, the fluconazole can comprise from about 20% to 65 more disclosed agents. about 50% w/w of the compounded composition. In an Disclosed herein is a compounded composition compris aspect, the fluconazole can comprise from about 30% to ing azithromycin, fluconazole, an excipient base powder US 9,707,229 B2 35 36 comprising a blend of micronized Xylitol and poloxamers, 8. Compounded Composition Comprising Mupirocin and and at least one additional anti-infective agent. Nystatin In an aspect, the compounded composition can be a dry Disclosed herein can be a compounded composition com powder formulation. prising mupirocin, nystatin, and an excipient base powder In an aspect, the azithromycin can be a dry powder. In an comprising a blend of micronized Xylitol and poloxamers. aspect, the azithromycin can be an ointment. The azithro In an aspect, the compounded composition can be a dry mycin can be pure or Substantially pure. The azithromycin powder formulation. can be obtained from a bulk source. In an aspect, the In an aspect, the mupirocin can be obtained from a bulk fluconazole can be a dry powder. In an aspect, the flucon Source. The mupirocin can be pure or Substantially pure. In azole can be an ointment. The fluconazole can be pure or 10 an aspect, the mupirocin can be a dry powder. In an aspect, substantially pure. The fluconazole can be obtained from a the mupirocin can be an ointment. In an aspect, the mupi bulk source. rocin can be a 2% ointment. In an aspect, the mupirocin can In an aspect, the excipient base powder can comprise be provided in a tube. For example, in an aspect, the LoxasperseTM excipient base powder. In an aspect, the 15 mupirocin can be provided in a 22 gram tube. In an aspect, excipient base powder can comprise Loxasperse M excipient the nystatin can be obtained from a bulk source. The nystatin base powder and XyliFosTM excipient base powder. In an can be pure or Substantially pure. In an aspect, the nystatin aspect, an excipient base powder can be obtained from a can be a dry powder. In an aspect, the nystatin can be an bulk source. ointment. In an aspect, the nystatin can be provided in a In an aspect, the azithromycin can comprise from about container. For example, in an aspect, the nystatin can be 10% to about 60% w/w of the compounded composition. In provided in 15 gram container. an aspect, the azithromycin can comprise from about 20% to In an aspect, the excipient base powder can comprise about 50% w/w of the compounded composition. In an LoxasperseTM excipient base powder. In an aspect, the aspect, the azithromycin can comprise from about 30% to excipient base powder can comprise Loxasperse M excipient about 40% w/w of the compounded composition. In an 25 base powder and XyliFosTM excipient base powder. In an aspect, the azithromycin can comprise about 25% w/w of the aspect, an excipient base powder can be obtained from a compounded composition. In an aspect, the azithromycin bulk source. can comprise about 50% w/w of the compounded compo In an aspect, the mupirocin can comprise from about 10% sition. to about 40% w/w of the compounded composition. In an In an aspect, the fluconazole can comprise from about 30 aspect, the mupirocin can comprise from about 15% to about 10% to about 60% w/w of the compounded composition. In 35% w/w of the compounded composition. In an aspect, the an aspect, the fluconazole can comprise from about 20% to mupirocin can comprise from about 20% to about 30% w/w about 50% w/w of the compounded composition. In an of the compounded composition. In an aspect, the mupirocin aspect, the fluconazole can comprise from about 30% to can comprise about 25% w/w of the compounded compo about 40% w/w of the compounded composition. In an 35 sition. aspect, the fluconazole can comprise about 25% w/w of the In an aspect, the nystatin can comprise from about 10% to compounded composition. In an aspect, the fluconazole can about 40% w/w of the compounded composition. In an comprise about 50% w/w of the compounded composition. aspect, the nyStatin can comprise from about 15% to about In an aspect, the ratio of the azithromycin to fluconazole 35% w/w of the compounded composition. In an aspect, the in the compounded composition can be from about 1:4 to 40 nystatin can comprise from about 20% to about 30% w/w of about 4:1. In an aspect, the ratio of the azithromycin to the the compounded composition. In an aspect, the nystatin can fluconazole can be about 1:1. In an aspect, the ratio of the comprise about 25% w/w of the compounded composition. azithromycin to the fluconazole can be about 1.25:1. See, In an aspect, the ratio of the mupirocinto the nyStatin in the e.g., Table 3. compounded composition can be from about 1:4 to about In an aspect, the additional anti-infective agent can be a 45 4:1. In an aspect, the ratio of the mupirocin to the nystatin dry powder. In an aspect, the additional anti-infective agent can be about 1:1 or the ratio can be about 1.5:1. can be an ointment. The additional anti-infective agent can In an aspect, a disclosed compounded composition can be pure or substantially pure. The additional anti-infective comprise one or more additional anti-infective agents. In an agent can be obtained from a bulk source. In an aspect, the aspect, the additional anti-infective agent can be a dry additional anti-infective agent can be an anti-bacterial agent. 50 powder. In an aspect, the additional anti-infective agent can Anti-bacterial agents are known to the art and discussed be an ointment. The additional anti-infective agent can be Supra. In an aspect, the additional anti-infective agent can be pure or substantially pure. The additional anti-infective an anti-fungal agent. Anti-fungal agents are known to the art agent can be obtained from a bulk source. In an aspect, the and discussed Supra. additional anti-infective agent can be an anti-bacterial agent. In an aspect, a disclosed compounded composition can 55 Anti-bacterial agents are known to the art and discussed comprise one or more excipients or additives. In an aspect, Supra. In an aspect, the additional anti-infective agent can be excipients or additives include, but are not limited to, the an anti-fungal agent. Anti-fungal agents are known to the art following: solvents, Surfactants, humectants, preservatives, and discussed Supra. flavorings, stabilizers (including antioxidants), binders, and In an aspect, a disclosed compounded composition can colorants. 60 comprise one or more excipients or additives. In an aspect, In an aspect, a disclosed compounded composition com excipients or additives include, but are not limited to, the prising azithromycin, fluconazole, and at least one additional following: solvents, Surfactants, humectants, preservatives, anti-infective agent can be encapsulated in one or more flavorings, stabilizers (including antioxidants), binders, and capsules. The art is familiar with capsules, methods of colorants. making capsules, and methods of using capsules to encap 65 In an aspect, a disclosed compounded composition com Sulate one or more disclosed compositions or one or more prising mupirocin and nystatin can be encapsulated in one or disclosed agents. more capsules. The art is familiar with capsules, methods of US 9,707,229 B2 37 38 making capsules, and methods of using capsules to encap lexin, chloramphenicol, chlorhexidine, ciprofloxacin, Sulate one or more disclosed compositions or one or more clarithromycin, clavulanic acid, clindamycin, cloxacillin, disclosed agents. colimycin, colistimethate teicoplanin, colistin, demeclocy C. Capsules cline, dicloxacillin, dirithromycin, doripenem, doxycycline, 1. Capsules Comprising a Compounded Composition efprozil, enoxacin, ertapenem, erythromycin, ethambutol, Disclosed herein is a capsule comprising a disclosed flucloxacillin, fosfomycin, furazolidone, gatifloxacin, compounded composition. geldanamycin, gentamicin, grepafloxacin, herbimycin, imi Disclosed herein is a capsule comprising a compounded penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin composition, wherein the compounded composition com eZolid, lomefloxacin, meropenem, meticillin, metronidazole, prises an anti-bacterial agent and an anti-fungal agent. 10 meZlocillin, minocycline, mitomycin, moxifloxacin, mupi Disclosed herein is a capsule comprising a compounded rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor composition, wherein the compounded composition com floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy prises an anti-bacterial agent, an anti-fungal agent, and cin, penicillin G, penicillin V, piperacillin, pivmecillinam, LoxasperseTM excipient base powder. platensimycin, polymyxin B, prontosil, pvampicillin, Disclosed herein is a capsule comprising a compounded 15 pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam composition, wherein the compounded composition com pin, roXithromycin, sparfloxacin, spectinomycin, spiramy prises an anti-bacterial agent, an anti-fungal agent, and an cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox excipient base powder comprising a blend of micronized azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, Xylitol and poloxamers. Sultamicillin, tellithromycin, tetracycline, thiamphenicol, In an aspect, the encapsulated compounded composition ticarcillin, tobramycin, trimethoprim, trimethoprim-sul can be a dry powder formulation. In an aspect, the anti famethoxazole, troleandomycin, trovafloxacin, or a combi bacterial agent can be a dry powder. In an aspect, the nation thereof. anti-bacterial agent can be an ointment. The anti-bacterial In an aspect, the anti-bacterial agent of a disclosed encap agent can be pure or Substantially pure. The anti-bacterial Sulated compounded composition can comprise mupirocin. agent can be obtained from a bulk source. In an aspect, the 25 In an aspect, the anti-bacterial agent of a disclosed encap anti-fungal agent can be a dry powder. In an aspect, the Sulated compounded composition can comprise azithromy anti-fungal agent can be an ointment. The anti-fungal agent cin. can be pure or Substantially pure. The anti-fungal agent can In an aspect, the anti-fungal agent can comprise aba be obtained from a bulk source. In an aspect, the excipient fungin, albaconazole, amorolfin, amphotericin b, anidula base powder can comprise LoxasperseTM excipient base 30 fungin, bifonazole, butenafine, butoconazole, candicidin, powder. In an aspect, the excipient base powder can com caspofungin, ciclopiroX, clotrimazole, econazole, fenticon prise LoxasperseTM excipient base powder and XyliFosTM azole, filipin, fluconazole, flucytosine, griseofulvin, halo excipient base powder. In an aspect, an excipient base progin, hamycin, isavuconazole, isoconazole, itraconazole, powder can be obtained from a bulk source. ketoconazole, micafungin, miconazole, naftifine, natamycin, In an aspect, the anti-bacterial agent can comprise from 35 nystatin, omoconazole, oxiconazole, polygodial, posacon about 10% to about 40% w/w of the encapsulated com azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, pounded composition. In an aspect, the anti-bacterial agent terbinafine, terconazole, tioconazole, tolnaftate, undecylenic can comprise from about 15% to about 35% w/w of the acid, Voriconazole, or a combination thereof. encapsulated compounded composition. In an aspect, the In an aspect, a disclosed encapsulated compounded com anti-bacterial agent can comprise from about 20% to about 40 position can comprise itraconazole. In an aspect, a disclosed 30% w/w of the encapsulated compounded composition. In encapsulated compounded composition can comprise flu an aspect, the anti-bacterial agent can comprise about 25% conazole. In an aspect, a disclosed encapsulated com W/w of the encapsulated compounded composition. pounded composition can comprise nystatin. In an aspect, the anti-fungal agent can comprise from In an aspect, a disclosed encapsulated compounded com about 10% to about 40% w/w of the encapsulated com 45 position can comprise mupirocin and itraconazole. In an pounded composition. In an aspect, the anti-fungal agent can aspect, a disclosed encapsulated compounded composition comprise from about 15% to about 35% w/w of the encap can comprise azithromycin and fluconazole. In an aspect, a Sulated compounded composition. In an aspect, the anti disclosed encapsulated compounded composition can com fungal agent can comprise from about 20% to about 30% prise mupirocin and nystatin. W/w of the encapsulated compounded composition. In an 50 In an aspect, a disclosed capsule can comprise about 100 aspect, the anti-fungal agent can comprise about 25% w/w mg to about 2000 mg of a compounded composition. For of the encapsulated compounded composition. example, in an aspect, a disclosed capsule can comprise In an aspect, the ratio of the anti-bacterial agent to the about 100 mg, about 150 mg, about 200 mg, about 250 mg. anti-fungal agent in the encapsulated compounded compo about 300 mg, about 350 mg, about 400 mg, about 450 mg. sition can be from about 1:4 to about 4:1. In an aspect, the 55 about 500 mg, about 550 mg, about 600 mg, about 650 mg. ratio of the anti-bacterial agent to the anti-fungal agent can about 700 mg, about 750, about 800 mg, about 850 mg. be about 1:1. In an aspect, the ratio of the anti-bacterial agent about 900 mg, about 950 mg, about 1000 mg, about 1050 to the anti-fungal agent can be about 1.25:1. See, e.g., Table mg, about 1100 mg, about 1150 mg, about 1200 mg, about 1. 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg. In an aspect, the anti-bacterial agent can comprise 60 about 1450 mg, about 1500 mg, about 1550 mg, about 1600 afenide, amikacin, amoxicillin, amplicillin, arsphenamine, mg, about 1650 mg, about 1700 mg, about 1750 mg, about azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg. cin, carbacephem (loracarbef), carbenicillin, cefaclor, or about 2000 mg of a disclosed compounded composition. cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi In an aspect, a disclosed encapsulated compounded com toren, cefepime, cefixime, cefoperaZone, cefotaxime, 65 position can comprise one or more additional anti-infective cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, agents. In an aspect, the additional anti-infective agent can ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha be a dry powder. In an aspect, the additional anti-infective US 9,707,229 B2 39 40 agent can be an ointment. The additional anti-infective agent ized Xylitol and poloxamers. Disclosed herein is a capsule can be pure or Substantially pure. The additional anti comprising a compounded composition comprising mupi infective agent can be obtained from a bulk source. In an rocin, nystatin, and an excipient base powder comprising a aspect, the additional anti-infective agent can be an anti blend of micronized xylitol and poloxamers. Disclosed bacterial agent. Anti-bacterial agents are known to the art herein is a capsule comprising a compounded composition and discussed Supra. In an aspect, the additional anti comprising mupirocin, nystatin, an excipient base powder infective agent can be an anti-fungal agent. Anti-fungal comprising a blend of micronized Xylitol and poloxamers, agents are known to the art and discussed Supra. and at least one additional anti-infective agent. Disclosed In an aspect, a disclosed encapsulated compounded com herein is a capsule comprising a compounded composition position can comprise one or more excipients or additives. 10 comprising mupirocin, nystatin, and Loxasperse M excipient In an aspect, excipients or additives include, but are not base powder. limited to, the following: solvents, Surfactants, humectants, 1. Capsules Comprising an Anti-Bacterial Agent preservatives, flavorings, stabilizers (including antioxi Disclosed herein is a capsule comprising an anti-bacterial dants), binders, and colorants. agent. a. Mupirocin and/or Itraconazole 15 In an aspect, the anti-bacterial agent can be a dry powder. Disclosed herein is a capsule comprising a compounded In an aspect, the anti-bacterial agent can be an ointment. The composition, wherein the compounded composition com anti-bacterial agent can be pure or Substantially pure. The prises mupirocin and itraconazole. Disclosed herein is a anti-bacterial agent can be obtained from a bulk source. capsule comprising a compounded composition comprising In an aspect, a disclosed capsule can comprise an excipi mupirocin, an anti-fungal agent, and an excipient base ent base powder comprising a blend of micronized Xylitol powder comprising a blend of micronized Xylitol and poloX and poloxamers. In an aspect, the excipient base powder can amers. Disclosed herein is a capsule comprising a com comprise Loxasperse M excipient base powder. In an aspect, pounded composition comprising an anti-bacterial agent, the excipient base powder can comprise LoxasperseTM itraconazole, and an excipient base powder comprising a excipient base powder and XyliFosTM excipient base pow blend of micronized xylitol and poloxamers. Disclosed 25 der. In an aspect, an excipient base powder can be obtained herein is a capsule comprising a compounded composition from a bulk source. comprising mupirocin, itraconazole, and an excipient base In an aspect, the anti-bacterial agent can comprise powder comprising a blend of micronized Xylitol and poloX afenide, amikacin, amoxicillin, amplicillin, arsphenamine, amers. Disclosed herein is a capsule comprising a com azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra pounded composition comprising mupirocin, itraconazole, 30 cin, carbacephem (loracarbef), carbenicillin, cefaclor, an excipient base powder comprising a blend of micronized cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi xylitol and poloxamers, and at least one additional anti toren, cefepime, cefixime, cefoperazone, cefotaxime, infective agent. Disclosed herein is a capsule comprising a cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, compounded composition comprising mupirocin, itracon ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha azole, and LoxasperseTM excipient base powder. 35 lexin, chloramphenicol, chlorhexidine, ciprofloxacin, b. Azithromycin and/or Fluconazole clarithromycin, clavulanic acid, clindamycin, cloxacillin, Disclosed herein is a capsule comprising a compounded colimycin, colistimethate teicoplanin, colistin, demeclocy composition, wherein the compounded composition com cline, dicloxacillin, dirithromycin, doripenem, doxycycline, prises azithromycin and fluconazole. Disclosed herein is a efprozil, enoxacin, ertapenem, erythromycin, ethambutol, capsule comprising a compounded composition comprising 40 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, azithromycin, an anti-fungal agent, and an excipient base geldanamycin, gentamicin, grepafloxacin, herbimycin, imi powder comprising a blend of micronized Xylitol and poloX penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin amers. Disclosed herein is a capsule comprising a com eZolid, lomefloxacin, meropenem, meticillin, metronidazole, pounded composition comprising an anti-bacterial agent, meZlocillin, minocycline, mitomycin, moxifloxacin, mupi fluconazole, and an excipient base powder comprising a 45 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor blend of micronized xylitol and poloxamers. Disclosed floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy herein is a capsule comprising a compounded composition cin, penicillin G, penicillin V, piperacillin, pivmecillinam, comprising azithromycin, fluconazole, and an excipient base platensimycin, polymyxin B, prontosil, pvampicillin, powder comprising a blend of micronized Xylitol and poloX pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam amers. Disclosed herein is a capsule comprising a com 50 pin, roXithromycin, sparfloxacin, spectinomycin, spiramy pounded composition comprising azithromycin, flucon cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox azole, an excipient base powder comprising a blend of azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, micronized Xylitol and poloxamers, and at least one addi Sultamicillin, tellithromycin, tetracycline, thiamphenicol, tional anti-infective agent. Disclosed herein is a capsule ticarcillin, tobramycin, trimethoprim, trimethoprim-sul comprising a compounded composition comprising azithro 55 famethoxazole, troleandomycin, trovafloxacin, or a combi mycin, fluconazole, and Loxasperse M excipient base pow nation thereof. der. In an aspect, a disclosed capsule can comprise mupirocin. c. Mupirocin and/or Nystatin In an aspect, a disclosed capsule can comprise azithromycin. Disclosed herein is a capsule comprising a compounded In an aspect, a disclosed capsule can comprise about 100 composition, wherein the compounded composition com 60 mg to about 2000 mg or a disclosed anti-bacterial agent. For prises mupirocin and nystatin. Disclosed herein is a capsule example, in an aspect, a disclosed capsule can comprise comprising a compounded composition comprising mupi about 100 mg, about 150 mg, about 200 mg, about 250 mg. rocin, an anti-fungal agent, and an excipient base powder about 300 mg, about 350 mg, about 400 mg, about 450 mg. comprising a blend of micronized Xylitol and poloxamers. about 500 mg, about 550 mg, about 600 mg, about 650 mg. Disclosed herein is a capsule comprising a compounded 65 about 700 mg, about 750, about 800 mg, about 850 mg. composition comprising an anti-bacterial agent, nystatin, about 900 mg, about 950 mg, about 1000 mg, about 1050 and an excipient base powder comprising a blend of micron mg, about 1100 mg, about 1150 mg, about 1200 mg, about US 9,707,229 B2 41 42 1250 mg, about 1300 mg, about 1350 mg, about 1400 mg. In an aspect, a disclosed capsule can comprise itracon about 1450 mg, about 1500 mg, about 1550 mg, about 1600 azole. In an aspect, a disclosed capsule can comprise flu mg, about 1650 mg, about 1700 mg, about 1750 mg, about conazole. In an aspect, a disclosed capsule can comprise 1800 mg, about 1850 mg, about 1900 mg, about 1950 mg. nystatin. or about 2000 mg of a disclosed anti-bacterial agent. For example, in an aspect, a disclosed capsule can com For example, in an aspect, a disclosed capsule can com prise about 100 mg to about 1000 mg of itraconazole. In an prise about 100 mg to about 1000 mg of mupirocin. In an aspect, a disclosed capsule can comprise about 100 mg of aspect, a disclosed capsule can comprise about 100 mg of itraconazole, about 150 mg of itraconazole, about 200 mg of mupirocin, about 150 mg of mupirocin, about 200 mg of itraconazole, about 250 mg of itraconazole, about 300 mg of mupirocin, about 250 mg of mupirocin, about 300 mg of 10 itraconazole, about 350 mg of itraconazole, about 400 mg of itraconazole, about 450 mg of itraconazole, about 500 mg of mupirocin, about 350 mg of mupirocin, about 400 mg of itraconazole, about 550 mg of itraconazole, about 600 mg of mupirocin, about 450 mg of mupirocin, about 500 mg of itraconazole, about 650 mg of itraconazole, about 700 mg of mupirocin, about 550 mg of mupirocin, about 600 mg of itraconazole, about 750 mg of itraconazole, about 800 mg of mupirocin, about 650 mg of mupirocin, about 700 mg of 15 itraconazole, about 850 mg of itraconazole, about 900 mg of mupirocin, about 750 mg of mupirocin, about 800 mg of itraconazole, about 950 mg of itraconazole, or about 1000 mupirocin, about 850 mg of mupirocin, about 900 mg of mg of itraconazole, or more of itraconazole. mupirocin, about 950 mg of mupirocin, or about 1000 mg of For example, in an aspect, a disclosed capsule can com mupirocin, or more of mupirocin. prise about 100 mg to about 1000 mg of fluconazole. In an For example, in an aspect, a disclosed capsule can com aspect, a disclosed capsule can comprise about 100 mg of prise about 100 mg to about 1000 mg of azithromycin. In an fluconazole, about 150 mg of fluconazole, about 200 mg of aspect, a disclosed capsule can comprise about 100 mg of fluconazole, about 250 mg of fluconazole, about 300 mg of azithromycin, about 150 mg of azithromycin, about 200 mg fluconazole, about 350 mg of fluconazole, about 400 mg of of azithromycin, about 250 mg of azithromycin, about 300 fluconazole, about 450 mg of fluconazole, about 500 mg of mg of azithromycin, about 350 mg of azithromycin, about 25 fluconazole, about 550 mg of fluconazole, about 600 mg of 400 mg of azithromycin, about 450 mg of azithromycin, fluconazole, about 650 mg of fluconazole, about 700 mg of about 500 mg of azithromycin, about 550 mg of azithromy fluconazole, about 750 mg of fluconazole, about 800 mg of cin, about 600 mg of azithromycin, about 650 mg of fluconazole, about 850 mg of fluconazole, about 900 mg of azithromycin, about 700 mg of azithromycin, about 750 mg fluconazole, about 950 mg of fluconazole, or about 1000 mg of azithromycin, about 800 mg of azithromycin, about 850 30 of fluconazole, or more of fluconazole. In an aspect, a mg of azithromycin, about 900 mg of azithromycin, about disclosed capsule can comprise about 200 mg of flucon 950 mg of azithromycin, or about 1000 mg of azithromycin, azole. or more of azithromycin. In an aspect, a disclosed capsule For example, in an aspect, a disclosed capsule can com can comprise about 250 mg of azithromycin. prise about 100 mg to about 1000 mg of nystatin. In an In an aspect, a disclosed capsule can comprise one or 35 aspect, a disclosed capsule can comprise about 100 mg of more excipients or additives. In an aspect, excipients or nystatin, about 150 mg of nystatin, about 200 mg of nystatin, additives include, but are not limited to, the following: about 250 mg of nystatin, about 300 mg of nystatin, about Solvents, Surfactants, humectants, preservatives, flavorings, 350 mg of nystatin, about 400 mg of nystatin, about 450 mg stabilizers (including antioxidants), binders, and colorants. of nystatin, about 500 mg of nystatin, about 550 mg of Disclosed herein is a capsule comprising mupirocin. 40 nystatin, about 600 mg of nystatin, about 650 mg of nystatin, Disclosed herein is a capsule comprising azithromycin. about 700 mg of nystatin, about 750 mg of nystatin, about 2. Capsules Comprising an Anti-Fungal Agent 800 mg of nystatin, about 850 mg of fluconazole, about 900 Disclosed herein is a capsule comprising an anti-fungal mg of nystatin, about 950 mg of nystatin, or about 1000 mg agent. In an aspect, the anti-fungal agent can be a dry of nystatin, or more of nystatin. powder. In an aspect, the anti-fungal agent can be an 45 In an aspect, a disclosed capsule can comprise one or ointment. The anti-fungal agent can be pure or Substantially more excipients or additives. In an aspect, excipients or pure. The anti-fungal agent can be obtained from a bulk additives include, but are not limited to, the following: SOUC. Solvents, Surfactants, humectants, preservatives, flavorings, In an aspect, a disclosed capsule can comprise an excipi stabilizers (including antioxidants), binders, and colorants. ent base powder comprising a blend of micronized Xylitol 50 Disclosed herein is a capsule comprising itraconazole. and poloxamers. In an aspect, the excipient base powder can Disclosed herein is a capsule comprising fluconazole. Dis comprise Loxasperse M excipient base powder. In an aspect, closed herein is a capsule comprising nyStatin. the excipient base powder can comprise LoxasperseTM B. Containers excipient base powder and XyliFosTM excipient base pow 1. Containers Comprising a Compounded Composition der. In an aspect, an excipient base powder can be obtained 55 Disclosed herein is a container comprising a disclosed from a bulk source. compounded composition. In an aspect, the anti-fungal agent can comprise aba Disclosed herein is a container comprising a compounded fungin, albaconazole, amorolfin, amphotericin b, anidula composition, wherein the compounded composition can fungin, bifonazole, butenafine, butoconazole, candicidin, comprise an anti-bacterial agent, an anti-fungal agent, and caspofungin, ciclopiroX, clotrimazole, econazole, fenticon 60 an excipient base powder comprising a blend of micronized azole, filipin, fluconazole, flucytosine, griseofulvin, halo Xylitol and poloxamers. progin, hamycin, isavuconazole, isoconazole, itraconazole, In an aspect, the container can be a glass container and can ketoconazole, micafungin, miconazole, naftifine, natamycin, comprise a stopper or a seal. In an aspect, the container can nystatin, omoconazole, oxiconazole, polygodial, posacon be a non-glass container and can comprise a stopper or a azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, 65 seal. The stopper can comprise siliconized or non-sili terbinafine, terconazole, tioconazole, tolnaftate, undecylenic conized rubber. The stopper or seal can comprise metal. The acid, Voriconazole, or a combination thereof. stopper or seal can comprise a Teflon coating or a Teflon US 9,707,229 B2 43 44 treatment. In an aspect, the container can be a disposable ime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, cefto packet. The disposable packet can be moisture free. In an biprole, ceftriaxone, cefuroxime, cephalexin, chlorampheni aspect, the container can be a glass or non-glass vial. col, chlorhexidine, ciprofloxacin, clarithromycin, clavulanic In an aspect, a container can hold or accommodate about acid, clindamycin, cloxacillin, colimycin, colistimethate tei 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 coplanin, colistin, demeclocycline, dicloxacillin, dirithro mL, 150 mL, 175 mL, 200 mL, 250 mL, 300 mL, 350 mL, mycin, doripenem, doxycycline, efprozil, enoxacin, 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an ertapenem, erythromycin, ethambutol, flucloxacillin, fosfo aspect, a container can hold from about 25 mL to about 1000 mycin, furazolidone, gatifloxacin, geldanamycin, gentami mL. cin, grepafloxacin, herbimycin, imipenem, isoniazid, In an aspect, a container can hold or accommodate about 10 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 kanamycin, levofloxacin, lincomycin, lineZolid, lomefloxa g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500 g, or 1000 cin, meropenem, meticillin, metronidazole, mezlocillin, g of a compounded composition. In an aspect, a container minocycline, mitomycin, moxifloxacin, mupirocin, nafcil can hold or accommodate about 15 g of a compounded lin, neomycin, netilmicin, nitrofurantoin, norfloxacin, composition. In an aspect, a container can hold or accom 15 ofloxacin, oxacillin, oxytetracycline, paromomycin, penicil modate about 180 g of a compounded composition. In an lin G, penicillin V, piperacillin, pivmecillinam, platensimy aspect, a container can hold or accommodate about 450 g of cin, polymyxin B, prontosil, pvampicillin, pyrazinamide, a compounded composition. In an aspect, a container can quinupristin?dalfopristin, rifampicin, rifampin, roXithromy hold or accommodate about 500 g of a compounded com cin, sparfloxacin, spectinomycin, spiramycin, Sulbactam, position. Sulfacetamide, Sulfamethizole, Sulfamethoxazole, Sulfanil In an aspect, the compounded composition can be a dry imide, Sulfisoxazole, Sulphonamides, Sultamicillin, tellithro powder formulation. mycin, tetracycline, thiamphenicol, ticarcillin, tobramycin, In an aspect, the anti-bacterial agent can be a dry powder. trimethoprim, trimethoprim-Sulfamethoxazole, trolean In an aspect, the anti-bacterial agent can be an ointment. The domycin, trovafloxacin, or a combination thereof. anti-bacterial agent can be pure or Substantially pure. The 25 In an aspect, the anti-bacterial agent of the contained anti-bacterial agent can be obtained from a bulk source. In compounded composition can comprise mupirocin. In an an aspect, the anti-fungal agent can be a dry powder. In an aspect, the anti-bacterial agent of the contained compounded aspect, the anti-fungal agent can be an ointment. The anti composition can comprise azithromycin. fungal agent can be pure or Substantially pure. The anti In an aspect, the anti-fungal agent of the contained fungal agent can be obtained from a bulk source. 30 compounded composition can comprise abafungin, albacon In an aspect, the excipient base powder can comprise LoxasperseTM excipient base powder. In an aspect, the azole, amorolfin, amphotericinb, anidulafungin, bifonazole, excipient base powder can comprise Loxasperse M excipient butenafine, butoconazole, candicidin, caspofungin, base powder and XyliFosTM excipient base powder. In an ciclopiroX, clotrimazole, econazole, fenticonazole, filipin, aspect, an excipient base powder can be obtained from a 35 fluconazole, flucytosine, griseofulvin, haloprogin, hamycin, bulk source. isavuconazole, isoconazole, itraconazole, ketoconazole, In an aspect, the anti-bacterial agent can comprise from micafungin, miconazole, naftifine, natamycin, nystatin, about 10% to about 40% w/w of the contained compounded omoconazole, oxiconazole, polygodial, posaconazole, ravu composition. In an aspect, the anti-bacterial agent can com conazole, rimocidin, Sertaconazole, Sulconazole, terbinafine, prise from about 15% to about 35% w/w of the contained 40 terconazole, tioconazole, tolnaftate, undecylenic acid, Vori compounded composition. In an aspect, the anti-bacterial conazole, or a combination thereof. agent can comprise from about 20% to about 30% w/w of In an aspect, the anti-fungal agent of the contained the contained compounded composition. In an aspect, the compounded composition can comprise itraconazole. In an anti-bacterial agent can comprise about 25% w/w of the aspect, the anti-fungal agent of the contained compounded contained compounded composition. 45 composition can comprise fluconazole. In an aspect, the In an aspect, the anti-fungal agent can comprise from anti-fungal agent of the contained compounded composition about 10% to about 40% w/w of the contained compounded can comprise nyStatin. composition. In an aspect, the anti-fungal agent can com In an aspect, the contained compounded composition can prise from about 15% to about 35% w/w of the contained comprise mupirocin and itraconazole. In an aspect, the compounded composition. In an aspect, the anti-fungal 50 contained compounded composition can comprise azithro agent can comprise from about 20% to about 30% w/w of mycin and fluconazole. In an aspect, the contained com the contained compounded composition. In an aspect, the pounded composition can comprise mupirocin and nystatin. anti-fungal agent can comprise about 25% w/w of the In an aspect, the contained compounded composition can contained compounded composition. comprise one or more additional anti-infective agents. In an In an aspect, the ratio of the anti-bacterial agent to the 55 aspect, the additional anti-infective agent can be a dry anti-fungal agent in the contained compounded composition powder. In an aspect, the additional anti-infective agent can can be from about 1:4 to about 4:1. In an aspect, the ratio of be an ointment. The additional anti-infective agent can be the anti-bacterial agent to the anti-fungal agent can be about pure or substantially pure. The additional anti-infective 1:1. In an aspect, the ratio of the anti-bacterial agent to the agent can be obtained from a bulk source. In an aspect, the anti-fungal agent can be about 1.25:1. See, e.g., Table 1. 60 additional anti-infective agent can be an anti-bacterial agent. In an aspect, the anti-bacterial agent of the contained Anti-bacterial agents are known to the art and discussed compounded composition can comprise afenide, amikacin, Supra. In an aspect, the additional anti-infective agent can be amoxicillin, amplicillin, arsphenamine, azithromycin, azlo an anti-fungal agent. Anti-fungal agents are known to the art cillin, aztreonam, bacampicillin, bacitracin, carbacephem and discussed Supra. (loracarbef), carbenicillin, cefaclor, cefadroxil, cefalotin, 65 In an aspect, a contained compounded composition can cefamandole, cefazolin, cefdinir, cefditoren, cefepime, comprise one or more excipients or additives. In an aspect, cefixime, cefoperaZone, cefotaxime, cefoxitin, cefpodox excipients or additives include, but are not limited to, the US 9,707,229 B2 45 46 following: solvents, Surfactants, humectants, preservatives, composition. In an aspect, the mupirocin can comprise about flavorings, stabilizers (including antioxidants), binders, and 25% w/w of the contained compounded composition. colorants. In an aspect, the itraconazole can comprise from about In an aspect, a disclosed container can comprise one or 10% to about 40% w/w of the contained compounded more capsules, each encapsulating a disclosed compounded 5 composition. In an aspect, the itraconazole can comprise composition. from about 15% to about 35% w/w of the contained com Disclosed herein is a container comprising one or more pounded composition. In an aspect, the itraconazole can capsules, each capsule comprising a compounded composi comprise from about 20% to about 30% w/w of the con tion, wherein the compounded composition can comprise an tained compounded composition. In an aspect, the itracon 10 azole can comprise about 25% w/w of the contained com anti-bacterial agent, an anti-fungal agent, and an excipient pounded composition. base powder comprising a blend of micronized Xylitol and In an aspect, the ratio of the mupirocin to the itraconazole poloxamers. in the contained compounded composition can be from a. Containers Comprising a Compounded Composition about 1:4 to about 4:1. In an aspect, the ratio of the Comprising Mupirocin and/or Itraconazole 15 mupirocin to the itraconazole can be about 1:1. See, e.g., Disclosed herein is a container comprising a compounded Table 2. composition, wherein the compounded composition can In an aspect, a contained compounded composition com comprise mupirocin, itraconazole, and an excipient base prising mupirocin and itraconazole can comprise one or powder comprising a blend of micronized Xylitol and poloX more additional anti-infective agents. In an aspect, the aS. 2O additional anti-infective agent can be a dry powder. In an In an aspect, the container can be a glass container and can aspect, the additional anti-infective agent can be an oint comprise a stopper or a seal. In an aspect, the container can ment. The additional anti-infective agent can be pure or be a non-glass container and can comprise a stopper or a Substantially pure. The additional anti-infective agent can be seal. The stopper can comprise siliconized or non-sili obtained from a bulk source. In an aspect, the additional conized rubber. The stopper or seal can comprise metal. The 25 anti-infective agent can be an anti-bacterial agent. Anti stopper or seal can comprise a Teflon coating or a Teflon bacterial agents are known to the art and discussed Supra. In treatment. In an aspect, the container can be a disposable an aspect, the additional anti-infective agent can be an packet. The disposable packet can be moisture free. In an anti-fungal agent. Anti-fungal agents are known to the art aspect, the container can be a glass or non-glass vial. and discussed Supra. In an aspect, a container can hold or accommodate about 30 In an aspect, a contained compounded composition can 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 comprise one or more excipients or additives. In an aspect, mL, 150 mL, 175 mL, 200 mL. 250 mL, 300 mL, 350 mL, excipients or additives include, but are not limited to, the 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an following: solvents, Surfactants, humectants, preservatives, aspect, a container can hold from about 25 mL to about 1000 flavorings, stabilizers (including antioxidants), binders, and mL. 35 colorants. In an aspect, a container can hold or accommodate about In an aspect, a disclosed compounded composition com 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 prising mupirocin and itraconazole can be encapsulated in g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500 g, or 1000 one or more capsules. g of a compounded composition comprising mupirocin and Disclosed herein is a container comprising a compounded itraconazole. In an aspect, a container can hold or accom- 40 composition, wherein the compounded composition can modate about 15 g of a compounded composition. In an comprise an anti-bacterial agent, itraconazole, and an excipi aspect, a container can hold or accommodate about 180g of ent base powder comprising a blend of micronized Xylitol a compounded composition. In an aspect, a container can and poloxamers. Disclosed herein is a container comprising hold or accommodate about 450 g of a compounded com a compounded composition, wherein the compounded com position. In an aspect, a container can hold or accommodate 45 position can comprise mupirocin, an anti-fungal agent, and about 500 g of a compounded composition. an excipient base powder comprising a blend of micronized In an aspect, the compounded composition can be a dry Xylitol and poloxamers. Disclosed herein is a container powder formulation. comprising a compounded composition, wherein the com In an aspect, the mupirocin can be a dry powder. In an pounded composition can comprise mupirocin, itraconazole, aspect, the mupirocin can be an ointment. The mupirocin can 50 an excipient base powder comprising a blend of micronized be pure or substantially pure. The mupirocin can be obtained Xylitol and poloxamers, and at least one additional anti from a bulk source. In an aspect, the itraconazole can be a infective agent. Disclosed herein is a container comprising dry powder. In an aspect, the itraconazole can be an oint one or more capsules, each capsule comprising a com ment. The itraconazole can be pure or Substantially pure. pounded composition, wherein the compounded composi The itraconazole can be obtained from a bulk source. 55 tion can comprise mupirocin, itraconazole, and an excipient In an aspect, the excipient base powder can comprise base powder comprising a blend of micronized Xylitol and LoxasperseTM excipient base powder. In an aspect, the poloxamers. excipient base powder can comprise Loxasperse M excipient b. Containers Comprising a Compounded Composition base powder and XyliFosTM excipient base powder. In an Comprising Azithromycin and/or Fluconazole aspect, an excipient base powder can be obtained from a 60 Disclosed herein is a container comprising a compounded bulk source. composition, wherein the compounded composition can In an aspect, the mupirocin can comprise from about 10% comprise azithromycin, fluconazole, and an excipient base to about 40% w/w of the contained compounded composi powder comprising a blend of micronized Xylitol and poloX tion. In an aspect, the mupirocin can comprise from about aS. 15% to about 35% w/w of the contained compounded 65 In an aspect, the container can be a glass container and can composition. In an aspect, the mupirocin can comprise from comprise a stopper or a seal. In an aspect, the container can about 20% to about 30% w/w of the contained compounded be a non-glass container and can comprise a stopper or a US 9,707,229 B2 47 48 seal. The stopper can comprise siliconized or non-sili Substantially pure. The additional anti-infective agent can be conized rubber. The stopper or seal can comprise metal. The obtained from a bulk source. In an aspect, the additional stopper or seal can comprise a Teflon coating or a Teflon anti-infective agent can be an anti-bacterial agent. Anti treatment. In an aspect, the container can be a disposable bacterial agents are known to the art and discussed Supra. In packet. The disposable packet can be moisture free. In an 5 an aspect, the additional anti-infective agent can be an aspect, the container can be a glass or non-glass vial. anti-fungal agent. Anti-fungal agents are known to the art In an aspect, a container can hold or accommodate about and discussed Supra. 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 In an aspect, a contained compounded composition can mL, 150 mL, 175 mL, 200 mL, 250 mL, 300 mL, 350 mL, comprise one or more excipients or additives. In an aspect, 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an 10 aspect, a container can hold from about 25 mL to about 1000 excipients or additives include, but are not limited to, the mL. following: solvents, Surfactants, humectants, preservatives, In an aspect, a container can hold or accommodate about flavorings, stabilizers (including antioxidants), binders, and 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 colorants. g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500 g, or 1000 15 In an aspect, a contained compounded composition com g of a compounded composition. In an aspect, a container prising azithromycin and fluconazole can be encapsulated in can hold or accommodate about 15 g of a compounded one or more capsules. composition. In an aspect, a container can hold or accom Disclosed herein is a container comprising a compounded modate about 180 g of a compounded composition. In an composition, wherein the compounded composition can aspect, a container can hold or accommodate about 450 g of comprise an anti-bacterial agent, fluconazole, and an excipi a compounded composition. ent base powder comprising a blend of micronized Xylitol In an aspect, the contained compounded composition can and poloxamers. be a dry powder formulation. In an aspect, the azithromycin Disclosed herein is a container comprising a compounded can be a dry powder. In an aspect, the azithromycin can be composition, wherein the compounded composition can an ointment. The azithromycin can be pure or Substantially 25 comprise azithromycin, an anti-fungal agent, and an excipi pure. The azithromycin can be obtained from a bulk source. ent base powder comprising a blend of micronized Xylitol In an aspect, the fluconazole can be a dry powder. In an and poloxamers. aspect, the fluconazole can be an ointment. The fluconazole Disclosed herein is a container comprising a compounded can be pure or substantially pure. The fluconazole can be composition, wherein the compounded composition can obtained from a bulk source. 30 comprise azithromycin, fluconazole, an excipient base pow In an aspect, the excipient base powder can comprise der comprising a blend of micronized Xylitol and poloxam LoxasperseTM excipient base powder. In an aspect, the ers, and at least one additional anti-infective agent. Dis excipient base powder can comprise Loxasperse M excipient closed herein is a container comprising one or more base powder and XyliFosTM excipient base powder. In an capsules, each capsule comprising a compounded composi aspect, an excipient base powder can be obtained from a 35 tion, wherein the compounded composition can comprise bulk source. azithromycin, fluconazole, and an excipient base powder In an aspect, the azithromycin can comprise from about comprising a blend of micronized Xylitol and poloxamers. 10% to about 60% w/w of the compounded composition. In c. Containers Comprising a Compounded Composition an aspect, the azithromycin can comprise from about 20% to Comprising Mupirocin and/or Nystatin about 50% w/w of the compounded composition. In an 40 Disclosed herein is a container comprising a compounded aspect, the azithromycin can comprise from about 30% to composition, wherein the compounded composition can about 40% w/w of the compounded composition. In an comprise mupirocin, nystatin, and an excipient base powder aspect, the azithromycin can comprise about 25% w/w of the comprising a blend of micronized Xylitol and poloxamers. compounded composition. In an aspect, the azithromycin In an aspect, the container can be a glass container and can can comprise about 50% w/w of the compounded compo 45 comprise a stopper or a seal. In an aspect, the container can sition. be a non-glass container and can comprise a stopper or a In an aspect, the fluconazole can comprise from about seal. The stopper can comprise siliconized or non-sili 10% to about 60% w/w of the compounded composition. In conized rubber. The stopper or seal can comprise metal. The an aspect, the fluconazole can comprise from about 20% to stopper or seal can comprise a Teflon coating or a Teflon about 50% w/w of the compounded composition. In an 50 treatment. In an aspect, the container can be a disposable aspect, the fluconazole can comprise from about 30% to packet. The disposable packet can be moisture free. In an about 40% w/w of the compounded composition. In an aspect, the container can be a glass or non-glass vial. aspect, the fluconazole can comprise about 25% w/w of the In an aspect, a container can hold or accommodate about compounded composition. In an aspect, the fluconazole can 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 comprise about 50% w/w of the compounded composition. 55 mL, 150 mL, 175 mL, 200 mL, 250 mL, 300 mL, 350 mL, In an aspect, the ratio of the azithromycin to the flucon 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an azole in the contained compounded composition can be from aspect, a container can hold from about 25 mL to about 1000 about 1:4 to about 4:1. In an aspect, the ratio of the mL. azithromycin to the fluconazole can be about 1:1. In an In an aspect, a container can hold or accommodate about aspect, the ratio of the azithromycin to the fluconazole can 60 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 be about 1.25:1. See, e.g., Table 3. g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500g, or 1000 In an aspect, a contained compounded composition com g of a compounded composition. In an aspect, a container prising azithromycin and fluconazole can comprise one or can hold or accommodate about 15 g of a compounded more additional anti-infective agents. In an aspect, the composition. In an aspect, a container can hold or accom additional anti-infective agent can be a dry powder. In an 65 modate about 180 g of a compounded composition. In an aspect, the additional anti-infective agent can be an oint aspect, a container can hold or accommodate about 450 g of ment. The additional anti-infective agent can be pure or a compounded composition. US 9,707,229 B2 49 50 In an aspect, the contained compounded composition can an excipient base powder comprising a blend of micronized be a dry powder formulation. Xylitol and poloxamers. Disclosed herein is a container In an aspect, the mupirocin can be a dry powder. In an comprising a compounded composition, wherein the com aspect, the mupirocin can be an ointment. In an aspect, the pounded composition can comprise mupirocin, nystatin, an mupirocin can be a 2% ointment. The mupirocin can be pure excipient base powder comprising a blend of micronized or substantially pure. The mupirocin can be obtained from a Xylitol and poloxamers, and at least one additional anti bulk source. In an aspect, the nyStatin can be a dry powder. infective agent. Disclosed herein is a container comprising In an aspect, the nystatin can be an ointment. The nyStatin one or more capsules, each capsule comprising a com can be pure or Substantially pure. The nystatin can be pounded composition, wherein the compounded composi obtained from a bulk source. 10 tion can comprise mupirocin, nystatin, and an excipient base In an aspect, the excipient base powder can comprise powder comprising a blend of micronized Xylitol and poloX LoxasperseTM excipient base powder. In an aspect, the aS. excipient base powder can comprise Loxasperse M excipient 1. Containers Comprising an Anti-Bacterial Agent base powder and XyliFosTM excipient base powder. In an Disclosed herein is a container comprising an anti-bacte aspect, an excipient base powder can be obtained from a 15 rial agent. bulk source. In an aspect, the contained anti-bacterial agent can be In an aspect, the mupirocin can comprise from about 10% encapsulated in one or more capsules. to about 40% w/w of the contained compounded composi In an aspect, the container can be a glass container and can tion. In an aspect, the mupirocin can comprise from about comprise a stopper or a seal. In an aspect, the container can 15% to about 35% w/w of the contained compounded be a non-glass container and can comprise a stopper or a composition. In an aspect, the mupirocin can comprise from seal. The stopper can comprise siliconized or non-sili about 20% to about 30% w/w of the contained compounded conized rubber. The stopper or seal can comprise metal. The composition. In an aspect, the mupirocin can comprise about stopper or seal can comprise a Teflon coating or a Teflon 25% w/w of the contained compounded composition. treatment. In an aspect, the container can be a disposable In an aspect, the nystatin can comprise from about 10% to 25 packet. The disposable packet can be moisture free. In an about 40% w/w of the contained compounded composition. aspect, the container can be a glass or non-glass vial. In an aspect, the nyStatin can comprise from about 15% to In an aspect, a container can hold or accommodate about about 35% w/w of the contained compounded composition. 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 In an aspect, the nyStatin can comprise from about 20% to mL, 150 mL, 175 mL, 200 mL, 250 mL, 300 mL, 350 mL, about 30% w/w of the contained compounded composition. 30 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an In an aspect, the nystatin can comprise about 25% w/w of the aspect, a container can hold from about 25 mL to about 1000 contained compounded composition. mL. In an aspect, the ratio of the mupirocin to the nystatin in In an aspect, a container can hold or accommodate about the contained compounded composition can be from about 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 1:4 to about 4:1. In an aspect, the ratio of the mupirocin to 35 g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500g, or 1000 the nyStatin can be about 1:1. In an aspect, the ratio of the g of an anti-bacterial agent. In an aspect, a container can mupirocin to the nystatin can be about 1.25:1. See, e.g., hold or accommodate about 15 g of an anti-bacterial agent. Table 3. In an aspect, a container can hold or accommodate about 180 In an aspect, a contained compounded composition com g of an anti-bacterial agent. In an aspect, a container can prising azithromycin and fluconazole can comprise one or 40 hold or accommodate about 450 g of an anti-bacterial agent. more additional anti-infective agents. In an aspect, the In an aspect, a container can hold or accommodate about 500 additional anti-infective agent can be a dry powder. In an g of an anti-bacterial agent. aspect, the additional anti-infective agent can be an oint In an aspect, the anti-bacterial agent can be a dry powder. ment. The additional anti-infective agent can be pure or In an aspect, the anti-bacterial agent can be an ointment. The Substantially pure. The additional anti-infective agent can be 45 anti-bacterial agent can be pure or Substantially pure. The obtained from a bulk source. In an aspect, the additional anti-bacterial agent can be obtained from a bulk source. anti-infective agent can be an anti-bacterial agent. Anti In an aspect, the disclosed container can comprise an bacterial agents are known to the art and discussed Supra. In excipient base powder comprising a blend of micronized an aspect, the additional anti-infective agent can be an Xylitol and poloxamers. In an aspect, the excipient base anti-fungal agent. Anti-fungal agents are known to the art 50 powder can comprise LoxasperseTM excipient base powder. and discussed Supra. The excipient base powder can comprise LoxasperseTM In an aspect, a contained compounded composition can excipient base powder and XyliFosTM excipient base pow comprise one or more excipients or additives. In an aspect, der. In an aspect, an excipient base powder can be obtained excipients or additives include, but are not limited to, the from a bulk source. following: solvents, Surfactants, humectants, preservatives, 55 In an aspect, the contained anti-bacterial agent can com flavorings, stabilizers (including antioxidants), binders, and prise afenide, amikacin, amoxicillin, amplicillin, arsphe colorants. namine, azithromycin, azlocillin, aztreonam, bacampicillin, In an aspect, a contained compounded composition com bacitracin, carbacephem (loracarbef), carbenicillin, cefaclor, prising mupirocin and nystatin can be encapsulated in one or cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi more capsules. 60 toren, cefepime, cefixime, cefoperaZone, cefotaxime, Disclosed herein is a container comprising a compounded cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, composition, wherein the compounded composition can ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha comprise an anti-bacterial agent, nystatin, and an excipient lexin, chloramphenicol, chlorhexidine, ciprofloxacin, base powder comprising a blend of micronized Xylitol and clarithromycin, clavulanic acid, clindamycin, cloxacillin, poloxamers. Disclosed herein is a container comprising a 65 colimycin, colistimethate teicoplanin, colistin, demeclocy compounded composition, wherein the compounded com cline, dicloxacillin, dirithromycin, doripenem, doxycycline, position can comprise mupirocin, an anti-fungal agent, and efprozil, enoxacin, ertapenem, erythromycin, ethambutol, US 9,707,229 B2 51 52 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, excipient base powder and XyliFosTM excipient base pow geldanamycin, gentamicin, grepafloxacin, herbimycin, imi der. In an aspect, an excipient base powder can be obtained penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin from a bulk source. eZolid, lomefloxacin, meropenem, meticillin, metronidazole, In an aspect, the contained anti-fungal agent can comprise meZlocillin, minocycline, mitomycin, moxifloxacin, mupi abafungin, albaconazole, amorolfin, amphotericin b, anidu rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor lafungin, bifonazole, butenafine, butoconazole, candicidin, floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy caspofungin, ciclopiroX, clotrimazole, econazole, fenticon cin, penicillin G, penicillin V, piperacillin, pivmecillinam, azole, filipin, fluconazole, flucytosine, griseofulvin, halo platensimycin, polymyxin B, prontosil, pvampicillin, progin, hamycin, isavuconazole, isoconazole, itraconazole, pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam 10 ketoconazole, micafungin, miconazole, naftifine, natamycin, pin, roXithromycin, sparfloxacin, spectinomycin, spiramy nystatin, omoconazole, oxiconazole, polygodial, posacon cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, terbinafine, terconazole, tioconazole, tolnaftate, undecylenic Sultamicillin, tellithromycin, tetracycline, thiamphenicol, acid, Voriconazole, or a combination thereof. ticarcillin, tobramycin, trimethoprim, trimethoprim-sul 15 In an aspect, the contained anti-fungal agent can comprise famethoxazole, troleandomycin, trovafloxacin, or a combi itraconazole. In an aspect, the contained anti-fungal agent nation thereof. can comprise fluconazole. In an aspect, the contained anti In an aspect, the contained anti-bacterial agent can com fungal agent can comprise nystatin. prise mupirocin. In an aspect, the contained anti-bacterial In an aspect, a disclosed container comprising an anti agent can comprise azithromycin. fungal agent can comprise one or more excipients or addi In an aspect, a disclosed container can comprise one or tives. In an aspect, excipients or additives include, but are more excipients or additives. In an aspect, excipients or not limited to, the following: solvents, Surfactants, humec additives include, but are not limited to, the following: tants, preservatives, flavorings, stabilizers (including anti Solvents, Surfactants, humectants, preservatives, flavorings, 25 oxidants), binders, and colorants. stabilizers (including antioxidants), binders, and colorants. In an aspect, an anti-fungal agent can be encapsulated in 2. Containers Comprising an Anti-Fungal Agent one or more capsules. Disclosed herein is a container comprising an anti-fungal B. Kits agent. 1. Kits Comprising a Compounded Composition 30 Disclosed herein is a kit comprising a disclosed com In an aspect, the contained anti-fungal agent can be pounded composition. encapsulated in one or more capsules. Disclosed herein is a kit, comprising: one or more con In an aspect, the container can be a glass container and can tainers, each comprising a compounded composition, comprise a stopper or a seal. In an aspect, the container can wherein the compounded composition can comprise a thera be a non-glass container and can comprise a stopper or a 35 peutically effective amount of an anti-bacterial agent, a seal. The stopper can comprise siliconized or non-sili therapeutically effective amount of an anti-fungal agent, and conized rubber. The stopper or seal can comprise metal. The an amount of an excipient base powder comprising a blend stopper or seal can comprise a Teflon coating or a Teflon of micronized Xylitol and poloxamers. treatment. In an aspect, the container can be a disposable In an aspect, the kit can comprise instructions for using packet. The disposable packet can be moisture free. In an 40 the compounded composition. aspect, the container can be a glass or non-glass vial. In an aspect, the kit can comprise a foot bath. In an aspect, In an aspect, a container can hold or accommodate about a foot bath can comprise a mechanical agitation agent to 5 mL, 10 mL, 15 mL, 25 mL, 50 mL, 75 mL, 100 mL, 125 mechanically agitate the enclosed water, a heating agent to mL, 150 mL, 175 mL, 200 mL, 250 mL, 300 mL, 350 mL, heat the enclosed water, or both. Mechanical agitation agents 400 mL, 450 mL, 500 mL, or 1000 mL of a liquid. In an 45 and/or means to agitate water within a compartment are aspect, a container can hold from about 25 mL to about 1000 known to the art. In an aspect, a mechanical agitation agent mL. can be a motorized agitation agent. In an aspect, an agitation In an aspect, a container can hold or accommodate about agent or an agitator can be coupled to both a motor and the 5 g, 10 g, 15 g, 25 g, 50 g, 75 g, 100 g, 125 g, 150 g, 175 foot bath. Motors and agitators are known to the art. In an g, 200g, 250 g., 300 g, 350 g, 400 g, 450 g, 500 g, or 1000 50 aspect, mechanical agitation can serve to distribute the g of an anti-fungal agent. In an aspect, a container can hold compounded composition throughout the water contained or accommodate about 15 g of an anti-fungal agent. In an within the foot bath. Heating agents and/or means to heat aspect, a container can hold or accommodate about 180g of water in a compartment are known to the art. an anti-fungal agent. In an aspect, a container can hold or In an aspect, the kit can comprise one or more funnels. In accommodate about 450 g of an anti-fungal agent. In an 55 an aspect, the kit can comprise one or more mixing con aspect, a container can hold or accommodate about 500 g of tainers. In an aspect, the kit can comprise one or more an anti-fungal agent. Scoops. In an aspect, the anti-fungal agent can be a dry powder. In In an aspect, the kit can comprise a diluent for the an aspect, the anti-fungal agent can be an ointment. In an compounded composition. In an aspect, the diluent can aspect, the anti-fungal agent can be obtained from a bulk 60 comprise sodium hypochlorite. In an aspect, the diluent can Source. The anti-fungal agent can be pure or Substantially comprise Dakin's solution. pure. In an aspect, the excipient base powder can comprise In an aspect, the disclosed container can comprise an LoxasperseTM excipient base powder. In an aspect, the excipient base powder comprising a blend of micronized excipient base powder can comprise Loxasperse M excipient Xylitol and poloxamers. In an aspect, the excipient base 65 base powder and XyliFosTM excipient base powder. In an powder can comprise LoxasperseTM excipient base powder. aspect, an excipient base powder can be obtained from a The excipient base powder can comprise LoxasperseTM bulk source. US 9,707,229 B2 53 54 In an aspect, the anti-bacterial agent can be a dry powder. caspofungin, ciclopiroX, clotrimazole, econazole, fenticon In an aspect, the anti-bacterial agent can be an ointment. The azole, filipin, fluconazole, flucytosine, griseofulvin, halo anti-bacterial agent can be pure or Substantially pure. The progin, hamycin, isavuconazole, isoconazole, itraconazole, anti-bacterial agent can be obtained from a bulk source. In ketoconazole, micafungin, miconazole, naftifine, natamycin, an aspect, the anti-fungal agent can be a dry powder. In an 5 nystatin, omoconazole, oxiconazole, polygodial, posacon aspect, the anti-fungal agent can be an ointment. The anti azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, fungal agent can be pure or Substantially pure. The anti terbinafine, terconazole, tioconazole, tolnaftate, undecylenic fungal agent can be obtained from a bulk source. acid, Voriconazole, or a combination thereof. In an aspect, the anti-bacterial agent can comprise from In an aspect of a disclosed kit, the compounded compo about 10% to about 40% w/w of the compounded compo 10 sition can comprise itraconazole. In an aspect of a disclosed sition. In an aspect, the anti-bacterial agent can comprise kit, the compounded composition can comprise fluconazole. from about 15% to about 35% w/w of the compounded In an aspect of a disclosed kit, the compounded composition composition. In an aspect, the anti-bacterial agent can com can comprise nyStatin. prise from about 20% to about 30% w/w of the compounded In an aspect of a disclosed kit, the compounded compo composition. In an aspect, the anti-bacterial agent can com 15 sition can comprise mupirocin and itraconazole. In an aspect prise about 25% w/w of the compounded composition. of a disclosed kit, the compounded composition can com In an aspect, the anti-fungal agent can comprise from prise azithromycin and fluconazole. In an aspect of a dis about 10% to about 40% w/w of the compounded compo closed kit, the compounded composition can comprise sition. In an aspect, the anti-fungal agent can comprise from mupirocin and nystatin. about 15% to about 35% w/w of the compounded compo In an aspect, a disclosed kit can comprise one or one or sition. In an aspect, the anti-fungal agent can comprise from more containers of one or more additional anti-infective about 20% to about 30% w/w of the compounded compo agents. In an aspect of a disclosed kit, a compounded sition. In an aspect, the anti-fungal agent can comprise about composition can comprise one or more additional anti 25% w/w of the compounded composition. infective agents. In an aspect, the additional anti-infective In an aspect, the ratio of the anti-bacterial agent to the 25 agent can be a dry powder. In an aspect, the additional anti-fungal agent in the compounded composition can be anti-infective agent can be an ointment. The additional from about 1:4 to about 4:1. In an aspect, the ratio of the anti-infective agent can be pure or Substantially pure. The anti-bacterial agent to the anti-fungal agent can be about 1:1. additional anti-infective agent can be obtained from a bulk In an aspect, the ratio of the anti-bacterial agent to the Source. In an aspect, the additional anti-infective agent can anti-fungal agent can be about 1:1.25. See, e.g., Table 1. 30 be an anti-bacterial agent. Anti-bacterial agents are known to In an aspect, the anti-bacterial agent can comprise the art and discussed Supra. In an aspect, the additional afenide, amikacin, amoxicillin, ampicillin, arsphenamine, anti-infective agent can be an anti-fungal agent. Anti-fungal azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra agents are known to the art and discussed Supra. cin, carbacephem (loracarbef), carbenicillin, cefaclor, In an aspect, a disclosed kit can comprise a plurality of cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi 35 containers, each comprising a compounded composition toren, cefepime, cefixime, cefoperaZone, cefotaxime, comprising an anti-bacterial agent and an anti-fungal agent. cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, In an aspect, a plurality can comprise about 30 containers, or ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha about 60 containers, or about 90 containers, or more con lexin, chloramphenicol, chlorhexidine, ciprofloxacin, tainers. In an aspect, a plurality can comprise 120 containers clarithromycin, clavulanic acid, clindamycin, cloxacillin, 40 or more of the compounded composition. In an aspect, the colimycin, colistimethate teicoplanin, colistin, demeclocy kit can comprise an amount that the skilled person considers cline, dicloxacillin, dirithromycin, doripenem, doxycycline, a monthly supply of the compounded composition. efprozil, enoxacin, ertapenem, erythromycin, ethambutol, Disclosed herein is a kit, comprising: one or more con flucloxacillin, fosfomycin, furazolidone, gatifloxacin, tainers, each comprising a compounded composition, geldanamycin, gentamicin, grepafloxacin, herbimycin, imi 45 wherein the compounded composition can comprise a thera penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin peutically effective amount of an anti-bacterial agent, a eZolid, lomefloxacin, meropenem, meticillin, metronidazole, therapeutically effective amount of an anti-fungal agent, and meZlocillin, minocycline, mitomycin, moxifloxacin, mupi an excipient base powder comprising a blend of micronized rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor Xylitol and poloxamers, and instructions for using the com floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy 50 pounded composition. cin, penicillin G, penicillin V, piperacillin, pivmecillinam, In an aspect, the anti-bacterial agent can comprise mupi platensimycin, polymyxin B, prontosil, pvampicillin, rocin. In an aspect, the anti-fungal agent can comprise pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam itraconazole. In an aspect of a disclosed kit, the compounded pin, roXithromycin, sparfloxacin, spectinomycin, spiramy composition can comprise mupirocin and itraconazole. In an cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox 55 aspect, the anti-bacterial agent can comprise azithromycin. azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, In an aspect, the anti-fungal agent can comprise fluconazole. Sultamicillin, tellithromycin, tetracycline, thiamphenicol, In an aspect of a disclosed kit, the compounded composition ticarcillin, tobramycin, trimethoprim, trimethoprim-sul can comprise azithromycin and fluconazole. In an aspect, the famethoxazole, troleandomycin, trovafloxacin, or a combi anti-bacterial agent can comprise mupirocin. In an aspect, nation thereof. 60 the anti-fungal agent can comprise nystatin. In an aspect of In an aspect of a disclosed kit, the compounded compo a disclosed kit, the compounded composition can comprise sition can comprise mupirocin. mupirocin and nystatin. In an aspect of a disclosed kit, the compounded compo Disclosed herein is a kit, comprising: one or more con sition can comprise azithromycin. tainers, each comprising a compounded composition, In an aspect, the anti-fungal agent can comprise aba 65 wherein the compounded composition can comprise a thera fungin, albaconazole, amorolfin, amphotericin b, anidula peutically effective amount of an anti-bacterial agent, a fungin, bifonazole, butenafine, butoconazole, candicidin, therapeutically effective amount of an anti-fungal agent, and US 9,707,229 B2 55 56 an excipient base powder comprising a blend of micronized powder comprising a blend of micronized Xylitol and poloX Xylitol and poloxamers, a foot bath, and instructions for amers, a foot bath, and instructions for using the com using the compounded composition. pounded composition. In an aspect, the one or more con In an aspect, the anti-bacterial agent can comprise mupi tainers, each comprising a compounded composition rocin. In an aspect, the anti-fungal agent can comprise comprising azithromycin and fluconazole, can comprise itraconazole. In an aspect of a disclosed kit, the compounded about 30 containers, or about 60 containers, or about 90 composition can comprise mupirocin and itraconazole. In an containers, or more containers. In an aspect, a disclosed kit aspect, the anti-bacterial agent can comprise azithromycin. can comprise 120 containers or more of the compounded In an aspect, the anti-fungal agent can comprise fluconazole. composition comprising azithromycin and fluconazole. In an In an aspect of a disclosed kit, the compounded composition 10 aspect, the kit can comprise an amount that the skilled can comprise azithromycin and fluconazole. In an aspect, the person considers a monthly Supply of the compounded anti-bacterial agent can comprise mupirocin. In an aspect, composition comprising azithromycin and fluconazole. the anti-fungal agent can comprise nystatin. In an aspect of c. Compounded Composition Comprising Mupirocin and/ a disclosed kit, the compounded composition can comprise or Nystatin mupirocin and nystatin. 15 Disclosed herein is a kit, comprising: one or more con a. Compounded Composition Comprising Mupirocin and/ tainers, each comprising a compounded composition, or Itraconazole wherein the compounded composition can comprise a thera Disclosed herein is a kit, comprising: one or more con peutically effective amount of mupirocin, a therapeutically tainers, each comprising a compounded composition, effective amount of nyStatin, and an excipient base powder wherein the compounded composition can comprise a thera comprising a blend of micronized Xylitol and poloxamers. peutically effective amount of mupirocin, a therapeutically Disclosed herein is a kit, comprising: one or more contain effective amount of itraconazole, and an excipient base ers, each comprising a compounded composition, wherein powder comprising a blend of micronized Xylitol and poloX the compounded composition can comprise a therapeutically amers. Disclosed herein is a kit, comprising: one or more effective amount of mupirocin, a therapeutically effective containers, each comprising a compounded composition, 25 amount of nystatin, and an excipient base powder compris wherein the compounded composition can comprise a thera ing a blend of micronized Xylitol and poloxamers, and peutically effective amount of mupirocin, a therapeutically instructions for using the compounded composition. Dis effective amount of itraconazole, and an excipient base closed herein is a kit, comprising: one or more containers, powder comprising a blend of micronized Xylitol and poloX each comprising a compounded composition, wherein the amers, and instructions for using the compounded compo 30 compounded composition can comprise a therapeutically sition. Disclosed herein is a kit, comprising: one or more effective amount of mupirocin, a therapeutically effective containers, each comprising a compounded composition, amount of nystatin, and an excipient base powder compris wherein the compounded composition can comprise a thera ing a blend of micronized Xylitol and poloxamers, a foot peutically effective amount of mupirocin, a therapeutically bath, and instructions for using the compounded composi effective amount of itraconazole, and an excipient base 35 tion. In an aspect, the one or more containers, each com powder comprising a blend of micronized Xylitol and poloX prising a compounded composition comprising mupirocin amers, a foot bath, and instructions for using the com and nystatin, can comprise about 30 containers, or about 60 pounded composition. In an aspect, a disclosed kit can containers, or about 90 containers, or more containers. In an comprise a plurality of containers, each comprising a com aspect, a disclosed kit can comprise 120 containers or more pounded composition comprising mupirocin and itracon 40 of the compounded composition comprising mupirocin and azole. In an aspect, a plurality can comprise about 30 nystatin. In an aspect, the kit can comprise an amount that containers, or about 60 containers, or about 90 containers, or the skilled person considers a monthly Supply of the com more containers. In an aspect, a plurality can comprise 120 pounded composition comprising mupirocin and nystatin. containers or more of the compounded composition com 1. Kits Comprising an Anti-Bacterial Agent and an Anti prising mupirocin and itraconazole. In an aspect, the kit can 45 Fungal Agent comprise an amount that the skilled person considers a Disclosed herein is a kit comprising an anti-bacterial monthly supply of the compounded composition. agent and an anti-fungal agent. b. Compounded Composition Comprising Azithromycin Disclosed herein is a kit, comprising: one or more con and/or Fluconazole tainers comprising a therapeutically effective amount of an Disclosed herein is a kit, comprising: one or more con 50 anti-bacterial agent and one or more containers comprising tainers, each comprising a compounded composition, a therapeutically effective amount of an anti-fungal agent. wherein the compounded composition can comprise a thera In an aspect, the kit can comprise instructions for using peutically effective amount of azithromycin, a therapeuti the anti-bacterial agent and the anti-fungal agent. cally effective amount of fluconazole, and an excipient base In an aspect, the kit can comprise a foot bath. In an aspect, powder comprising a blend of micronized Xylitol and poloX 55 a foot bath can comprise a mechanical agitation agent to amers. Disclosed herein is a kit, comprising: one or more mechanically agitate the enclosed water, a heating agent to containers, each comprising a compounded composition, heat the enclosed water, or both. Mechanical agitation agents wherein the compounded composition can comprise a thera and/or means to agitate water within a compartment are peutically effective amount of azithromycin, a therapeuti known to the art. In an aspect, a mechanical agitation agent cally effective amount of fluconazole, and an excipient base 60 can be a motorized agitation agent. In an aspect, an agitation powder comprising a blend of micronized Xylitol and poloX agent or an agitator can be coupled to both a motor and the amers, and instructions for using the compounded compo foot bath. Motors and agitators are known to the art. In an sition. Disclosed herein is a kit, comprising: one or more aspect, mechanical agitation can serve to distribute the containers, each comprising a compounded composition, anti-bacterial agent and the anti-fungal agent or both wherein the compounded composition can comprise a thera 65 throughout the water contained within the foot bath. Heating peutically effective amount of azithromycin, a therapeuti agents and/or means to heat water in a compartment are cally effective amount of fluconazole, and an excipient base known to the art. US 9,707,229 B2 57 58 In an aspect, the kit can comprise one or more funnels. In In an aspect of a disclosed kit, the anti-bacterial agent can an aspect, the kit can comprise one or more mixing con comprise mupirocin. In an aspect of a disclosed kit, the tainers. In an aspect, the kit can comprise one or more anti-bacterial agent can comprise azithromycin. Scoops. In an aspect, the anti-fungal agent of a disclosed kit can In an aspect, the kit can comprise a diluent for the comprise abafungin, albaconazole, amorolfin, amphotericin anti-bacterial agent. In an aspect, the kit can comprise a b, anidulafungin, bifonazole, butenafine, butoconazole, can diluent for the anti-fungal agent. In an aspect, the diluent can dicidin, caspofungin, ciclopiroX, clotrimazole, econazole, comprise sodium hypochlorite. In an aspect, the diluent can fenticonazole, filipin, fluconazole, flucytosine, griseofulvin, comprise Dakin's Solution. In an aspect, the diluent for the haloprogin, hamycin, isavuconazole, isoconazole, itracon 10 azole, ketoconazole, micafungin, miconazole, naftifine, anti-bacterial agent is the same as the diluent for the anti natamycin, nystatin, omoconazole, oxiconazole, polygodial, fungal agent. In an aspect, the diluent for the anti-bacterial posaconazole, ravuconazole, rimocidin, Sertaconazole, Sul agent is different than the diluent for the anti-fungal agent. conazole, terbinafine, terconazole, tioconazole, tolnaftate, In an aspect, a disclosed kit can comprise one or more undecylenic acid, Voriconazole, or a combination thereof. containers comprising an excipient base powder comprising 15 In an aspect of a disclosed kit, the anti-fungal agent can a blend of micronized Xylitol and poloxamers. In an aspect, comprise itraconazole. In an aspect of a disclosed kit, the the excipient base powder can comprise LoxasperseTM anti-fungal agent can comprise fluconazole. In an aspect of excipient base powder. In an aspect, the excipient base a disclosed kit, the anti-fungal agent can comprise nystatin. powder can comprise LoxasperseTM excipient base powder In an aspect, a disclosed kit can comprise mupirocin and and XyliFosTM excipient base powder. In an aspect, an itraconazole. In an aspect, a disclosed kit can comprise excipient base powder can be obtained from a bulk source. azithromycin and fluconazole. In an aspect, a disclosed kit In an aspect, the anti-bacterial agent can be a dry powder. can comprise mupirocin and nystatin. In an aspect, the anti-bacterial agent can be an ointment. The In an aspect, a disclosed kit can comprise one or more anti-bacterial agent can be pure or Substantially pure. The containers, each comprising one or more additional anti anti-bacterial agent can be obtained from a bulk source. In 25 infective agents. In an aspect, the additional anti-infective an aspect, the anti-fungal agent can be a dry powder. In an agent can be a dry powder. In an aspect, the additional aspect, the anti-fungal agent can be an ointment. The anti anti-infective agent can be an ointment. The additional fungal agent can be pure or Substantially pure. The an anti-infective agent can be pure or Substantially pure. The anti-fungal agent can be obtained from a bulk source. additional anti-infective agent can be obtained from a bulk In an aspect, the amount of anti-bacterial agent used in a 30 Source. In an aspect, the additional anti-infective agent can disclosed kit compared to the amount of anti-fungal agent be an anti-bacterial agent. Anti-bacterial agents are known to used can be from about 1:4 to about 4:1. In an aspect, the the art and discussed supra. In an aspect, the additional amount of anti-bacterial agent used in a disclosed kit com anti-infective agent can be an anti-fungal agent. Anti-fungal pared to the amount of anti-fungal agent used can be about agents are known to the art and discussed Supra. 1:1. In an aspect, the amount of anti-bacterial agent used in 35 In an aspect, a disclosed kit can comprise a plurality of a disclosed kit compared to the amount of anti-fungal agent containers, each comprising an anti-bacterial agent. In an used can be about 1.25:1. aspect, a plurality can comprise about 30 containers, or In an aspect, the anti-bacterial agent in a disclosed kit can about 60 containers, or about 90 containers, or more con comprise afenide, amikacin, amoxicillin, amplicillin, arsphe tainers. In an aspect, a plurality can comprise 120 containers namine, azithromycin, azlocillin, aztreonam, bacampicillin, 40 or more of the anti-bacterial agent. In an aspect, the kit can bacitracin, carbacephem (loracarbef), carbenicillin, cefaclor, comprise an amount that the skilled person considers a cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi monthly supply of the anti-bacterial agent. toren, cefepime, cefixime, cefoperaZone, cefotaxime, In an aspect, a disclosed kit can comprise a plurality of cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, containers, each comprising an anti-fungal agent. In an ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha 45 aspect, a plurality can comprise about 30 containers, or lexin, chloramphenicol, chlorhexidine, ciprofloxacin, about 60 containers, or about 90 containers, or more con clarithromycin, clavulanic acid, clindamycin, cloxacillin, tainers. In an aspect, a plurality can comprise 120 containers colimycin, colistimethate teicoplanin, colistin, demeclocy or more of the anti-fungal agent. In an aspect, the kit can cline, dicloxacillin, dirithromycin, doripenem, doxycycline, comprise an amount that the skilled person considers a efprozil, enoxacin, ertapenem, erythromycin, ethambutol, 50 monthly supply of the anti-fungal agent. flucloxacillin, fosfomycin, furazolidone, gatifloxacin, Disclosed herein is a kit, comprising: one or more con geldanamycin, gentamicin, grepafloxacin, herbimycin, imi tainers comprising a therapeutically effective amount of an penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin anti-bacterial agent or one or more containers comprising a eZolid, lomefloxacin, meropenem, meticillin, metronidazole, therapeutically effective amount of an anti-fungal agent, a meZlocillin, minocycline, mitomycin, moxifloxacin, mupi 55 foot bath, and instructions for using the anti-bacterial agent rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor and the anti-fungal agent. floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy In an aspect, the anti-bacterial agent can comprise mupi cin, penicillin G, penicillin V, piperacillin, pivmecillinam, rocin. In an aspect, the anti-fungal agent can comprise platensimycin, polymyxin B, prontosil, pvampicillin, itraconazole. In an aspect, a disclosed kit can comprise pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam 60 mupirocin and itraconazole. In an aspect, the anti-bacterial pin, roXithromycin, sparfloxacin, spectinomycin, spiramy agent can comprise azithromycin. In an aspect, the anti cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox fungal agent can comprise fluconazole. In an aspect, a azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, disclosed kit can comprise azithromycin and fluconazole. In Sultamicillin, tellithromycin, tetracycline, thiamphenicol, an aspect, the anti-bacterial agent can comprise mupirocin. ticarcillin, tobramycin, trimethoprim, trimethoprim-sul 65 In an aspect, the anti-fungal agent can comprise nystatin. In famethoxazole, troleandomycin, trovafloxacin, or a combi an aspect, a disclosed kit can comprise mupirocin and nation thereof. nystatin. US 9,707,229 B2 59 60 Disclosed herein is a kit, comprising: one or more con In an aspect, the amount of the mupirocin used in a tainers comprising a therapeutically effective amount of an disclosed kit compared to the amount of the itraconazole anti-bacterial agent or one or more containers comprising a used can be from about 1:4 to about 4:1. In an aspect, the therapeutically effective amount of an anti-fungal agent, a amount of the mupirocin used in a disclosed kit compared to foot bath, and instructions for using the anti-bacterial agent 5 the amount of the itraconazole used can be about 1:1. In an and the anti-fungal agent. aspect, the amount of the mupirocin used in a disclosed kit In an aspect, the anti-bacterial agent can comprise mupi compared to the amount of the itraconazole used can be rocin. In an aspect, the anti-fungal agent can comprise about 1.25:1. itraconazole. In an aspect, a disclosed kit can comprise In an aspect, a disclosed kit can comprise one or more mupirocin and itraconazole. In an aspect, the anti-bacterial 10 containers comprising one or more additional anti-infective agent can comprise azithromycin. In an aspect, the anti agents. In an aspect, the additional anti-infective agent can fungal agent can comprise fluconazole. In an aspect, a be a dry powder. In an aspect, the additional anti-infective disclosed kit can comprise azithromycin and fluconazole. In agent can be an ointment. The additional anti-infective agent an aspect, the anti-bacterial agent can comprise mupirocin. can be pure or Substantially pure. The additional anti In an aspect, the anti-fungal agent can comprise nystatin. In 15 infective agent can be obtained from a bulk source. In an an aspect, a disclosed kit can comprise mupirocin and aspect, the additional anti-infective agent can be an anti nystatin. bacterial agent. Anti-bacterial agents are known to the art a. Mupirocin and/or Itraconazole and discussed Supra. In an aspect, the additional anti Disclosed herein is a kit, comprising: one or more con infective agent can be an anti-fungal agent. Anti-fungal tainers comprising a therapeutically effective amount of agents are known to the art and discussed Supra. mupirocin and one or more containers comprising a thera In an aspect, a disclosed kit can comprise a plurality peutically effective amount of itraconazole. Disclosed herein containers of the mupirocin. For example, in an aspect, a is a kit, comprising: one or more containers comprising a disclosed kit can comprise about 30 containers of the therapeutically effective amount of mupirocin and one or mupirocin, or about 60 containers of the mupirocin, or about more containers comprising a therapeutically effective 25 90 containers of the mupirocin. In an aspect, a disclosed kit amount of itraconazole, and instructions for using the mupi can comprise 120 containers of the mupirocin. In an aspect, rocin and the itraconazole. the kit can comprise an amount that the skilled person In an aspect, the kit can comprise a foot bath. In an aspect, considers a monthly supply of the mupirocin. a foot bath can comprise a mechanical agitation agent to In an aspect, the kit can comprise a plurality of containers mechanically agitate the enclosed water, a heating agent to 30 of the itraconazole. For example, in an aspect, a disclosed kit heat the enclosed water, or both. Mechanical agitation agents can comprise about 30 containers of the itraconazole, or and/or means to agitate water within a compartment are about 60 containers of the itraconazole, or about 90 con known to the art. In an aspect, a mechanical agitation agent tainers of the itraconazole. In an aspect, a disclosed kit can can be a motorized agitation agent. In an aspect, an agitation comprise 120 containers or more of the itraconazole. In an agent or an agitator can be coupled to both a motor and the 35 aspect, the kit can comprise an amount that the skilled foot bath. Motors and agitators are known to the art. In an person considers a monthly supply of the itraconazole. aspect, mechanical agitation can serve to distribute the Disclosed herein is a kit, comprising: one or more con mupirocin and the itraconazole or both throughout the water tainers comprising a therapeutically effective amount of contained within the foot bath. Heating agents and/or means mupirocin, one or more containers comprising a therapeu to heat water in a compartment are known to the art. 40 tically effective amount of itraconazole, a foot bath, and In an aspect, the kit can comprise one or more funnels. In instructions for using the mupirocin and the itraconazole. an aspect, the kit can comprise one or more mixing con Disclosed herein is a kit, comprising: one or more containers tainers. In an aspect, the kit can comprise one or more comprising a therapeutically effective amount of mupirocin, Scoops. one or more containers comprising a therapeutically effec In an aspect, the kit can comprise a diluent for the 45 tive amount of itraconazole, a foot bath, one or more Scoops, mupirocin. In an aspect, the kit can comprise a diluent for one or more mixing containers, a diluent, and instructions the itraconazole. In an aspect, the diluent can comprise for using the mupirocin and the itraconazole. Sodium hypochlorite. In an aspect, the diluent can comprise b. Azithromycin and/or Fluconazole Dakin's solution. In an aspect, the diluent for the mupirocin Disclosed herein is a kit, comprising: one or more con is the same as the diluent for the itraconazole. In an aspect, 50 tainers comprising a therapeutically effective amount of the diluent for the mupirocin is different than the diluent for azithromycin and one or more containers comprising a the itraconazole. therapeutically effective amount of fluconazole. Disclosed In an aspect, a disclosed kit can comprise one or more herein is a kit, comprising: one or more containers compris containers comprising an excipient base powder comprising ing a therapeutically effective amount of azithromycin, one a blend of micronized Xylitol and poloxamers. In an aspect, 55 or more containers comprising a therapeutically effective the excipient base powder can comprise LoxasperseTM amount of fluconazole, and instructions for using the mupi excipient base powder. In an aspect, the excipient base rocin and the itraconazole. powder can comprise LoxasperseTM excipient base powder In an aspect, the kit can comprise a foot bath. In an aspect, and XyliFosTM excipient base powder. In an aspect, an a foot bath can comprise a mechanical agitation agent to excipient base powder can be obtained from a bulk source. 60 mechanically agitate the enclosed water, a heating agent to In an aspect, the mupirocin can be a dry powder. In an heat the enclosed water, or both. Mechanical agitation agents aspect, the mupirocin can be an ointment. The mupirocin can and/or means to agitate water within a compartment are be pure or substantially pure. The mupirocin can be obtained known to the art. In an aspect, a mechanical agitation agent from a bulk source. In an aspect, the itraconazole can be a can be a motorized agitation agent. In an aspect, an agitation dry powder. In an aspect, the itraconazole can be an oint 65 agent or an agitator can be coupled to both a motor and the ment. The itraconazole can be pure or Substantially pure. foot bath. Motors and agitators are known to the art. In an The itraconazole can be obtained from a bulk source. aspect, mechanical agitation can serve to distribute the US 9,707,229 B2 61 62 azithromycin and the fluconazole or both throughout the aspect, the kit can comprise an amount that the skilled water contained within the foot bath. Heating agents and/or person considers a monthly supply of the fluconazole. means to heat water in a compartment are known to the art. Disclosed herein is a kit, comprising: one or more con In an aspect, the kit can comprise one or more funnels. In tainers comprising a therapeutically effective amount of an aspect, the kit can comprise one or more mixing con azithromycin, one or more containers comprising a thera tainers. In an aspect, the kit can comprise one or more peutically effective amount of fluconazole, a foot bath, and Scoops. instructions for using the mupirocin and the itraconazole. In an aspect, the kit can comprise a diluent for the Disclosed herein is a kit, comprising: one or more con azithromycin. In an aspect, the kit can comprise a diluent for tainers, each comprising a therapeutically effective amount 10 of azithromycin, one or more containers comprising a thera the fluconazole. In an aspect, the diluent can comprise peutically effective amount of fluconazole, a foot bath, one Sodium hypochlorite. In an aspect, the diluent can comprise or more scoops, one or more mixing containers, a diluent, Dakin's solution. In an aspect, the diluent for the azithro and instructions for using the azithromycin and the flucon mycin is the same as the diluent for the fluconazole. In an azole. aspect, the diluent for the azithromycin is different than the 15 c. Mupirocin and/or Nystatin diluent for the fluconazole. Disclosed herein is a kit, comprising: one or more con In an aspect, a disclosed kit can comprise one or more tainers or tubes comprising a therapeutically effective containers comprising an excipient base powder comprising amount of mupirocin and one or more containers comprising a blend of micronized Xylitol and poloxamers. In an aspect, a therapeutically effective amount of nystatin. Disclosed the excipient base powder can comprise LoxasperseTM herein is a kit, comprising: one or more containers or tubes excipient base powder. In an aspect, the excipient base comprising a therapeutically effective amount of mupirocin, powder can comprise LoxasperseTM excipient base powder one or more containers comprising a therapeutically effec and XyliFosTM excipient base powder. In an aspect, an tive amount of nyStatin, and instructions for using the excipient base powder can be obtained from a bulk source. mupirocin and the nyStatin. In an aspect, the azithromycin can be a dry powder. In an 25 In an aspect, the kit can comprise a foot bath. In an aspect, aspect, the azithromycin can be an ointment. The azithro a foot bath can comprise a mechanical agitation agent to mycin can be pure or Substantially pure. The azithromycin mechanically agitate the enclosed water, a heating agent to can be obtained from a bulk source. In an aspect, the heat the enclosed water, or both. Mechanical agitation agents fluconazole can be a dry powder. In an aspect, the flucon and/or means to agitate water within a compartment are azole can be an ointment. The fluconazole can be pure or 30 known to the art. In an aspect, a mechanical agitation agent substantially pure. The fluconazole can be obtained from a can be a motorized agitation agent. In an aspect, an agitation bulk source. agent or an agitator can be coupled to both a motor and the In an aspect, the amount of the azithromycin used in a foot bath. Motors and agitators are known to the art. In an disclosed kit compared to the amount of the fluconazole aspect, mechanical agitation can serve to distribute the used can be from about 1:4 to about 4:1. In an aspect, the 35 mupirocin and the nystatin or both throughout the water amount of the azithromycin used in a disclosed kit compared contained within the foot bath. Heating agents and/or means to the amount of the fluconazole used can be about 1:1. In to heat water in a compartment are known to the art. an aspect, the amount of the azithromycin used in a dis In an aspect, the kit can comprise one or more funnels. In closed kit compared to the amount of the fluconazole used an aspect, the kit can comprise one or more mixing con can be about 1.25:1. 40 tainers. In an aspect, the kit can comprise one or more In an aspect, a disclosed kit can comprise one or more scoops. In an aspect, the kit can comprise one or more keys. containers comprising one or more additional anti-infective In an aspect, the kit can comprise a diluent for the agents. In an aspect, the additional anti-infective agent can mupirocin. In an aspect, the kit can comprise a diluent for be a dry powder. In an aspect, the additional anti-infective the nystatin. In an aspect, the diluent can comprise sodium agent can be an ointment. The additional anti-infective agent 45 hypochlorite. In an aspect, the diluent can comprise Dakin's can be pure or Substantially pure. The additional anti Solution. In an aspect, the diluent for the mupirocin is the infective agent can be obtained from a bulk source. In an same as the diluent for the nyStatin. In an aspect, the diluent aspect, the additional anti-infective agent can be an anti for the mupirocin is different than the diluent for the bacterial agent. Anti-bacterial agents are known to the art nystatin. and discussed Supra. In an aspect, the additional anti 50 In an aspect, a disclosed kit can comprise one or more infective agent can be an anti-fungal agent. Anti-fungal containers comprising an excipient base powder comprising agents are known to the art and discussed Supra. a blend of micronized Xylitol and poloxamers. In an aspect, In an aspect, a disclosed kit can comprise a plurality the excipient base powder can comprise LoxasperseTM containers of the azithromycin. For example, in an aspect, a excipient base powder. In an aspect, the excipient base disclosed kit can comprise about 30 containers of the 55 powder can comprise LoxasperseTM excipient base powder azithromycin, or about 60 containers of the azithromycin, or and XyliFosTM excipient base powder. In an aspect, an about 90 containers of the azithromycin. In an aspect, a excipient base powder can be obtained from a bulk source. disclosed kit can comprise 120 containers of the azithromy In an aspect, the mupirocin can be a dry powder. The cin. In an aspect, the kit can comprise an amount that the mupirocin can be pure or Substantially pure. In an aspect, the skilled person considers a monthly supply of the azithro 60 mupirocin can be obtained from a bulk source. In an aspect, mycin. the mupirocin can be an ointment. In an aspect, the mupi In an aspect, the kit can comprise a plurality of containers rocin can be a 2% ointment. In an aspect, the mupirocin can of the fluconazole. For example, in an aspect, a disclosed kit be provided in a tube. For example, in an aspect, the can comprise about 30 containers of the fluconazole, or mupirocin can be provided in a 22 gram tube. In an aspect, about 60 containers of the fluconazole, or about 90 contain 65 the nystatin can be a dry powder. In an aspect, the nystatin ers of the fluconazole. In an aspect, a disclosed kit can can be an ointment. The nyStatin can be pure or Substantially comprise 120 containers or more of the fluconazole. In an pure. In an aspect, the nyStatin can be obtained from a bulk US 9,707,229 B2 63 64 Source. In an aspect, the nyStatin can be provided in a base powder can comprise obtaining a bulk source of the container. For example, in an aspect, the nystatin can be anti-bacterial agent, a bulk source of the anti-fungal agent, provided in 15 gram container. a bulk source of the excipient base powder, or a combination In an aspect, the kit can comprise a plurality of containers thereof. or tubes of mupirocin. For example, in an aspect, a disclosed In an aspect, the excipient base powder can comprise kit can comprise about 30 containers or tubes of mupirocin, LoxasperseTM excipient base powder. In an aspect, the or about 60 containers or tubes of mupirocin, or about 90 excipient base powder can comprise Loxasperse M excipient containers or tubes of mupirocin. In an aspect, a disclosed kit base powder and XyliFosTM excipient base powder. can comprise 120 containers or tubes of mupirocin or more. In an aspect, the anti-bacterial agent can comprise from In an aspect, the kit can comprise an amount that the skilled 10 about 10% to about 40% w/w of the compounded compo person considers a monthly supply of the mupirocin. sition. In an aspect, the anti-bacterial agent can comprise In an aspect, the kit can comprise a plurality of containers from about 15% to about 35% w/w of the compounded of nystatin. For example, in an aspect, a disclosed kit can composition. In an aspect, the anti-bacterial agent can com comprise about 30 containers of nystatin, or about 60 prise from about 20% to about 30% w/w of the compounded containers of nyStatin, or about 90 containers of nystatin. In 15 composition. In an aspect, the anti-bacterial agent can com an aspect, a disclosed kit can comprise 120 containers or prise about 25% w/w of the compounded composition. more of nyStatin. In an aspect, the kit can comprise an In an aspect, the anti-fungal agent can comprise from amount that the skilled person considers a monthly supply of about 10% to about 40% w/w of the compounded compo the nystatin. sition. In an aspect, the anti-fungal agent can comprise from In an aspect, a disclosed kit can comprise one or more about 15% to about 35% w/w of the compounded compo containers comprising one or more additional anti-infective sition. In an aspect, the anti-fungal agent can comprise from agents. In an aspect, the additional anti-infective agent can about 20% to about 30% w/w of the compounded compo be a dry powder. In an aspect, the additional anti-infective sition. In an aspect, the anti-fungal agent can comprise about agent can be an ointment. The additional anti-infective agent 25% w/w of the compounded composition. can be pure or Substantially pure. The additional anti 25 In an aspect, the ratio of the anti-bacterial agent to the infective agent can be obtained from a bulk source. In an anti-fungal agent in the compounded composition can be aspect, the additional anti-infective agent can be an anti from about 1:4 to about 4:1. In an aspect, the ratio of the bacterial agent. Anti-bacterial agents are known to the art anti-bacterial agent to the anti-fungal agent can be about 1:1. and discussed Supra. In an aspect, the additional anti In an aspect, the ratio of the anti-bacterial agent to the infective agent can be an anti-fungal agent. Anti-fungal 30 anti-fungal agent can be about 1.25:1. See, e.g., Table 2. agents are known to the art and discussed Supra. In an aspect, the anti-bacterial agent can comprise Disclosed herein is a kit, comprising: one or more con afenide, amikacin, amoxicillin, ampicillin, arsphenamine, tainers or tubes comprising a therapeutically effective azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra amount of mupirocin, one or more containers comprising a cin, carbacephem (loracarbef), carbenicillin, cefaclor, therapeutically effective amount of nystatin, a foot bath, and 35 cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi instructions for using the mupirocin and the nystatin. Dis toren, cefepime, cefixime, cefoperaZone, cefotaxime, closed herein is a kit, comprising: one or more containers or cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, tubes comprising a therapeutically effective amount of ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha mupirocin, one or more containers comprising a therapeu lexin, chloramphenicol, chlorhexidine, ciprofloxacin, tically effective amount of nystatin, a foot bath, one or more 40 clarithromycin, clavulanic acid, clindamycin, cloxacillin, scoops, a mixing container, one or more keys, a diluent, and colimycin, colistimethate teicoplanin, colistin, demeclocy instructions for using the mupirocin, and the nystatin. cline, dicloxacillin, dirithromycin, doripenem, doxycycline, A. Methods of Making a Compounded Composition efprozil, enoxacin, ertapenem, erythromycin, ethambutol, Disclosed herein is a method of making a compounded flucloxacillin, fosfomycin, furazolidone, gatifloxacin, composition comprising an anti-bacterial agent and an anti 45 geldanamycin, gentamicin, grepafloxacin, herbimycin, imi fungal agent. penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin 1. Compounded Composition Comprising an Anti-Bacterial eZolid, lomefloxacin, meropenem, meticillin, metronidazole, Agent and an Anti-Fungal Agent meZlocillin, minocycline, mitomycin, moxifloxacin, mupi Disclosed herein is a method of making a compounded rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor composition, the method comprising: mixing a therapeuti 50 floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy cally effective amount of an anti-bacterial agent and a cin, penicillin G, penicillin V, piperacillin, pivmecillinam, therapeutically effective amount of an anti-fungal agent with platensimycin, polymyxin B, prontosil, pvampicillin, an excipient base powder comprising a blend of micronized pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam Xylitol and poloxamers to make a homogenous compounded pin, roXithromycin, sparfloxacin, spectinomycin, spiramy composition. 55 cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox In an aspect, the compounded composition can be a dry azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, powder formulation. Sultamicillin, tellithromycin, tetracycline, thiamphenicol, In an aspect, the anti-bacterial agent can be a dry powder. ticarcillin, tobramycin, trimethoprim, trimethoprim-sul In an aspect, the anti-bacterial agent can be an ointment. The famethoxazole, troleandomycin, trovafloxacin, or a combi anti-bacterial agent can be pure or Substantially pure. In an 60 nation thereof. aspect, the anti-fungal agent can be a dry powder. In an In an aspect of a disclosed method, the anti-bacterial agent aspect, the anti-fungal agent can be an ointment. The anti can comprise mupirocin. In an aspect of a disclosed method, fungal agent can be pure or Substantially pure. the anti-bacterial agent can comprise azithromycin. In an aspect, the method can comprise obtaining the In an aspect, the anti-fungal agent can comprise aba anti-bacterial agent, the anti-fungal agent, the excipient base 65 fungin, albaconazole, amorolfin, amphotericin b, anidula powder, or a combination thereof. In an aspect, obtaining the fungin, bifonazole, butenafine, butoconazole, candicidin, anti-bacterial agent, the anti-fungal agent, or the excipient caspofungin, ciclopiroX, clotrimazole, econazole, fenticon US 9,707,229 B2 65 66 azole, filipin, fluconazole, flucytosine, griseofulvin, halo In an aspect, the mupirocin can comprise from about 10% progin, hamycin, isavuconazole, isoconazole, itraconazole, to about 40% w/w of the compounded composition. In an ketoconazole, micafungin, miconazole, naftifine, natamycin, aspect, the mupirocin can comprise from about 15% to about nystatin, omoconazole, oxiconazole, polygodial, posacon 35% w/w of the compounded composition. In an aspect, the azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, mupirocin can comprise from about 20% to about 30% w/w terbinafine, terconazole, tioconazole, tolnaftate, undecylenic of the compounded composition. In an aspect, the mupirocin acid, Voriconazole, or a combination thereof. can comprise about 25% w/w of the compounded compo In an aspect of a disclosed method, the anti-fungal agent sition. can comprise itraconazole. In an aspect of a disclosed In an aspect, the itraconazole can comprise from about 10 10% to about 40% w/w of the compounded composition. In method, the anti-fungal agent can comprise fluconazole. In an aspect, the itraconazole can comprise from about 15% to an aspect of a disclosed method, the anti-fungal agent can about 35% w/w of the compounded composition. In an comprise nystatin. aspect, the itraconazole can comprise from about 20% to In an aspect of a disclosed method, the anti-bacterial agent about 30% w/w of the compounded composition. In an can comprise mupirocin and the anti-fungal agent can com 15 aspect, the itraconazole can comprise about 25% w/w of the prise itraconazole. In an aspect of a disclosed method, the compounded composition. anti-bacterial agent can comprise azithromycin and the In an aspect, the ratio of the mupirocin to the itraconazole anti-fungal agent can comprise fluconazole. In an aspect of in the compounded composition can be from about 1:4 to a disclosed method, the anti-bacterial agent can comprise about 4:1. In an aspect, the ratio of the mupirocin to the mupirocin and the anti-fungal agent can comprise nystatin. itraconazole can be about 1:1. In an aspect, the ratio of the In an aspect, the method can comprise mixing a thera mupirocinto the itraconazole can be about 1.25:1. See, e.g., peutically effective amount of an additional anti-infective Table 2. agent with the compounded composition. In an aspect, the In an aspect, the method can comprise mixing a thera additional anti-infective agent can be a dry powder. In an peutically effective amount of an additional anti-infective aspect, the additional anti-infective agent can be an oint 25 agent with the compounded composition. ment. The additional anti-infective can be pure or substan In an aspect, the additional anti-infective agent can be a tially pure. The additional anti-infective agent can be dry powder. In an aspect, the additional anti-infective agent obtained from a bulk source. can be an ointment. The additional anti-infective agent can In an aspect, additional the anti-infective agent can be an be pure or substantially pure. The additional anti-infective anti-bacterial agent. Anti-bacterial agents are known to the 30 agent can be obtained from a bulk source. In an aspect, the art and discussed Supra. In an aspect, the additional anti additional anti-infective agent can be an anti-bacterial agent. infective agent can be an anti-fungal agent. Anti-fungal Anti-bacterial agents are known to the art and discussed agents are known to the art and discussed Supra. In an aspect, Supra. In an aspect, the additional anti-infective agent can be the method can comprise obtaining the additional anti an anti-fungal agent. Anti-fungal agents are known to the art infective agent. In an aspect, obtaining the additional anti 35 and discussed Supra. In an aspect, the method can comprise infective agent can comprise obtaining a bulk source of the obtaining the additional anti-infective agent. In an aspect, anti-infective agent. obtaining the additional anti-infective agent can comprise In an aspect, the method can comprise packaging the obtaining a bulk source of the anti-infective agent. compounded composition into a container and sealing the In an aspect, the method can comprise packaging the container. In an aspect, the method can comprise sterilizing 40 compounded composition into a container and sealing the the container comprising the compounded composition. container. In an aspect, the method can comprise sterilizing 2. Compounded Composition Comprising Mupirocin and/or the container comprising the compounded composition Itraconazole comprising mupirocin and itraconazole. Disclosed herein is a method of making a compounded Disclosed herein is a method of making a compounded composition, the method comprising: mixing a therapeuti 45 composition, the method comprising: mixing a therapeuti cally effective amount of mupirocin and a therapeutically cally effective amount of mupirocin and a therapeutically effective amount of itraconazole with an excipient base effective amount of an anti-fungal agent with an excipient powder comprising a blend of micronized Xylitol and poloX base powder comprising a blend of micronized Xylitol and amers to make a homogenous compounded composition. poloxamers to make a homogenous compounded composi In an aspect, the compounded composition can be a dry 50 tion. powder formulation. Disclosed herein is a method of making a compounded In an aspect, the mupirocin can be a dry powder. In an composition, the method comprising: mixing a therapeuti aspect, the mupirocin can be an ointment. The mupirocin can cally effective amount of an anti-bacterial agent and a be pure or Substantially pure. In an aspect, the itraconazole therapeutically effective amount of itraconazole with an can be a dry powder. In an aspect, the itraconazole can be an 55 excipient base powder comprising a blend of micronized ointment. The itraconazole can be pure or Substantially pure. Xylitol and poloxamers to make a homogenous compounded In an aspect, the method can comprise obtaining the composition. mupirocin, the itraconazole, the excipient base powder, or a 3. Compounded Composition Comprising Azithromycin combination thereof. In an aspect, obtaining the mupirocin, and/or Fluconazole the itraconazole, or the excipient base powder can comprise 60 Disclosed herein is a method of making a compounded obtaining a bulk source of the mupirocin, a bulk source of composition, the method comprising: mixing a therapeuti the itraconazole, a bulk source of the excipient base powder, cally effective amount of azithromycin and a therapeutically or obtaining a combination thereof. effective amount of fluconazole with an excipient base In an aspect, the excipient base powder can comprise powder comprising a blend of micronized Xylitol and poloX LoxasperseTM excipient base powder. In an aspect, the 65 amers to make a homogenous compounded composition. excipient base powder can comprise Loxasperse M excipient In an aspect, the compounded composition can be a dry base powder and XyliFosTM excipient base powder. powder formulation. In an aspect, the azithromycin can be a US 9,707,229 B2 67 68 dry powder. In an aspect, the azithromycin can be an base powder comprising a blend of micronized Xylitol and ointment. The azithromycin can be pure or Substantially poloxamers to make a homogenous compounded composi pure. In an aspect, the fluconazole can be a dry powder. In tion. an aspect, the fluconazole can be an ointment. The flucon Disclosed herein is a method of making a compounded azole can be pure or Substantially pure. composition, the method comprising: mixing a therapeuti In an aspect, the method can comprise obtaining the cally effective amount of an anti-bacterial agent and a azithromycin, the fluconazole, the excipient base powder, or therapeutically effective amount of fluconazole with an a combination thereof. In an aspect, obtaining the azithro excipient base powder comprising a blend of micronized mycin, the fluconazole, or the excipient base powder can Xylitol and poloxamers to make a homogenous compounded comprise obtaining a bulk source of the azithromycin, a bulk 10 composition. source of the fluconazole, a bulk source of the excipient base Disclosed herein is a method of making a compounded powder, or obtaining a combination thereof. composition, the method comprising: mixing a therapeuti In an aspect, the excipient base powder can comprise cally effective amount of azithromycin and a therapeutically LoxasperseTM excipient base powder. In an aspect, the effective amount of fluconazole with an excipient base excipient base powder can comprise Loxasperse M excipient 15 powder comprising a blend of micronized Xylitol and poloX base powder and XyliFosTM excipient base powder. amers to make a homogenous compounded composition, In an aspect, the azithromycin can comprise from about and encapsulating the homogenous compounded composi 10% to about 60% w/w of the compounded composition. In tion in one or more capsules. an aspect, the azithromycin can comprise from about 20% to 4. Compounded Composition Comprising Mupirocin and/or about 50% w/w of the compounded composition. In an Nystatin aspect, the azithromycin can comprise from about 30% to Disclosed herein is a method of making a compounded about 40% w/w of the compounded composition. In an composition, the method comprising: mixing a therapeuti aspect, the azithromycin can comprise about 25% w/w of the cally effective amount of mupirocin and a therapeutically compounded composition. In an aspect, the azithromycin effective amount of nystatin with an excipient base powder can comprise about 50% w/w of the compounded compo 25 comprising a blend of micronized Xylitol and poloxamers to sition. make a homogenous compounded composition. In an aspect, the fluconazole can comprise from about In an aspect, the compounded composition can be a dry 10% to about 60% w/w of the compounded composition. In powder formulation. an aspect, the fluconazole can comprise from about 20% to In an aspect, the mupirocin can be a dry powder. The about 50% w/w of the compounded composition. In an 30 mupirocin can be pure or Substantially pure. In an aspect, the aspect, the fluconazole can comprise from about 30% to mupirocin can be an ointment. In an aspect, the mupirocin about 40% w/w of the compounded composition. In an can be a 2% ointment. In an aspect, the nystatin can be a dry aspect, the fluconazole can comprise about 25% w/w of the powder. In an aspect, the nyStatin can be an ointment. The compounded composition. In an aspect, the fluconazole can nystatin can be pure or Substantially pure. comprise about 50% w/w of the compounded composition. 35 In an aspect, the method can comprise obtaining the In an aspect, the ratio of the azithromycin to the flucon mupirocin, the nyStatin, the excipient base powder, or a azole in the compounded composition can be from about 1:4 combination thereof. In an aspect, obtaining the mupirocin, to about 4:1. In an aspect, the ratio of the azithromycinto the the nyStatin, or the excipient base powder can comprise fluconazole can be about 1:1. In an aspect, the ratio of the obtaining a bulk source of the mupirocin, a bulk source of azithromycin to the fluconazole can be about 1.25:1. See, 40 the nystatin, a bulk source of the excipient base powder, or e.g., Table 3. obtaining a combination thereof. In an aspect, the method can comprise mixing a thera In an aspect, the excipient base powder can comprise peutically effective amount of an additional anti-infective LoxasperseTM excipient base powder. In an aspect, the agent with the compounded composition. In an aspect, the excipient base powder can comprise Loxasperse M excipient additional anti-infective agent can be a dry powder. In an 45 base powder and XyliFosTM excipient base powder. aspect, the additional anti-infective agent can be an oint In an aspect, the mupirocin can comprise from about 10% ment. The additional anti-infective agent can be pure or to about 40% w/w of the compounded composition. In an Substantially pure. The additional anti-infective agent can be aspect, the mupirocin can comprise from about 15% to about obtained from a bulk source. 35% w/w of the compounded composition. In an aspect, the In an aspect, the additional anti-infective agent can be an 50 mupirocin can comprise from about 20% to about 30% w/w anti-bacterial agent. Anti-bacterial agents are known to the of the compounded composition. In an aspect, the mupirocin art and discussed Supra. In an aspect, the additional anti can comprise about 25% w/w of the compounded compo infective agent can be an anti-fungal agent. Anti-fungal sition. agents are known to the art and discussed Supra. In an aspect, In an aspect, the nystatin can comprise from about 10% to the method can comprise obtaining the additional anti 55 about 40% w/w of the compounded composition. In an infective agent. In an aspect, obtaining the additional anti aspect, the nyStatin can comprise from about 15% to about infective agent can comprise obtaining a bulk source of the 35% w/w of the compounded composition. In an aspect, the anti-infective agent. nystatin can comprise from about 20% to about 30% w/w of In an aspect, the method can comprise packaging the the compounded composition. In an aspect, the nystatin can compounded composition into a container and sealing the 60 comprise about 25% w/w of the compounded composition. container. In an aspect, the method can comprise sterilizing In an aspect, the ratio of the mupirocin to the nystatin in the container comprising the compounded composition the compounded composition can be from about 1:4 to about comprising azithromycin and fluconazole. 4:1. In an aspect, the ratio of the mupirocin the nystatin can Disclosed herein is a method of making a compounded be about 1:1. In an aspect, the ratio of the mupirocinto the composition, the method comprising: mixing a therapeuti 65 nystatin can be about 1.25:1. cally effective amount of azithromycin and a therapeutically In an aspect, the method can comprise mixing a thera effective amount of an anti-fungal agent with an excipient peutically effective amount of an additional anti-infective US 9,707,229 B2 69 70 agent with the compounded composition. In an aspect, the that affects at least part of one or both feet. In an aspect, the additional anti-infective agent can be a dry powder. In an Subject has been diagnosed with or is suspected of having a aspect, the additional anti-infective agent can be an oint bacterial infection and a fungal infection that affect at least ment. The additional anti-infective agent can be pure or part of one or both feet. Substantially pure. The additional anti-infective agent can be 5 In an aspect, the Subject can have diabetes. In an aspect, obtained from a bulk source. the Subject can be obese. In an aspect, the Subject can have In an aspect, the additional anti-infective agent can be an poor blood flow. In an aspect, the Subject can routinely wear anti-bacterial agent. Anti-bacterial agents are known to the thick Socks. In an aspect, the Subject can routinely wear art and discussed Supra. In an aspect, the additional anti heavy boots. infective agent can be an anti-fungal agent. Anti-fungal 10 In an aspect, contacting can comprise placing at least part agents are known to the art and discussed Supra. In an aspect, of one or both feet of the subject in the foot bath. In an the method can comprise obtaining the additional anti aspect, contacting can comprise placing at least part of one infective agent. In an aspect, obtaining the additional anti or both feet of the subject in the foot bath for about 5 to infective agent can comprise obtaining a bulk source of the about 15 minutes. In an aspect, contacting can comprise anti-infective agent. 15 placing at least part of one or both feet of the subject in the In an aspect, the method can comprise packaging the foot bath for about 10 minutes. compounded composition into a container and sealing the In an aspect, the method can comprise repeating steps container. In an aspect, the method can comprise sterilizing (i)-(iii) daily. In an aspect, the method can comprise repeat the container comprising the compounded composition ing steps (i)-(iii) daily until the bacterial infection or Sus comprising mupirocin and nystatin. 2O pected bacterial infection can be eradicated. In an aspect, the Disclosed herein is a method of making a compounded method can comprise repeating steps (i)-(iii) daily until the composition, the method comprising: mixing a therapeuti fungal infection or Suspected fungal infection can be eradi cally effective amount of mupirocin and a therapeutically cated. In an aspect, the method can comprise repeating steps effective amount of an anti-fungal agent with an excipient (i)-(iii) daily until the infection or the suspected infection base powder comprising a blend of micronized Xylitol and 25 can be eradicated. poloxamers to make a homogenous compounded composi In an aspect, the method can comprise heating the water tion. contained within the foot bath. Disclosed herein is a method of making a compounded In an aspect, a foot bath can comprise a mechanical composition, the method comprising: mixing a therapeuti agitation agent to mechanically agitate the enclosed water, a cally effective amount of an anti-bacterial agent and a 30 heating agent to heat the enclosed water, or both. Mechani therapeutically effective amount of nyStatin with an excipi cal agitation agents and/or means to agitate water within a ent base powder comprising a blend of micronized xylitol compartment are known to the art. In an aspect, a mechani and poloxamers to make a homogenous compounded com cal agitation agent can be a motorized agitation agent. In an position. aspect, an agitation agent or an agitator can be coupled to B. Methods of Treating of Preventing an Infection Using a 35 both a motor and the foot bath. Motors and agitators are Compounded Composition known to the art. In an aspect, mechanical agitation can Disclosed herein is a method of treating or preventing an serve to distribute the compounded composition throughout infection, the method comprising: (i) adding a compounded the water contained within the foot bath. Heating agents composition to water contained within a foot bath; (ii) and/or means to heat water in a compartment are known to agitating the water contained within the foot bath; and (iii) 40 the art. contacting the agitated water with at least a part of one or In an aspect, the compounded composition can comprise both feet of a subject. Disclosed herein is a method of an excipient base powder comprising a blend of micronized treating or preventing an infection, the method comprising: Xylitol and poloxamers. In an aspect, the excipient base (i) mixing a compounded composition with a diluent to powder can comprise LoxasperseTM excipient base powder. create a solution; (ii) adding the solution to water contained 45 In an aspect, the excipient base powder can comprise within a foot bath; (iii) agitating the water contained within LoxasperseTM excipient base powder and XyliFosTM excipi the foot bath; and (iv) contacting the agitated water with at ent base powder. In an aspect, an excipient base powder can least part of one or both feet of a subject. be obtained from a bulk source. 1. Compounded Composition Comprising an Anti-Bacterial In an aspect, the compounded composition can be a dry Agent and an Anti-Fungal Agent 50 powder formulation. In an aspect, the anti-bacterial agent Disclosed herein is a method of treating or preventing an can be obtained from a bulk source. The anti-bacterial agent infection, the method comprising: (i) adding a compounded can be pure or Substantially pure. In an aspect, the anti composition comprising an anti-bacterial agent and an anti fungal agent can be obtained from a bulk source. The fungal agent to water contained within a foot bath; (ii) anti-fungal agent can be pure or Substantially pure. agitating the water contained within the foot bath; and (iii) 55 In an aspect, the anti-bacterial agent can comprise from contacting the agitated water with at least a part of one or about 10% to about 40% w/w of the compounded compo both feet of a subject. sition. In an aspect, the anti-bacterial agent can comprise In an aspect, the method can comprise adding a diluent to from about 15% to about 35% w/w of the compounded the water contained in the foot bath. In an aspect, the diluent composition. In an aspect, the anti-bacterial agent can com can comprise Sodium hypochlorite. In an aspect, the diluent 60 prise from about 20% to about 30% w/w of the compounded can comprise Dakin's Solution. In an aspect, the amount of composition. In an aspect, the anti-bacterial agent can com diluent can be about 3.75 mL to about 60 mL. In an aspect, prise about 25% w/w of the compounded composition. the amount of diluent can be about 15 mL. In an aspect, the anti-fungal agent can comprise from In an aspect, the Subject has been diagnosed with or is about 10% to about 40% w/w of the compounded compo Suspected of having a bacterial infection that affects at least 65 sition. In an aspect, the anti-fungal agent can comprise from part of one or both feet. In an aspect, the subject has been about 15% to about 35% w/w of the compounded compo diagnosed with or is Suspected of having a fungal infection sition. In an aspect, the anti-fungal agent can comprise from US 9,707,229 B2 71 72 about 20% to about 30% w/w of the compounded compo aspect, the additional anti-infective agent can be a dry sition. In an aspect, the anti-fungal agent can comprise about powder. In an aspect, the additional anti-infective agent can 25% w/w of the compounded composition. be an ointment. The additional anti-infective agent can be In an aspect, the ratio of the anti-bacterial agent to the pure or substantially pure. The additional anti-infective anti-fungal agent in the compounded composition can be agent can be obtained from a bulk source. In an aspect, the from about 1:4 to about 4:1. In an aspect, the ratio of the additional anti-infective agent can be an anti-bacterial agent. anti-bacterial agent to the anti-fungal agent can be about 1:1. Anti-bacterial agents are known to the art and discussed In an aspect, the ratio of the anti-bacterial agent to the Supra. In an aspect, the additional anti-infective agent can be anti-fungal agent can be about 1.25:1. See, e.g., Table 1. an anti-fungal agent. Anti-fungal agents are known to the art In an aspect, the anti-bacterial agent can comprise 10 and discussed Supra. afenide, amikacin, amoxicillin, amplicillin, arsphenamine, In an aspect, the method can comprise orally administer azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra ing to the Subject a pharmaceutical composition comprising cin, carbacephem (loracarbef), carbenicillin, cefaclor, an anti-bacterial agent. In an aspect, the method can com cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi prise orally administering to the Subject a pharmaceutical toren, cefepime, cefixime, cefoperaZone, cefotaxime, 15 composition comprising an anti-fungal agent. In an aspect, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, the method can comprise orally administering to the Subject ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha a pharmaceutical composition comprising an anti-bacterial lexin, chloramphenicol, chlorhexidine, ciprofloxacin, agent and a pharmaceutical composition comprising an clarithromycin, clavulanic acid, clindamycin, cloxacillin, anti-fungal agent. In an aspect, the method can comprise colimycin, colistimethate teicoplanin, colistin, demeclocy orally administering to the Subject a pharmaceutical com cline, dicloxacillin, dirithromycin, doripenem, doxycycline, position comprising an anti-bacterial agent and a pharma efprozil, enoxacin, ertapenem, erythromycin, ethambutol, ceutical composition comprising an anti-fungal agent. flucloxacillin, fosfomycin, furazolidone, gatifloxacin, In an aspect, a disclosed compounded composition com geldanamycin, gentamicin, grepafloxacin, herbimycin, imi prising an anti-bacterial agent and an anti-fungal agent can penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin 25 be encapsulated in one or more capsules. In an aspect, the eZolid, lomefloxacin, meropenem, meticillin, metronidazole, one or more capsules comprising the compounded compo meZlocillin, minocycline, mitomycin, moxifloxacin, mupi sition can be added to the water contained within the foot rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor bath. In an aspect, the one or more capsules can disintegrate floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy and the compounded composition can be dissolved in the cin, penicillin G, penicillin V, piperacillin, pivmecillinam, 30 water contained within the foot bath. In an aspect, a subject platensimycin, polymyxin B, prontosil, pvampicillin, can open or break apart the one or more capsule and pour the pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam contents of the opened or broken capsules into the water pin, roXithromycin, sparfloxacin, spectinomycin, spiramy contained within a foot bath. cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox In an aspect, a disclosed method can comprise emptying azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, 35 the water from the foot bath. In an aspect, a disclosed Sultamicillin, tellithromycin, tetracycline, thiamphenicol, method can comprise cleaning the foot bath. In an aspect, a ticarcillin, tobramycin, trimethoprim, trimethoprim-sul disclosed method can comprise drying the foot bath. famethoxazole, troleandomycin, trovafloxacin, or a combi In an aspect, a disclosed method can treat or prevent an nation thereof. infection affecting the skin of at least a portion of a subjects In an aspect of a disclosed method, the anti-bacterial agent 40 foot or feet. In an aspect, a disclosed method can treat or can comprise mupirocin. In an aspect of a disclosed method, prevent an infection affecting the nail of at least one toe on the anti-bacterial agent can comprise azithromycin. a subjects foot or feet. In an aspect, the anti-fungal agent can comprise aba Disclosed herein is a method of treating or preventing an fungin, albaconazole, amorolfin, amphotericin b, anidula infection, the method comprising: (i) mixing a compounded fungin, bifonazole, butenafine, butoconazole, candicidin, 45 composition comprising an anti-bacterial agent and an anti caspofungin, ciclopiroX, clotrimazole, econazole, fenticon fungal agent with a diluent to create a solution; (ii) adding azole, filipin, fluconazole, flucytosine, griseofulvin, halo the solution to water contained within a foot bath; (iii) progin, hamycin, isavuconazole, isoconazole, itraconazole, agitating the water contained within the foot bath; and (iv) ketoconazole, micafungin, miconazole, naftifine, natamycin, contacting the agitated water with at least part of one or both nystatin, omoconazole, oxiconazole, polygodial, posacon 50 feet of a subject. azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, In an aspect, the diluent can comprise Sodium hypochlo terbinafine, terconazole, tioconazole, tolnaftate, undecylenic rite. In an aspect, the diluent can comprise Dakin's solution. acid, Voriconazole, or a combination thereof. In an aspect, the amount of diluent can be about 3.75 mL to In an aspect of a disclosed method, the anti-fungal agent about 60 mL. In an aspect, the amount of diluent can be can comprise itraconazole. In an aspect of a disclosed 55 about 15 mL. method, the anti-fungal agent can comprise fluconazole. In In an aspect, the compounded composition and the diluent an aspect of a disclosed method, the a the anti-fungal agent can be mixed in a mixing container. In an aspect, a mixing can comprise nystatin. container can have a pre-determined size that can measure or In an aspect of a disclosed method, the anti-bacterial agent hold a pre-determined amount or Volume. For example, in an can comprise mupirocin and the anti-fungal agent can com 60 aspect, a mixing container can measure or hold an amount prise itraconazole. In an aspect of a disclosed method, the of about 1 ounces to about 30 ounces. In an aspect, the anti-bacterial agent can comprise azithromycin and the mixing container can hold about 6 ounces. In an aspect, the anti-fungal agent can comprise fluconazole. In an aspect of mixing container can hold about 16 ounces. a disclosed method, the anti-bacterial agent can comprise In an aspect, the Subject has been diagnosed with or is mupirocin and the anti-fungal agent can comprise nystatin. 65 Suspected of having a bacterial infection that affects at least In an aspect, a disclosed compounded composition can part of one or both feet. In an aspect, the subject has been comprise one or more additional anti-infective agents. In an diagnosed with or is Suspected of having a fungal infection US 9,707,229 B2 73 74 that affects at least part of one or both feet. In an aspect, the sition. In an aspect, the anti-fungal agent can comprise about Subject has been diagnosed with or is Suspected of having a 25% w/w of the compounded composition. bacterial infection and a fungal infection that affect at least In an aspect, the ratio of the anti-bacterial agent to the part of one or both feet. anti-fungal agent in the compounded composition can be In an aspect, the Subject can have diabetes. In an aspect, from about 1:4 to about 4:1. In an aspect, the ratio of the the Subject can be obese. In an aspect, the Subject can have anti-bacterial agent to the anti-fungal agent can be about 1:1. poor blood flow. In an aspect, the Subject can routinely wear In an aspect, the ratio of the anti-bacterial agent to the thick Socks. In an aspect, the Subject can routinely wear anti-fungal agent can be about 1.25:1. See, e.g., Table 1. heavy boots. In an aspect, the anti-bacterial agent can comprise 10 afenide, amikacin, amoxicillin, amplicillin, arsphenamine, In an aspect, contacting can comprise placing at least part azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra of one or both feet of the subject in the foot bath. In an cin, carbacephem (loracarbef), carbenicillin, cefaclor, aspect, contacting can comprise placing at least part of one cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi or both feet of the subject in the foot bath for about 5 to toren, cefepime, cefixime, cefoperaZone, cefotaxime, about 15 minutes. In an aspect, contacting can comprise 15 cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, placing at least part of one or both feet of the subject in the ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha foot bath for about 10 minutes. lexin, chloramphenicol, chlorhexidine, ciprofloxacin, In an aspect, the method can comprise repeating steps clarithromycin, clavulanic acid, clindamycin, cloxacillin, (i)-(iv) daily. In an aspect, the method can comprise repeat colimycin, colistimethate teicoplanin, colistin, demeclocy ing steps (i)-(iv) daily until the bacterial infection or Sus cline, dicloxacillin, dirithromycin, doripenem, doxycycline, pected bacterial infection can be eradicated. In an aspect, the efprozil, enoxacin, ertapenem, erythromycin, ethambutol, method can comprise repeating steps (i)-(iv) daily until the flucloxacillin, fosfomycin, furazolidone, gatifloxacin, fungal infection or Suspected fungal infection can be eradi geldanamycin, gentamicin, grepafloxacin, herbimycin, imi cated. In an aspect, the method can comprise repeating steps penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin (i)-(iv) daily until the infection or the suspected infection 25 eZolid, lomefloxacin, meropenem, meticillin, metronidazole, can be eradicated. meZlocillin, minocycline, mitomycin, moxifloxacin, mupi In an aspect, the method can comprise heating the water rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor contained within the foot bath. floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy In an aspect, a foot bath can comprise a mechanical cin, penicillin G, penicillin V, piperacillin, pivmecillinam, agitation agent to mechanically agitate the enclosed water, a 30 platensimycin, polymyxin B, prontosil, pvampicillin, heating agent to heat the enclosed water, or both. Mechani pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam cal agitation agents and/or means to agitate water within a pin, roXithromycin, sparfloxacin, spectinomycin, spiramy compartment are known to the art. In an aspect, a mechani cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox cal agitation agent can be a motorized agitation agent. In an azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, aspect, an agitation agent or an agitator can be coupled to 35 Sultamicillin, tellithromycin, tetracycline, thiamphenicol, both a motor and the foot bath. Motors and agitators are ticarcillin, tobramycin, trimethoprim, trimethoprim-sul known to the art. In an aspect, mechanical agitation can famethoxazole, troleandomycin, trovafloxacin, or a combi serve to distribute the solution throughout the water con nation thereof. tained within the foot bath. Heating agents and/or means to In an aspect of a disclosed method, the anti-bacterial agent heat water in a compartment are known to the art. 40 can comprise mupirocin. In an aspect, the compounded composition can be a dry In an aspect of a disclosed method, the anti-bacterial agent powder formulation. In an aspect, the anti-bacterial agent can comprise azithromycin. can be obtained from a bulk source. The anti-bacterial agent In an aspect, the anti-fungal agent can comprise aba can be pure or Substantially pure. In an aspect, the anti fungin, albaconazole, amorolfin, amphotericin b, anidula fungal agent can be obtained from a bulk source. The 45 fungin, bifonazole, butenafine, butoconazole, candicidin, anti-fungal agent can be pure or Substantially pure. caspofungin, ciclopiroX, clotrimazole, econazole, fenticon In an aspect, the compounded composition can comprise azole, filipin, fluconazole, flucytosine, griseofulvin, halo and excipient base powder. In an aspect, the excipient base progin, hamycin, isavuconazole, isoconazole, itraconazole, powder can comprise LoxasperseTM excipient base powder. ketoconazole, micafungin, miconazole, naftifine, natamycin, In an aspect, the excipient base powder can comprise 50 nystatin, omoconazole, oxiconazole, polygodial, posacon LoxasperseTM excipient base powder and XyliFosTM excipi azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, ent base powder. In an aspect, an excipient base powder can terbinafine, terconazole, tioconazole, tolnaftate, undecylenic be obtained from a bulk source. acid, Voriconazole, or a combination thereof. In an aspect, the anti-bacterial agent can comprise from In an aspect of a disclosed method, the anti-fungal agent about 10% to about 40% w/w of the compounded compo 55 can comprise itraconazole. In an aspect of a disclosed sition. In an aspect, the anti-bacterial agent can comprise method, the anti-fungal agent can comprise fluconazole. In from about 15% to about 35% w/w of the compounded an aspect of a disclosed method, the anti-fungal agent can composition. In an aspect, the anti-bacterial agent can com comprise nystatin. prise from about 20% to about 30% w/w of the compounded In an aspect of a disclosed method, the anti-bacterial agent composition. In an aspect, the anti-bacterial agent can com 60 can comprise mupirocin and the anti-fungal agent can com prise about 25% w/w of the compounded composition. prise itraconazole. In an aspect of a disclosed method, the In an aspect, the anti-fungal agent can comprise from anti-bacterial agent can comprise azithromycin and the about 10% to about 40% w/w of the compounded compo anti-fungal agent can comprise fluconazole. In an aspect of sition. In an aspect, the anti-fungal agent can comprise from a disclosed method, the anti-bacterial agent can comprise about 15% to about 35% w/w of the compounded compo 65 mupirocin and the anti-fungal agent can comprise nystatin. sition. In an aspect, the anti-fungal agent can comprise from In an aspect, a disclosed compounded composition can about 20% to about 30% w/w of the compounded compo comprise one or more additional anti-infective agents. In an US 9,707,229 B2 75 76 aspect, the additional anti-infective agent can be a dry In an aspect, contacting can comprise placing at least part powder. In an aspect, the additional anti-infective agent can of one or both feet of the subject in the foot bath. In an be an ointment. The additional anti-infective agent can be aspect, contacting can comprise placing at least part of one pure or substantially pure. The additional anti-infective or both feet of the subject in the foot bath for about 5 to agent can be obtained from a bulk source. In an aspect, the about 15 minutes. In an aspect, contacting can comprise additional anti-infective agent can be an anti-bacterial agent. placing at least part of one or both feet of the subject in the Anti-bacterial agents are known to the art and discussed foot bath for about 10 minutes. Supra. In an aspect, the additional anti-infective agent can be In an aspect, the method can comprise repeating steps an anti-fungal agent. Anti-fungal agents are known to the art (i)-(iii) daily. In an aspect, the method can comprise repeat and discussed Supra. 10 ing steps (i)-(iii) daily until the bacterial infection or Sus In an aspect, the method can comprise orally administer pected bacterial infection can be eradicated. In an aspect, the ing to the Subject a pharmaceutical composition comprising method can comprise repeating steps (i)-(iii) daily until the an anti-bacterial agent. In an aspect, the method can com fungal infection or Suspected fungal infection can be eradi prise orally administering to the Subject a pharmaceutical cated. In an aspect, the method can comprise repeating steps composition comprising an anti-fungal agent. In an apsect, 15 (i)-(iii) daily until the infection or the suspected infection the method can comprise orally administering to the Subject can be eradicated. a pharmaceutical composition comprising an anti-bacterial In an aspect, the method can comprise heating the water agent and a pharmaceutical composition comprising an contained within the foot bath. anti-fungal agent. In an aspect, a foot bath can comprise a mechanical In an aspect, a disclosed compounded composition com agitation agent to mechanically agitate the enclosed water, a prising an anti-bacterial agent and an anti-fungal agent can heating agent to heat the enclosed water, or both. Mechani be encapsulated in one or more capsules. In an aspect, the cal agitation agents and/or means to agitate water within a one or more capsules comprising the compounded compo compartment are known to the art. In an aspect, a mechani sition can be added to the water contained within the foot cal agitation agent can be a motorized agitation agent. In an bath. In an aspect, the one or more capsules can disintegrate 25 aspect, an agitation agent or an agitator can be coupled to and the compounded composition can be dissolved in the both a motor and the foot bath. Motors and agitators are water contained within the foot bath. In an aspect, a subject known to the art. In an aspect, mechanical agitation can can open or break apart the one or more capsule and pour the serve to distribute the compounded composition throughout contents of the opened or broken capsules into the water the water contained within the foot bath. Heating agents contained within a foot bath. 30 and/or means to heat water in a compartment are known to In an aspect, a disclosed method can comprise emptying the art. the water from the foot bath. In an aspect, a disclosed In an aspect, the compounded composition can comprise method can comprise cleaning the foot bath. In an aspect, a an excipient base powder comprising a blend of micronized disclosed method can comprise drying the foot bath. Xylitol and poloxamers. In an aspect, the excipient base In an aspect, a disclosed method can treat or prevent an 35 powder can comprise LoxasperseTM excipient base powder. infection affecting the skin of at least a portion of a subjects In an aspect, the excipient base powder can comprise foot or feet. In an aspect, a disclosed method can treat or LoxasperseTM excipient base powder and XyliFosTM excipi prevent an infection affecting the nail of at least one toe on ent base powder. In an aspect, an excipient base powder can a subjects foot or feet. be obtained from a bulk source. 2. Compounded Composition Comprising Mupirocin and/or 40 In an aspect, the compounded composition can be a dry Itraconazole powder formulation. Disclosed herein is a method of treating or preventing an In an aspect, the mupirocin can be a dry powder. In an infection, the method comprising: (i) adding a compounded aspect, the mupirocin can be an ointment. The anti-bacterial composition comprising mupirocin and itraconazole to agent can be pure or Substantially pure. In an aspect, the water contained within a foot bath; (ii) agitating the water 45 mupirocin can be obtained from a bulk source. In an aspect, contained within the foot bath; and (iii) contacting the the itraconazole can be a dry powder. In an aspect, the agitated water with at least a part of one or both feet of a itraconazole can be an ointment. The itraconazole can be Subject. pure or Substantially pure. In an aspect, the itraconazole can In an aspect, the method can comprise adding a diluent to be obtained from a bulk source. the water contained in the foot bath. In an aspect, the diluent 50 In an aspect, the mupirocin can comprise from about 10% can comprise Sodium hypochlorite. In an aspect, the diluent to about 40% w/w of the compounded composition. In an can comprise Dakin's Solution. In an aspect, the amount of aspect, the mupirocin can comprise from about 15% to about diluent can be about 3.75 mL to about 60 mL. In an aspect, 35% w/w of the compounded composition. In an aspect, the the amount of diluent can be about 15 mL. mupirocin can comprise from about 20% to about 30% w/w In an aspect, the Subject has been diagnosed with or is 55 of the compounded composition. In an aspect, the mupirocin Suspected of having a bacterial infection that affects at least can comprise about 25% w/w of the compounded compo part of one or both feet. In an aspect, the subject has been sition. diagnosed with or is Suspected of having a fungal infection In an aspect, the itraconazole can comprise from about that affects at least part of one or both feet. In an aspect, the 10% to about 40% w/w of the compounded composition. In Subject has been diagnosed with or is Suspected of having a 60 an aspect, the itraconazole can comprise from about 15% to bacterial infection and a fungal infection that affect at least about 35% w/w of the compounded composition. In an part of one or both feet. aspect, the itraconazole can comprise from about 20% to In an aspect, the Subject can have diabetes. In an aspect, about 30% w/w of the compounded composition. In an the Subject can be obese. In an aspect, the Subject can have aspect, the itraconazole can comprise about 25% w/w of the poor blood flow. In an aspect, the Subject can routinely wear 65 compounded composition. thick Socks. In an aspect, the Subject can routinely wear In an aspect, the ratio of the mupirocin to the itraconazole heavy boots. in the compounded composition can be from about 1:4 to US 9,707,229 B2 77 78 about 4:1. In an aspect, the ratio of the mupirocin to the In an aspect, the Subject has been diagnosed with or is itraconazole can be about 1:1. In an aspect, the ratio of the Suspected of having a bacterial infection that affects at least mupirocinto the itraconazole can be about 1.25:1. See, e.g., part of one or both feet. In an aspect, the subject has been Table 1. diagnosed with or is Suspected of having a fungal infection In an aspect, a disclosed compounded composition can that affects at least part of one or both feet. In an aspect, the comprise one or more additional anti-infective agents. In an Subject has been diagnosed with or is suspected of having a aspect, the additional anti-infective agent can be a dry bacterial infection and a fungal infection that affect at least powder. In an aspect, the additional anti-infective agent can part of one or both feet. be an ointment. The additional anti-infective agent can be In an aspect, the Subject can have diabetes. In an aspect, pure or substantially pure. The additional anti-infective 10 the Subject can be obese. In an aspect, the Subject can have agent can be obtained from a bulk source. In an aspect, the poor blood flow. In an aspect, the Subject can routinely wear additional anti-infective agent can be an anti-bacterial agent. thick Socks. In an aspect, the Subject can routinely wear Anti-bacterial agents are known to the art and discussed heavy boots. Supra. In an aspect, the additional anti-infective agent can be In an aspect, contacting can comprise placing at least part an anti-fungal agent. Anti-fungal agents are known to the art 15 of one or both feet of the subject in the foot bath. In an and discussed Supra. aspect, contacting can comprise placing at least part of one In an aspect, the method can comprise orally administer or both feet of the subject in the foot bath for about 5 to ing to the Subject a pharmaceutical composition comprising about 15 minutes. In an aspect, contacting can comprise an anti-bacterial agent. Anti-bacterial agents are known to placing at least part of one or both feet of the subject in the the art and discussed Supra. In an aspect, the method can foot bath for about 10 minutes. comprise orally administering to the Subject a pharmaceu In an aspect, the method can comprise repeating steps tical composition comprising an anti-fungal agent. Anti (i)-(iv) daily. In an aspect, the method can comprise repeat fungal agents are known to the art and discussed Supra. In an ing steps (i)-(iv) daily until the bacterial infection or Sus apsect, the method can comprise orally administering to the pected bacterial infection can be eradicated. In an aspect, the Subject a pharmaceutical composition comprising an anti 25 method can comprise repeating steps (i)-(iv) daily until the bacterial agent and a pharmaceutical composition compris fungal infection or Suspected fungal infection can be eradi ing an anti-fungal agent. cated. In an aspect, the method can comprise repeating steps In an aspect, a disclosed compounded composition com (i)-(iv) daily until the infection or the suspected infection prising mupirocin and itraconazole can be encapsulated in can be eradicated. one or more capsules. In an aspect, the one or more capsules 30 In an aspect, the method can comprise heating the water comprising the compounded composition can be added to contained within the foot bath. the water contained within the foot bath. In an aspect, the In an aspect, a foot bath can comprise a mechanical one or more capsules can disintegrate and the compounded agitation agent to mechanically agitate the enclosed water, a composition can be dissolved in the water contained within heating agent to heat the enclosed water, or both. Mechani the foot bath. In an aspect, a Subject can open or break apart 35 cal agitation agents and/or means to agitate water within a the one or more capsule and pour the contents of the opened compartment are known to the art. In an aspect, a mechani or broken capsules into the water contained within a foot cal agitation agent can be a motorized agitation agent. In an bath. aspect, an agitation agent or an agitator can be coupled to In an aspect, a disclosed method can comprise emptying both a motor and the foot bath. Motors and agitators are the water from the foot bath. In an aspect, a disclosed 40 known to the art. In an aspect, mechanical agitation can method can comprise cleaning the foot bath. In an aspect, a serve to distribute the solution throughout the water con disclosed method can comprise drying the foot bath. tained within the foot bath. Heating agents and/or means to In an aspect, a disclosed method can treat or prevent an heat water in a compartment are known to the art. infection affecting the skin of at least a portion of a subjects In an aspect, the compounded composition can comprise foot or feet. In an aspect, a disclosed method can treat or 45 an excipient base powder comprising a blend of micronized prevent an infection affecting the nail of at least one toe on Xylitol and poloxamers. In an aspect, the compounded a subjects foot or feet. composition can be a dry powder formulation. In an aspect, Disclosed herein is a method of treating or preventing an the mupirocin can be obtained from a bulk source. The infection, the method comprising: (i) mixing a compounded mupirocin can be pure or Substantially pure. In an aspect, the composition comprising mupirocin and itraconazole with a 50 itraconazole can be obtained from a bulk source. The diluent to create a solution; (ii) adding the solution to water itraconazole can be pure or Substantially pure. contained within a foot bath; (iii) agitating the water con In an aspect, the excipient base powder can comprise tained within the foot bath; and (iv) contacting the agitated LoxasperseTM excipient base powder. In an aspect, the water with at least part of one or both feet of a subject. excipient base powder can comprise Loxasperse M excipient In an aspect, the diluent can comprise sodium hypochlo 55 base powder and XyliFosTM excipient base powder. In an rite. In an aspect, the diluent can comprise Dakin's solution. aspect, an excipient base powder can be obtained from a In an aspect, the amount of diluent can be about 3.75 mL to bulk source. about 60 mL. In an aspect, the amount of diluent can be In an aspect, the mupirocin can comprise from about 10% about 15 mL. to about 40% w/w of the compounded composition. In an In an aspect, the compounded composition and the diluent 60 aspect, the mupirocin can comprise from about 15% to about can be mixed in a mixing container. In an aspect, a mixing 35% w/w of the compounded composition. In an aspect, the container can have a pre-determined size that can measure or mupirocin can comprise from about 20% to about 30% w/w hold a pre-determined amount or Volume. For example, in an of the compounded composition. In an aspect, the mupirocin aspect, a mixing container can measure or hold an amount can comprise about 25% w/w of the compounded compo of about 1 ounces to about 30 ounces. In an aspect, the 65 sition. mixing container can hold about 6 ounces. In an aspect, the In an aspect, the itraconazole can comprise from about mixing container can hold about 16 ounces. 10% to about 40% w/w of the compounded composition. In US 9,707,229 B2 79 80 an aspect, the itraconazole can comprise from about 15% to diluent can be about 3.75 mL to about 60 mL. In an aspect, about 35% w/w of the compounded composition. In an the amount of diluent can be about 15 mL. aspect, the itraconazole can comprise from about 20% to In an aspect, the Subject has been diagnosed with or is about 30% w/w of the compounded composition. In an Suspected of having a bacterial infection that affects at least aspect, the itraconazole can comprise about 25% w/w of the part of one or both feet. In an aspect, the subject has been compounded composition. diagnosed with or is Suspected of having a fungal infection In an aspect, the ratio of the mupirocin to the itraconazole that affects at least part of one or both feet. In an aspect, the in the compounded composition can be from about 1:4 to Subject has been diagnosed with or is suspected of having a about 4:1. In an aspect, the ratio of the mupirocin to the bacterial infection and a fungal infection that affect at least 10 part of one or both feet. itraconazole can be about 1:1. See, e.g., Table 1. In an aspect, the Subject can have diabetes. In an aspect, In an aspect, a disclosed compounded composition can the Subject can be obese. In an aspect, the Subject can have comprise one or more additional anti-infective agents. In an poor blood flow. In an aspect, the Subject can routinely wear aspect, the additional anti-infective agent can be a dry thick Socks. In an aspect, the Subject can routinely wear powder. In an aspect, the additional anti-infective agent can 15 heavy boots. be an ointment. The additional anti-infective agent can be In an aspect, contacting can comprise placing at least part pure or substantially pure. The additional anti-infective of one or both feet of the subject in the foot bath. In an agent can be obtained from a bulk source. aspect, contacting can comprise placing at least part of one In an aspect, the additional anti-infective agent can be an or both feet of the subject in the foot bath for about 5 to anti-bacterial agent. Anti-bacterial agents are known to the about 15 minutes. In an aspect, contacting can comprise art and discussed Supra. In an aspect, the additional anti placing at least part of one or both feet of the subject in the infective agent can be an anti-fungal agent. Anti-fungal foot bath for about 10 minutes. agents are known to the art and discussed Supra. In an aspect, the method can comprise repeating steps In an aspect, the method can comprise orally administer (i)-(iii) daily. In an aspect, the method can comprise repeat ing to the Subject a pharmaceutical composition comprising 25 ing steps (i)-(iii) daily until the bacterial infection or Sus an anti-bacterial agent. Anti-bacterial agents are known to pected bacterial infection can be eradicated. In an aspect, the the art and discussed Supra. In an aspect, the method can method can comprise repeating steps (i)-(iii) daily until the comprise orally administering to the Subject a pharmaceu fungal infection or Suspected fungal infection can be eradi tical composition comprising an anti-fungal agent. Anti cated. In an aspect, the method can comprise repeating steps fungal agents are known to the art and discussed Supra. In an 30 (i)-(iii) daily until the infection or the suspected infection apsect, the method can comprise orally administering to the can be eradicated. Subject a pharmaceutical composition comprising an anti In an aspect, the method can comprise heating the water bacterial agent and a pharmaceutical composition compris contained within the foot bath. ing an anti-fungal agent. In an aspect, a foot bath can comprise a mechanical In an aspect, a disclosed compounded composition com 35 agitation agent to mechanically agitate the enclosed water, a prising mupirocin and itraconazole can be encapsulated in heating agent to heat the enclosed water, or both. Mechani one or more capsules. In an aspect, the one or more capsules cal agitation agents and/or means to agitate water within a comprising the compounded composition can be added to compartment are known to the art. In an aspect, a mechani the water contained within the foot bath. In an aspect, the cal agitation agent can be a motorized agitation agent. In an one or more capsules can disintegrate and the compounded 40 aspect, an agitation agent or an agitator can be coupled to composition can be dissolved in the water contained within both a motor and the foot bath. Motors and agitators are the foot bath. In an aspect, a Subject can open or break apart known to the art. In an aspect, mechanical agitation can the one or more capsule and pour the contents of the opened serve to distribute the compounded composition throughout or broken capsules into the water contained within a foot the water contained within the foot bath. Heating agents bath. 45 and/or means to heat water in a compartment are known to In an aspect, a disclosed method can comprise emptying the art. the water from the foot bath. In an aspect, a disclosed In an aspect, the compounded composition can comprise method can comprise cleaning the foot bath. In an aspect, a an excipient base powder comprising a blend of micronized disclosed method can comprise drying the foot bath. Xylitol and poloxamers. In an aspect, the excipient base In an aspect, a disclosed method can treat or prevent an 50 powder can comprise LoxasperseTM excipient base powder. infection affecting the skin of at least a portion of a subjects In an aspect, the excipient base powder can comprise foot or feet. In an aspect, a disclosed method can treat or LoxasperseTM excipient base powder and XyliFosTM excipi prevent an infection affecting the nail of at least one toe on ent base powder. In an aspect, an excipient base powder can a subjects foot or feet. be obtained from a bulk source. 3. Compounded Composition Comprising Azithromycin 55 In an aspect, the compounded composition can be a dry and/or Fluconazole powder formulation. In an aspect, the azithromycin can be Disclosed herein is a method of treating or preventing an obtained from a bulk source. The azithromycin can be pure infection, the method comprising: (i) adding a compounded or Substantially pure. In an aspect, the fluconazole can be composition comprising azithromycin and fluconazole to obtained from a bulk source. The fluconazole can be pure or water contained within a foot bath; (ii) agitating the water 60 Substantially pure. contained within the foot bath; and (iii) contacting the In an aspect, the azithromycin can comprise from about agitated water with at least a part of one or both feet of a 10% to about 60% w/w of the compounded composition. In Subject. an aspect, the azithromycin can comprise from about 20% to In an aspect, the method can comprise adding a diluent to about 50% w/w of the compounded composition. In an the water contained in the foot bath. In an aspect, the diluent 65 aspect, the azithromycin can comprise from about 30% to can comprise Sodium hypochlorite. In an aspect, the diluent about 40% w/w of the compounded composition. In an can comprise Dakin's Solution. In an aspect, the amount of aspect, the azithromycin can comprise about 25% w/w of the US 9,707,229 B2 81 82 compounded composition. In an aspect, the azithromycin tained within the foot bath; and (iv) contacting the agitated can comprise about 50% w/w of the compounded compo water with at least part of one or both feet of a subject. sition. In an aspect, the diluent can comprise Sodium hypochlo In an aspect, the fluconazole can comprise from about rite. In an aspect, the diluent can comprise Dakin's solution. 10% to about 60% w/w of the compounded composition. In In an aspect, the amount of diluent can be about 3.75 mL to an aspect, the fluconazole can comprise from about 20% to about 60 mL. In an aspect, the amount of diluent can be about 50% w/w of the compounded composition. In an about 15 mL. aspect, the fluconazole can comprise from about 30% to In an aspect, the compounded composition and the diluent about 40% w/w of the compounded composition. In an can be mixed in a mixing container. In an aspect, a mixing aspect, the fluconazole can comprise about 25% w/w of the 10 container can have a pre-determined size that can measure or compounded composition. In an aspect, the fluconazole can hold a pre-determined amount or Volume. For example, in an comprise about 50% w/w of the compounded composition. aspect, a mixing container can measure or hold an amount In an aspect, the ratio of the azithromycin to the flucon of about 1 ounces to about 30 ounces. In an aspect, the azole in the compounded composition can be from about 1:4 15 mixing container can hold about 6 ounces. In an aspect, the to about 4:1. In an aspect, the ratio of azithromycin to the mixing container can hold about 16 ounces. fluconazole can be about 1:1. In an aspect, the ratio of the In an aspect, the Subject has been diagnosed with or is azithromycin to the fluconazole be about 1.25:1. See, e.g., Suspected of having a bacterial infection that affects at least Table 3. part of one or both feet. In an aspect, the subject has been In an aspect, a disclosed compounded composition can diagnosed with or is Suspected of having a fungal infection comprise one or more additional anti-infective agents. In an that affects at least part of one or both feet. In an aspect, the aspect, the additional anti-infective agent can be a dry Subject has been diagnosed with or is suspected of having a powder. In an aspect, the additional anti-infective agent can bacterial infection and a fungal infection that affect at least be an ointment. The additional anti-infective agent can be part of one or both feet. pure or substantially pure. The additional anti-infective 25 In an aspect, the Subject can have diabetes. In an aspect, agent can be obtained from a bulk source. In an aspect, the the Subject can be obese. In an aspect, the Subject can have additional anti-infective agent can be an anti-bacterial agent. poor blood flow. In an aspect, the Subject can routinely wear Anti-bacterial agents are known to the art and discussed thick Socks. In an aspect, the Subject can routinely wear Supra. In an aspect, the additional anti-infective agent can be heavy boots. an anti-fungal agent. Anti-fungal agents are known to the art 30 In an aspect, contacting can comprise placing at least part and discussed Supra. of one or both feet of the subject in the foot bath. In an In an aspect, the method can comprise orally administer aspect, contacting can comprise placing at least part of one ing to the Subject a pharmaceutical composition comprising or both feet of the subject in the foot bath for about 5 to an anti-bacterial agent. Anti-bacterial agents are known to about 15 minutes. In an aspect, contacting can comprise the art and discussed Supra. In an aspect, the method can 35 placing at least part of one or both feet of the subject in the comprise orally administering to the Subject a pharmaceu foot bath for about 10 minutes. tical composition comprising an anti-fungal agent. Anti In an aspect, the method can comprise repeating steps fungal agents are known to the art and discussed Supra. In an (i)-(iv) daily. In an aspect, the method can comprise repeat apsect, the method can comprise orally administering to the ing steps (i)-(iv) daily until the bacterial infection or Sus Subject a pharmaceutical composition comprising an anti 40 pected bacterial infection can be eradicated. In an aspect, the bacterial agent and a pharmaceutical composition compris method can comprise repeating steps (i)-(iv) daily until the ing an anti-fungal agent. fungal infection or Suspected fungal infection can be eradi In an aspect, a disclosed compounded composition com cated. In an aspect, the method can comprise repeating steps prising azithromycin and fluconazole can be encapsulated in (i)-(iv) daily until the infection or the suspected infection one or more capsules. In an aspect, the one or more capsules 45 can be eradicated. comprising the compounded composition can be added to In an aspect, the method can comprise heating the water the water contained within the foot bath. In an aspect, the contained within the foot bath. one or more capsules can disintegrate and the compounded In an aspect, a foot bath can comprise a mechanical composition can be dissolved in the water contained within agitation agent to mechanically agitate the enclosed water, a the foot bath. In an aspect, a Subject can open or break apart 50 heating agent to heat the enclosed water, or both. Mechani the one or more capsule and pour the contents of the opened cal agitation agents and/or means to agitate water within a or broken capsules into the water contained within a foot compartment are known to the art. In an aspect, a mechani bath. cal agitation agent can be a motorized agitation agent. In an In an aspect, a disclosed method can comprise emptying aspect, an agitation agent or an agitator can be coupled to the water from the foot bath. In an aspect, a disclosed 55 both a motor and the foot bath. Motors and agitators are method can comprise cleaning the foot bath. In an aspect, a known to the art. In an aspect, mechanical agitation can disclosed method can comprise drying the foot bath. serve to distribute the solution throughout the water con In an aspect, a disclosed method can treat or prevent an tained within the foot bath. Heating agents and/or means to infection affecting the skin of at least a portion of a subjects heat water in a compartment are known to the art. foot or feet. In an aspect, a disclosed method can treat or 60 In an aspect, the compounded composition can comprise prevent an infection affecting the nail of at least one toe on an excipient base powder comprising a blend of micronized a subjects foot or feet. Xylitol and poloxamers. In an aspect, the compounded Disclosed herein is a method of treating or preventing an composition can be a dry powder formulation. In an aspect, infection, the method comprising: (i) mixing a compounded the azithromycin can be obtained from a bulk source. The composition comprising azithromycin and fluconazole with 65 azithromycin can be pure or Substantially pure. In an aspect, a diluent to create a solution; (ii) adding the Solution to water the fluconazole can be obtained from a bulk source. The contained within a foot bath; (iii) agitating the water con fluconazole can be pure or Substantially pure. US 9,707,229 B2 83 84 In an aspect, the excipient base powder can comprise method can comprise cleaning the foot bath. In an aspect, a LoxasperseTM excipient base powder. In an aspect, the disclosed method can comprise drying the foot bath. excipient base powder can comprise Loxasperse M excipient In an aspect, a disclosed method can treat or prevent an base powder and XyliFosTM excipient base powder. In an infection affecting the skin of at least a portion of a subjects aspect, an excipient base powder can be obtained from a foot or feet. In an aspect, a disclosed method can treat or bulk source. prevent an infection affecting the nail of at least one toe on In an aspect, the azithromycin can comprise from about a subjects foot or feet. 10% to about 60% w/w of the compounded composition. In 4. Compounded Composition Comprising Mupirocin and/or an aspect, the azithromycin can comprise from about 20% to Nystatin about 50% w/w of the compounded composition. In an 10 Disclosed herein is a method of treating or preventing an aspect, the azithromycin can comprise from about 30% to infection, the method comprising: (i) adding a compounded about 40% w/w of the compounded composition. In an composition comprising mupirocin and nyStatin to water aspect, the azithromycin can comprise about 25% w/w of the contained within a foot bath; (ii) agitating the water con compounded composition. In an aspect, the azithromycin tained within the foot bath; and (iii) contacting the agitated can comprise about 50% w/w of the compounded compo 15 water with at least a part of one or both feet of a subject. sition. In an aspect, the method can comprise adding a diluent to In an aspect, the fluconazole can comprise from about the water contained in the foot bath. In an aspect, the diluent 10% to about 60% w/w of the compounded composition. In can comprise sodium hypochlorite. In an aspect, the diluent an aspect, the fluconazole can comprise from about 20% to can comprise Dakin's Solution. In an aspect, the amount of about 50% w/w of the compounded composition. In an diluent can be about 3.75 mL to about 60 mL. In an aspect, aspect, the fluconazole can comprise from about 30% to the amount of diluent can be about 15 mL. about 40% w/w of the compounded composition. In an In an aspect, the Subject has been diagnosed with or is aspect, the fluconazole can comprise about 25% w/w of the Suspected of having a bacterial infection that affects at least compounded composition. In an aspect, the fluconazole can part of one or both feet. In an aspect, the subject has been comprise about 50% w/w of the compounded composition. 25 diagnosed with or is Suspected of having a fungal infection In an aspect, the ratio of the azithromycin to the flucon that affects at least part of one or both feet. In an aspect, the azole in the compounded composition can be from about 1:4 Subject has been diagnosed with or is suspected of having a to about 4:1. In an aspect, the ratio of the azithromycinto the bacterial infection and a fungal infection that affect at least fluconazole can be about 1:1. In an aspect, the ratio of the part of one or both feet. azithromycin to the fluconazole can be about 1.25:1. See, 30 In an aspect, the Subject can have diabetes. In an aspect, e.g., Table 1. the Subject can be obese. In an aspect, the Subject can have In an aspect, a disclosed compounded composition can poor blood flow. In an aspect, the subject can routinely wear comprise one or more additional anti-infective agents. In an thick Socks. In an aspect, the Subject can routinely wear aspect, the additional anti-infective agent can be a dry heavy boots. powder. In an aspect, the additional anti-infective agent can 35 In an aspect, contacting can comprise placing at least part be an ointment. The additional anti-infective agent can be of one or both feet of the subject in the foot bath. In an pure or substantially pure. The additional anti-infective aspect, contacting can comprise placing at least part of one agent can be obtained from a bulk source. In an aspect, the or both feet of the subject in the foot bath for about 5 to additional anti-infective agent can be an anti-bacterial agent. about 15 minutes. In an aspect, contacting can comprise Anti-bacterial agents are known to the art and discussed 40 placing at least part of one or both feet of the subject in the Supra. In an aspect, the additional anti-infective agent can be foot bath for about 10 minutes. an anti-fungal agent. Anti-fungal agents are known to the art In an aspect, the method can comprise repeating steps and discussed Supra. (i)-(iii) daily. In an aspect, the method can comprise repeat In an aspect, the method can comprise orally administer ing steps (i)-(iii) daily until the bacterial infection or Sus ing to the Subject a pharmaceutical composition comprising 45 pected bacterial infection can be eradicated. In an aspect, the an anti-bacterial agent. Anti-bacterial agents are known to method can comprise repeating steps (i)-(iii) daily until the the art and discussed Supra. In an aspect, the method can fungal infection or Suspected fungal infection can be eradi comprise orally administering to the Subject a pharmaceu cated. In an aspect, the method can comprise repeating steps tical composition comprising an anti-fungal agent. Anti (i)-(iii) daily until the infection or the suspected infection fungal agents are known to the art and discussed Supra. In an 50 can be eradicated. aspect, the method can comprise orally administering to the In an aspect, the method can comprise heating the water Subject a pharmaceutical composition comprising an anti contained within the foot bath. bacterial agent and a pharmaceutical composition compris In an aspect, a foot bath can comprise a mechanical ing an anti-fungal agent. agitation agent to mechanically agitate the enclosed water, a In an aspect, a disclosed compounded composition com 55 heating agent to heat the enclosed water, or both. Mechani prising azithromycin and fluconazole can be encapsulated in cal agitation agents and/or means to agitate water within a one or more capsules. In an aspect, the one or more capsules compartment are known to the art. In an aspect, a mechani comprising the compounded composition can be added to cal agitation agent can be a motorized agitation agent. In an the water contained within the foot bath. In an aspect, the aspect, an agitation agent or an agitator can be coupled to one or more capsules can disintegrate and the compounded 60 both a motor and the foot bath. Motors and agitators are composition can be dissolved in the water contained within known to the art. In an aspect, mechanical agitation can the foot bath. In an aspect, a Subject can open or break apart serve to distribute the compounded composition throughout the one or more capsule and pour the contents of the opened the water contained within the foot bath. Heating agents or broken capsules into the water contained within a foot and/or means to heat water in a compartment are known to bath. 65 the art. In an aspect, a disclosed method can comprise emptying In an aspect, the compounded composition can comprise the water from the foot bath. In an aspect, a disclosed an excipient base powder comprising a blend of micronized US 9,707,229 B2 85 86 Xylitol and poloxamers. In an aspect, the excipient base the one or more capsule and pour the contents of the opened powder can comprise LoxasperseTM excipient base powder. or broken capsules into the water contained within a foot In an aspect, the excipient base powder can comprise bath. LoxasperseTM excipient base powder and XyliFosTM excipi In an aspect, a disclosed method can comprise emptying ent base powder. In an aspect, an excipient base powder can the water from the foot bath. In an aspect, a disclosed be obtained from a bulk source. method can comprise cleaning the foot bath. In an aspect, a In an aspect, the compounded composition can be a dry disclosed method can comprise drying the foot bath. powder formulation. In an aspect, a disclosed method can treat or prevent an In an aspect, the mupirocin can be a dry powder. In an infection affecting the skin of at least a portion of a subjects aspect, the mupirocin can be an ointment. In an aspect, the 10 foot or feet. In an aspect, a disclosed method can treat or mupirocin can be a 2% ointment. The mupirocin can be pure prevent an infection affecting the nail of at least one toe on or substantially pure. The mupirocin can be obtained from a a subjects foot or feet. bulk source. In an aspect, the nyStatin can be a dry powder. Disclosed herein is a method of treating or preventing an In an aspect, the nystatin can be an ointment. The nyStatin infection, the method comprising: (i) mixing a compounded can be pure or Substantially pure. The nystatin can be 15 composition comprising mupirocin and nystatin with a obtained from a bulk source. diluent to create a solution; (ii) adding the solution to water In an aspect, the mupirocin can comprise from about 10% contained within a foot bath; (iii) agitating the water con to about 40% w/w of the compounded composition. In an tained within the foot bath; and (iv) contacting the agitated aspect, the mupirocin can comprise from about 15% to about water with at least part of one or both feet of a subject. 35% w/w of the compounded composition. In an aspect, the In an aspect, the diluent can comprise Sodium hypochlo mupirocin can comprise from about 20% to about 30% w/w rite. In an aspect, the diluent can comprise Dakin's solution. of the compounded composition. In an aspect, the mupirocin In an aspect, the amount of diluent can be about 3.75 mL to can comprise about 25% w/w of the compounded compo about 60 mL. In an aspect, the amount of diluent can be sition. about 15 mL. In an aspect, the nystatin can comprise from about 10% to 25 In an aspect, the compounded composition and the diluent about 40% w/w of the compounded composition. In an can be mixed in a mixing container. In an aspect, a mixing aspect, the nyStatin can comprise from about 15% to about container can have a pre-determined size that can measure or 35% w/w of the compounded composition. In an aspect, the hold a pre-determined amount or Volume. For example, in an nystatin can comprise from about 20% to about 30% w/w of aspect, a mixing container can measure or hold an amount the compounded composition. In an aspect, the nyStatin can 30 of about 1 ounces to about 30 ounces. In an aspect, the comprise about 25% w/w of the compounded composition. mixing container can hold about 6 ounces. In an aspect, the In an aspect, the ratio of the mupirocin to the nystatin in mixing container can hold about 16 ounces. the compounded composition can be from about 1:4 to about In an aspect, the Subject has been diagnosed with or is 4:1. In an aspect, the ratio of the mupirocin to the nystatin Suspected of having a bacterial infection that affects at least can be about 1:1. In an aspect, the ratio of the mupirocin to 35 part of one or both feet. In an aspect, the subject has been the nystatin can be about 1.25:1. See, e.g., Table 3. diagnosed with or is Suspected of having a fungal infection In an aspect, a disclosed compounded composition can that affects at least part of one or both feet. In an aspect, the comprise one or more additional anti-infective agents. In an Subject has been diagnosed with or is suspected of having a aspect, the additional anti-infective agent can be a dry bacterial infection and a fungal infection that affect at least powder. In an aspect, the additional anti-infective agent can 40 part of one or both feet. be an ointment. The additional anti-infective agent can be In an aspect, the Subject can have diabetes. In an aspect, pure or substantially pure. The additional anti-infective the Subject can be obese. In an aspect, the Subject can have agent can be obtained from a bulk source. In an aspect, the poor blood flow. In an aspect, the Subject can routinely wear additional anti-infective agent can be an anti-bacterial agent. thick Socks. In an aspect, the Subject can routinely wear Anti-bacterial agents are known to the art and discussed 45 heavy boots. Supra. In an aspect, the additional anti-infective agent can be In an aspect, contacting can comprise placing at least part an anti-fungal agent. Anti-fungal agents are known to the art of one or both feet of the subject in the foot bath. In an and discussed Supra. aspect, contacting can comprise placing at least part of one In an aspect, the method can comprise orally administer or both feet of the subject in the foot bath for about 5 to ing to the Subject a pharmaceutical composition comprising 50 about 15 minutes. In an aspect, contacting can comprise an anti-bacterial agent. Anti-bacterial agents are known to placing at least part of one or both feet of the subject in the the art and discussed Supra. In an aspect, the method can foot bath for about 10 minutes. comprise orally administering to the Subject a pharmaceu In an aspect, the method can comprise repeating steps tical composition comprising an anti-fungal agent. Anti (i)-(iv) daily. In an aspect, the method can comprise repeat fungal agents are known to the art and discussed Supra. In an 55 ing steps (i)-(iv) daily until the bacterial infection or Sus aspect, the method can comprise orally administering to the pected bacterial infection can be eradicated. In an aspect, the Subject a pharmaceutical composition comprising an anti method can comprise repeating steps (i)-(iv) daily until the bacterial agent and a pharmaceutical composition compris fungal infection or Suspected fungal infection can be eradi ing an anti-fungal agent. cated. In an aspect, the method can comprise repeating steps In an aspect, a disclosed compounded composition com 60 (i)-(iv) daily until the infection or the suspected infection prising mupirocin and nystatin can be encapsulated in one or can be eradicated. more capsules. In an aspect, the one or more capsules In an aspect, the method can comprise heating the water comprising the compounded composition can be added to contained within the foot bath. the water contained within the foot bath. In an aspect, the In an aspect, a foot bath can comprise a mechanical one or more capsules can disintegrate and the compounded 65 agitation agent to mechanically agitate the enclosed water, a composition can be dissolved in the water contained within heating agent to heat the enclosed water, or both. Mechani the foot bath. In an aspect, a Subject can open or break apart cal agitation agents and/or means to agitate water within a US 9,707,229 B2 87 88 compartment are known to the art. In an aspect, a mechani Subject a pharmaceutical composition comprising an anti cal agitation agent can be a motorized agitation agent. In an bacterial agent and a pharmaceutical composition compris aspect, an agitation agent or an agitator can be coupled to ing an anti-fungal agent. both a motor and the foot bath. Motors and agitators are In an aspect, a disclosed compounded composition com known to the art. In an aspect, mechanical agitation can 5 prising mupirocin and nystatin can be encapsulated in one or serve to distribute the solution throughout the water con more capsules. In an aspect, the one or more capsules tained within the foot bath. Heating agents and/or means to comprising the compounded composition can be added to heat water in a compartment are known to the art. the water contained within the foot bath. In an aspect, the In an aspect, the compounded composition can comprise one or more capsules can disintegrate and the compounded an excipient base powder comprising a blend of micronized 10 composition can be dissolved in the water contained within Xylitol and poloxamers. the foot bath. In an aspect, a subject can open or break apart In an aspect, the compounded composition can be a dry the one or more capsule and pour the contents of the opened powder formulation. or broken capsules into the water contained within a foot In an aspect, the mupirocin can be a dry powder. In an bath. aspect, the mupirocin can be an ointment. In an aspect, the 15 In an aspect, a disclosed method can comprise emptying mupirocin can be a 2% ointment. The mupirocin can be pure the water from the foot bath. In an aspect, a disclosed or substantially pure. The mupirocin can be obtained from a method can comprise cleaning the foot bath. In an aspect, a bulk source. In an aspect, the nyStatin can be a dry powder. disclosed method can comprise drying the foot bath. In an aspect, the nystatin can be an ointment. The nyStatin In an aspect, a disclosed method can treat or prevent an can be pure or Substantially pure. The nystatin can be infection affecting the skin of at least a portion of a subjects obtained from a bulk source. foot or feet. In an aspect, a disclosed method can treat or In an aspect, the excipient base powder can comprise prevent an infection affecting the nail of at least one toe on LoxasperseTM excipient base powder. In an aspect, the a subjects foot or feet. excipient base powder can comprise Loxasperse M excipient C. Methods of Treating of Preventing an Infection Using base powder and XyliFosTM excipient base powder. In an 25 Anti-Infective Agents aspect, an excipient base powder can be obtained from a Disclosed herein is a method of treating or preventing an bulk source. infection, the method comprising: (i) adding one or more In an aspect, the mupirocin can comprise from about 10% powders to water contained within a foot bath; (ii) agitating to about 40% w/w of the compounded composition. In an the water contained within the foot bath; and (iii) contacting aspect, the mupirocin can comprise from about 15% to about 30 the agitated water with at least a part of one or both feet of 35% w/w of the compounded composition. In an aspect, the a Subject. mupirocin can comprise from about 20% to about 30% w/w 1. Anti-Bacterial Agent and/or Anti-Fungal Agent of the compounded composition. In an aspect, the mupirocin Disclosed herein is a method of treating or preventing an can comprise about 25% w/w of the compounded compo infection, the method comprising: (i) adding an anti-bacte sition. 35 rial agent to water contained within a foot bath; (ii) adding In an aspect, the nystatin can comprise from about 10% to an anti-fungal agent to the water, (iii) agitating the water about 40% w/w of the compounded composition. In an contained within the foot bath; and (iv) contacting the aspect, the nyStatin can comprise from about 15% to about agitated water with at least a part of one or both feet of a 35% w/w of the compounded composition. In an aspect, the Subject. nystatin can comprise from about 20% to about 30% w/w of 40 In an aspect, the anti-bacterial agent be a dry powder. In the compounded composition. In an aspect, the nyStatin can an aspect, the anti-bacterial agent can be an ointment. In an comprise about 25% w/w of the compounded composition. aspect, the anti-bacterial agent can be obtained from a bulk In an aspect, the ratio of the mupirocin to the nystatin in Source. The anti-bacterial agent can be pure or Substantially the compounded composition can be from about 1:4 to about pure. 4:1. In an aspect, the ratio of the mupirocin to the nystatin 45 In an aspect, the anti-fungal agent be a dry powder. In an can be about 1:1. In an aspect, the ratio of the mupirocin to aspect, the anti-fungal agent can be an ointment. In an the nystatin can be about 1.25:1. See, e.g., Table 3. aspect, the anti-fungal agent can be obtained from a bulk In an aspect, a disclosed compounded composition can Source. The anti-fungal agent can be pure or Substantially comprise one or more additional anti-infective agents. In an pure. aspect, the additional anti-infective agent can be a dry 50 In an aspect, the anti-bacterial agent can comprise powder. In an aspect, the additional anti-infective agent can afenide, amikacin, amoxicillin, amplicillin, arsphenamine, be an ointment. The additional anti-infective agent can be azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra pure or substantially pure. The additional anti-infective cin, carbacephem (loracarbef), carbenicillin, cefaclor, agent can be obtained from a bulk source. In an aspect, the cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi additional anti-infective agent can be an anti-bacterial agent. 55 toren, cefepime, cefixime, cefoperaZone, cefotaxime, Anti-bacterial agents are known to the art and discussed cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, Supra. In an aspect, the additional anti-infective agent can be ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha an anti-fungal agent. Anti-fungal agents are known to the art lexin, chloramphenicol, chlorhexidine, ciprofloxacin, and discussed Supra. clarithromycin, clavulanic acid, clindamycin, cloxacillin, In an aspect, the method can comprise orally administer 60 colimycin, colistimethate teicoplanin, colistin, demeclocy ing to the Subject a pharmaceutical composition comprising cline, dicloxacillin, dirithromycin, doripenem, doxycycline, an anti-bacterial agent. Anti-bacterial agents are known to efprozil, enoxacin, ertapenem, erythromycin, ethambutol, the art and discussed Supra. In an aspect, the method can flucloxacillin, fosfomycin, furazolidone, gatifloxacin, comprise orally administering to the Subject a pharmaceu geldanamycin, gentamicin, grepafloxacin, herbimycin, imi tical composition comprising an anti-fungal agent. Anti 65 penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin fungal agents are known to the art and discussed Supra. In an eZolid, lomefloxacin, meropenem, meticillin, metronidazole, aspect, the method can comprise orally administering to the meZlocillin, minocycline, mitomycin, moxifloxacin, mupi US 9,707,229 B2 89 90 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor In an aspect, the Subject has been diagnosed with or is floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy Suspected of having a bacterial infection that affects at least cin, penicillin G, penicillin V, piperacillin, pivmecillinam, part of one or both feet. In an aspect, the subject has been platensimycin, polymyxin B, prontosil, pvampicillin, diagnosed with or is Suspected of having a fungal infection pyrazinamide, quinupristin/dalfopristin, rifampicin, rifam- 5 that affects at least part of one or both feet. In an aspect, the pin, roXithromycin, sparfloxacin, spectinomycin, spiramy Subject has been diagnosed with or is suspected of having a cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox bacterial infection and a fungal infection that affect at least azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, part of one or both feet. Sultamicillin, tellithromycin, tetracycline, thiamphenicol, In an aspect, the Subject can have diabetes. In an aspect, 10 the Subject can be obese. In an aspect, the Subject can have ticarcillin, tobramycin, trimethoprim, trimethoprim-sul poor blood flow. In an aspect, the Subject can routinely wear famethoxazole, troleandomycin, trovafloxacin, or a combi thick Socks. In an aspect, the Subject can routinely wear nation thereof. heavy boots. In an aspect of a disclosed method, the anti-bacterial agent In an aspect, contacting can comprise placing at least part can comprise mupirocin. 15 of one or both feet of the subject in the foot bath. In an In an aspect of a disclosed method, the anti-bacterial agent aspect, contacting can comprise placing at least part of one can comprise azithromycin. or both feet of the subject in the foot bath for about 5 to In an aspect, the anti-fungal agent can comprise aba about 15 minutes. In an aspect, contacting can comprise fungin, albaconazole, amorolfin, amphotericin b, anidula placing at least part of one or both feet of the subject in the fungin, bifonazole, butenafine, butoconazole, candicidin, foot bath for about 10 minutes. caspofungin, ciclopiroX, clotrimazole, econazole, fenticon In an aspect, the method can comprise repeating steps azole, filipin, fluconazole, flucytosine, griseofulvin, halo (i)-(iv) daily. In an aspect, the method can comprise repeat progin, hamycin, isavuconazole, isoconazole, itraconazole, ing steps (i)-(iv) daily until the bacterial infection or Sus ketoconazole, micafungin, miconazole, naftifine, natamycin, pected bacterial infection can be eradicated. In an aspect, the nystatin, omoconazole, oxiconazole, polygodial, posacon 25 method can comprise repeating steps (i)-(iv) daily until the azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, fungal infection or Suspected fungal infection can be eradi terbinafine, terconazole, tioconazole, tolnaftate, undecylenic cated. In an aspect, the method can comprise repeating steps acid, Voriconazole, or a combination thereof. (i)-(iv) daily until the infection or the suspected infection In an aspect of a disclosed method, the anti-fungal agent can be eradicated. can comprise fluconazole. In an aspect of a disclosed 30 In an aspect, the method can comprise heating the water method, the anti-fungal agent can comprise itraconazole. In contained within the foot bath. an aspect of a disclosed method, the anti-fungal agent can In an aspect, a foot bath can comprise a mechanical comprise nystatin. agitation agent to mechanically agitate the enclosed water, a In an aspect of a disclosed method, the anti-bacterial agent heating agent to heat the enclosed water, or both. Mechani can comprise mupirocin and the anti-fungal agent can com 35 cal agitation agents and/or means to agitate water within a prise itraconazole. In an aspect of a disclosed method, the compartment are known to the art. In an aspect, a mechani anti-bacterial agent can comprise azithromycin and the cal agitation agent can be a motorized agitation agent. In an anti-fungal agent can comprise fluconazole. In an aspect of aspect, an agitation agent or an agitator can be coupled to a disclosed method, the anti-bacterial agent can comprise both a motor and the foot bath. Motors and agitators are mupirocin and the anti-fungal agent can comprise nystatin. 40 known to the art. In an aspect, mechanical agitation can In an aspect, the amount of the anti-bacterial agent added serve to distribute the anti-bacterial agent or the anti-fungal to the water compared to the amount of the anti-fungal agent agent or both throughout the water contained within the foot added to the water can be from about 1:4 to about 4:1. In an bath. Heating agents and/or means to heat water in a aspect, the ratio can be about 1:1. In an aspect, the ratio of compartment are known to the art. the anti-bacterial agent to the anti-fungal agent be about 45 In an aspect, the method can comprise adding to the water 1.25:1. See, e.g., Table 1. an excipient base powder comprising a blend of micronized In an aspect, the amount of the anti-bacterial agent can be Xylitol and poloxamers. In an aspect, the excipient base from about 125 mg to about 2000 mg. In an aspect, the powder can comprise LoxasperseTM excipient base powder. amount of the anti-fungal agent can be from about 125 mg In an aspect, the excipient base powder can comprise to about 2000 mg. 50 LoxasperseTM excipient base powder and XyliFosTM excipi In an aspect of a disclosed method, the amount of the ent base powder. In an aspect, an excipient base powder can anti-bacterial agent can be about 250 mg and the amount of be obtained from a bulk source. the anti-fungal agent can be about 250 mg. In an aspect of In an aspect, the method can comprise orally administer a disclosed method, the amount of the anti-bacterial agent ca ing to the Subject a pharmaceutical composition comprising be about 250 mg and the amount of the anti-fungal agent can 55 an anti-bacterial agent. Anti-bacterial agents are known to be about 500 mg. In an aspect of a disclosed method, the the art and discussed Supra. In an aspect, the method can amount of the anti-bacterial agent can be about 500 mg and comprise orally administering to the Subject a pharmaceu the amount of the anti-fungal agent can be about 500 mg. In tical composition comprising an anti-fungal agent. Anti an aspect of a disclosed method, the amount of the anti fungal agents are known to the art and discussed Supra. In an bacterial agent can be about 1000 mg and the amount of the 60 aspect, the method can comprise orally administering to the anti-fungal agent can be about 500 mg. Subject a pharmaceutical composition comprising an anti In an aspect, the method can comprise adding a diluent to bacterial agent and a pharmaceutical composition compris the water contained in the foot bath. In an aspect, the diluent ing an anti-fungal agent. can comprise Sodium hypochlorite. In an aspect, the diluent In an aspect, the method can comprise adding to the water can comprise Dakin's Solution. In an aspect, the amount of 65 one or more additional anti-infective agents. In an aspect, diluent can be about 3.75 mL to about 60 mL. In an aspect, the additional anti-infective agent can be a dry powder. In an the amount of diluent can be about 15 mL. aspect, the additional anti-infective agent can be an oint US 9,707,229 B2 91 ment. The additional anti-infective agent can be pure or cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefdi Substantially pure. The additional anti-infective agent can be toren, cefepime, cefixime, cefoperaZone, cefotaxime, obtained from a bulk source. In an aspect, the additional cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, anti-infective agent can be an anti-bacterial agent. Anti ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cepha bacterial agents are known to the art and discussed Supra. In 5 lexin, chloramphenicol, chlorhexidine, ciprofloxacin, an aspect, the additional anti-infective agent can be an clarithromycin, clavulanic acid, clindamycin, cloxacillin, anti-fungal agent. Anti-fungal agents are known to the art colimycin, colistimethate teicoplanin, colistin, demeclocy and discussed Supra. cline, dicloxacillin, dirithromycin, doripenem, doxycycline, In an aspect, a disclosed anti-bacterial agent can be efprozil, enoxacin, ertapenem, erythromycin, ethambutol, encapsulated in one or more capsules. In an aspect, the one 10 flucloxacillin, fosfomycin, furazolidone, gatifloxacin, or more capsules comprising the anti-bacterial agent can be geldanamycin, gentamicin, grepafloxacin, herbimycin, imi added to the water contained within the foot bath. In an penem, isoniazid, kanamycin, levofloxacin, lincomycin, lin aspect, the one or more capsules can disintegrate and the eZolid, lomefloxacin, meropenem, meticillin, metronidazole, anti-bacterial agent can be dissolved in the water contained meZlocillin, minocycline, mitomycin, moxifloxacin, mupi within the foot bath. In an aspect, a Subject can open or break 15 rocin, nafcillin, neomycin, netilmicin, nitrofurantoin, nor apart the one or more capsule and pour the contents of the floxacin, ofloxacin, oxacillin, oxytetracycline, paromomy opened or broken capsules into the water contained within a cin, penicillin G, penicillin V, piperacillin, pivmecillinam, foot bath. platensimycin, polymyxin B, prontosil, pvampicillin, In an aspect, a disclosed an anti-fungal agent can be pyrazinamide, quinupristin?dalfopristin, rifampicin, rifam encapsulated in one or more capsules. In an aspect, the one pin, roXithromycin, sparfloxacin, spectinomycin, spiramy or more capsules comprising the anti-fungal agent can be cin, Sulbactam, Sulfacetamide, Sulfamethizole, Sulfamethox added to the water contained within the foot bath. In an azole, Sulfanilimide, Sulfisoxazole, Sulphonamides, aspect, the one or more capsules can disintegrate and the Sultamicillin, tellithromycin, tetracycline, thiamphenicol, anti-fungal can be dissolved in the water contained within ticarcillin, tobramycin, trimethoprim, trimethoprim-sul the foot bath. In an aspect, a Subject can open or break apart 25 famethoxazole, troleandomycin, trovafloxacin, or a combi the one or more capsule and pour the contents of the opened nation thereof. or broken capsules into the water contained within a foot In an aspect of a disclosed method, the anti-bacterial agent bath. can comprise mupirocin. In an aspect of a disclosed method, In an aspect, a disclosed method can comprise emptying the anti-bacterial agent can comprise azithromycin. the water from the foot bath. In an aspect, a disclosed 30 In an aspect, the anti-fungal agent can comprise aba method can comprise cleaning the foot bath. In an aspect, a fungin, albaconazole, amorolfin, amphotericin b, anidula disclosed method can comprise drying the foot bath. fungin, bifonazole, butenafine, butoconazole, candicidin, In an aspect, a disclosed method can treat or prevent an caspofungin, ciclopiroX, clotrimazole, econazole, fenticon infection affecting the skin of at least a portion of a subjects azole, filipin, fluconazole, flucytosine, griseofulvin, halo foot or feet. In an aspect, a disclosed method can treat or 35 progin, hamycin, isavuconazole, isoconazole, itraconazole, prevent an infection affecting the nail of at least one toe on ketoconazole, micafungin, miconazole, naftifine, natamycin, a subjects foot or feet. nystatin, omoconazole, oxiconazole, polygodial, posacon Disclosed herein a method of treating or preventing an azole, ravuconazole, rimocidin, Sertaconazole, Sulconazole, infection, the method comprising: (i) mixing an anti-bacte terbinafine, terconazole, tioconazole, tolnaftate, undecylenic rial agent, an anti-fungal agent, and a diluent to form a 40 acid, Voriconazole, or a combination thereof. Solution; (ii) adding the solution to water contained within a In an aspect of a disclosed method, the anti-fungal agent foot bath; (iii) agitating the water contained within the foot can comprise fluconazole. In an aspect of a disclosed bath; and (iv) contacting the agitated water with at least part method, the anti-fungal agent can comprise itraconazole. In of one or both feet of a subject. an aspect of a disclosed method, the anti-fungal agent can In an aspect, the anti-bacterial agent, the anti-fungal 45 comprise nystatin. agent, and the diluent can be mixed in a mixing container. In In an aspect of a disclosed method, the anti-bacterial agent an aspect, a mixing container can have a pre-determined size can comprise mupirocin and the anti-fungal agent can com that can measure or hold a pre-determined amount or prise itraconazole. In an aspect of a disclosed method, the Volume. For example, in an aspect, a mixing container can anti-bacterial agent can comprise azithromycin and the measure or hold an amount of about 1 ounces to about 30 50 anti-fungal agent can comprise fluconazole. In an aspect of ounces. In an aspect, the mixing container can hold about 6 a disclosed method, the anti-bacterial agent can comprise ounces. In an aspect, the mixing container can hold about 16 mupirocin and the anti-fungal agent can comprise nystatin. OCCS, In an aspect, the amount of the anti-bacterial agent added In an aspect, the anti-bacterial agent be a dry powder. In to the diluent compared to the amount of the anti-fungal an aspect, the anti-bacterial agent can be an ointment. In an 55 agent added to the diluent can be from about 1:4 to about aspect, the anti-bacterial agent can be obtained from a bulk 4:1. In an aspect, the ratio can be about 1:1. In an aspect, the Source. The anti-bacterial agent can be pure or Substantially ratio of the anti-bacterial agent to the anti-fungal agent be pure. about 1.25:1. See, e.g., Table 1. In an aspect, the anti-fungal agent be a dry powder. In an In an aspect, the amount of the anti-bacterial agent can be aspect, the anti-fungal agent can be an ointment. In an 60 from about 125 mg to about 2000 mg. In an aspect, the aspect, the anti-fungal agent can be obtained from a bulk amount of the anti-fungal agent can be from about 125 mg Source. The anti-fungal agent can be pure or Substantially to about 2000 mg. In an aspect of a disclosed method, the pure. amount of the anti-bacterial agent can be about 250 mg and In an aspect, the anti-bacterial agent can comprise the amount of the anti-fungal agent can be about 250 mg. In afenide, amikacin, amoxicillin, amplicillin, arsphenamine, 65 an aspect of a disclosed method, the amount of the anti azithromycin, aZlocillin, aztreonam, bacampicillin, bacitra bacterial agent ca be about 250 mg and the amount of the cin, carbacephem (loracarbef), carbenicillin, cefaclor, anti-fungal agent can be about 500 mg. In an aspect of a US 9,707,229 B2 93 94 disclosed method, the amount of the anti-bacterial agent can fungal agents are known to the art and discussed Supra. In an be about 500 mg and the amount of the anti-fungal agent can aspect, the method can comprise orally administering to the be about 500 mg. In an aspect of a disclosed method, the Subject a pharmaceutical composition comprising an anti amount of the anti-bacterial agent can be about 1000 mg and bacterial agent and a pharmaceutical composition compris the amount of the anti-fungal agent can be about 500 mg. ing an anti-fungal agent. In an aspect, the diluent can comprise sodium hypochlo In an aspect, the method can comprise adding to the rite. In an aspect, the diluent can comprise Dakin's solution. diluent or to the water one or more additional anti-infective In an aspect, the amount of diluent can be about 3.75 mL to agents. In an aspect, the additional anti-infective agent can about 60 mL. In an aspect, the amount of diluent can be be a dry powder. In an aspect, the additional anti-infective about 15 mL. 10 agent can be an ointment. The additional anti-infective agent In an aspect, the Subject has been diagnosed with or is can be pure or Substantially pure. The additional anti Suspected of having a bacterial infection that affects at least infective agent can be obtained from a bulk source. In an part of one or both feet. In an aspect, the subject has been aspect, the additional anti-infective agent can be an anti diagnosed with or is Suspected of having a fungal infection bacterial agent. Anti-bacterial agents are known to the art that affects at least part of one or both feet. In an aspect, the 15 and discussed Supra. In an aspect, the additional anti Subject has been diagnosed with or is Suspected of having a infective agent can be an anti-fungal agent. Anti-fungal bacterial infection and a fungal infection that affect at least agents are known to the art and discussed Supra. part of one or both feet. In an aspect, a disclosed anti-bacterial agent can be In an aspect, the Subject can have diabetes. In an aspect, encapsulated in one or more capsules. In an aspect, the one the Subject can be obese. In an aspect, the Subject can have or more capsules comprising the anti-bacterial agent can be poor blood flow. In an aspect, the Subject can routinely wear added to the diluent. In an aspect, the one or more capsules thick Socks. In an aspect, the Subject can routinely wear can diluent. In an aspect, a Subject can open or break apart heavy boots. the one or more capsule and pour the contents of the opened In an aspect, contacting can comprise placing at least part or broken capsules into the diluent. of one or both feet of the subject in the foot bath. In an 25 In an aspect, a disclosed an anti-fungal agent can be aspect, contacting can comprise placing at least part of one encapsulated in one or more capsules. In an aspect, the one or both feet of the subject in the foot bath for about 5 to or more capsules comprising the anti-fungal agent can be about 15 minutes. In an aspect, contacting can comprise added to the diluent. In an aspect, the one or more capsules placing at least part of one or both feet of the subject in the can disintegrate and the anti-fungal can be dissolved in the foot bath for about 10 minutes. 30 diluent. In an aspect, a Subject can open or break apart the In an aspect, the method can comprise repeating steps one or more capsule and pour the contents of the opened or (i)-(iv) daily. In an aspect, the method can comprise repeat broken capsules into the diluent. ing steps (i)-(iv) daily until the bacterial infection or Sus In an aspect, a disclosed method can comprise emptying pected bacterial infection can be eradicated. In an aspect, the the water from the foot bath. In an aspect, a disclosed method can comprise repeating steps (i)-(iv) daily until the 35 method can comprise cleaning the foot bath. In an aspect, a fungal infection or Suspected fungal infection can be eradi disclosed method can comprise drying the foot bath. cated. In an aspect, the method can comprise repeating steps In an aspect, a disclosed method can treat or prevent an (i)-(iv) daily until the infection or the suspected infection infection affecting the skin of at least a portion of a subjects can be eradicated. foot or feet. In an aspect, a disclosed method can treat or In an aspect, the method can comprise heating the water 40 prevent an infection affecting the nail of at least one toe on contained within the foot bath. a subjects foot or feet. In an aspect, a foot bath can comprise a mechanical 2. Mupirocin and/or Itraconazole Powders agitation agent to mechanically agitate the enclosed water, a Disclosed herein is a method of treating or preventing an heating agent to heat the enclosed water, or both. Mechani infection, the method comprising: (i) adding mupirocin to cal agitation agents and/or means to agitate water within a 45 water contained within a foot bath; (ii) adding an itracon compartment are known to the art. In an aspect, a mechani azole to the water, (iii) agitating the water contained within cal agitation agent can be a motorized agitation agent. In an the foot bath; and (iv) contacting the agitated water with at aspect, an agitation agent or an agitator can be coupled to least a part of one or both feet of a subject. both a motor and the foot bath. Motors and agitators are In an aspect, the mupirocin be a dry powder. In an aspect, known to the art. In an aspect, mechanical agitation can 50 the mupirocin can be an ointment. In an aspect, the mupi serve to distribute the solution throughout the water con rocin can be obtained from a bulk source. The mupirocin can tained within the foot bath. Heating agents and/or means to be pure or Substantially pure. In an aspect, the itraconazole heat water in a compartment are known to the art. be a dry powder. In an aspect, the itraconazole can be an In an aspect, the method can comprise adding to the ointment. In an aspect, the itraconazole can be obtained from diluent or to the water an excipient base powder comprising 55 a bulk source. The itraconazole can be pure or substantially a blend of micronized Xylitol and poloxamers. In an aspect, pure. the excipient base powder can comprise LoxasperseTM In an aspect, the amount of the mupirocin added to the excipient base powder. In an aspect, the excipient base water compared to the amount of the itraconazole added to powder can comprise LoxasperseTM excipient base powder the water can be from about 1:4 to about 4:1. In an aspect, and XyliFosTM excipient base powder. In an aspect, an 60 the ratio of the mupirocin to the itraconazole can be about excipient base powder can be obtained from a bulk source. 1:1. In an aspect, the ratio of the mupirocin to the itracon In an aspect, the method can comprise orally administer azole can be about 1.25:1. See, e.g., Table 1. ing to the Subject a pharmaceutical composition comprising In an aspect, the amount of the mupirocin can be from an anti-bacterial agent. Anti-bacterial agents are known to about 125 mg to about 2000 mg. In an aspect, the amount of the art and discussed Supra. In an aspect, the method can 65 the itraconazole can be from about 125 mg to about 2000 comprise orally administering to the Subject a pharmaceu mg. In an aspect, the amount of the mupirocin can be about tical composition comprising an anti-fungal agent. Anti 500 mg and the amount of the itraconazole can be about 500 US 9,707,229 B2 95 96 mg. In an aspect, the amount of the mupirocin can be about obtained from a bulk source. In an aspect, the additional 1000 mg and the amount of the itraconazole can be about anti-infective agent can be an anti-bacterial agent. Anti 500 mg. bacterial agents are known to the art and discussed Supra. In In an aspect, the method can comprise adding a diluent to an aspect, the additional anti-infective agent can be an the water contained in the foot bath. In an aspect, the diluent 5 anti-fungal agent. Anti-fungal agents are known to the art can comprise Sodium hypochlorite. In an aspect, the diluent and discussed Supra. can comprise Dakin's Solution. In an aspect, the amount of In an aspect, the method can comprise orally administer diluent can be about 3.75 mL to about 60 mL. In an aspect, ing to the Subject a pharmaceutical composition comprising the amount of diluent can be about 15 mL. an anti-bacterial agent. Anti-bacterial agents are known to In an aspect, the Subject has been diagnosed with or is 10 Suspected of having a bacterial infection that affects at least the art and discussed Supra. In an aspect, the method can part of one or both feet. In an aspect, the subject has been comprise orally administering to the Subject a pharmaceu diagnosed with or is Suspected of having a fungal infection tical composition comprising an anti-fungal agent. Anti that affects at least part of one or both feet. In an aspect, the fungal agents are known to the art and discussed Supra. In an Subject has been diagnosed with or is Suspected of having a 15 aspect, the method can comprise orally administering to the bacterial infection and a fungal infection that affect at least Subject a pharmaceutical composition comprising an anti part of one or both feet. bacterial agent and a pharmaceutical composition compris In an aspect, the Subject can have diabetes. In an aspect, ing an anti-fungal agent. the Subject can be obese. In an aspect, the Subject can have In an aspect, the mupirocin can be encapsulated in one or poor blood flow. In an aspect, the Subject can routinely wear more capsules. In an aspect, the one or more capsules thick Socks. In an aspect, the Subject can routinely wear comprising the mupirocin can be added to the water con heavy boots. tained within the foot bath. In an aspect, the one or more In an aspect, contacting can comprise placing at least part capsules can disintegrate and the mupirocin can be dissolved of one or both feet of the subject in the foot bath. In an in the water contained within the foot bath. In an aspect, a aspect, contacting can comprise placing at least part of one 25 Subject can open or break apart the one or more capsule and or both feet of the subject in the foot bath for about 5 to pour the contents of the opened or broken capsules into the about 15 minutes. In an aspect, contacting can comprise water contained within a foot bath. placing at least part of one or both feet of the subject in the In an aspect, the itraconazole can be encapsulated in one foot bath for about 10 minutes. or more capsules. In an aspect, the one or more capsules In an aspect, the method can comprise repeating steps 30 (i)-(iv) daily. In an aspect, the method can comprise repeat comprising the itraconazole can be added to the water ing steps (i)-(iv) daily until the bacterial infection or sus contained within the foot bath. In an aspect, the one or more pected bacterial infection can be eradicated. In an aspect, the capsules can disintegrate and the itraconazole can be dis method can comprise repeating steps (i)-(iv) daily until the solved in the water contained within the foot bath. In an fungal infection or Suspected fungal infection can be eradi 35 aspect, a Subject can open or break apart the one or more cated. In an aspect, the method can comprise repeating steps capsule and pour the contents of the opened or broken (i)-(iv) daily until the infection or the suspected infection capsules into the water contained within a foot bath. can be eradicated. In an aspect, a disclosed method can comprise emptying In an aspect, the method can comprise heating the water the water from the foot bath. In an aspect, a disclosed contained within the foot bath. 40 method can comprise cleaning the foot bath. In an aspect, a In an aspect, a foot bath can comprise a mechanical disclosed method can comprise drying the foot bath. agitation agent to mechanically agitate the enclosed water, a In an aspect, a disclosed method can treat or prevent an heating agent to heat the enclosed water, or both. Mechani infection affecting the skin of at least a portion of a subjects cal agitation agents and/or means to agitate water within a foot or feet. In an aspect, a disclosed method can treat or compartment are known to the art. In an aspect, a mechani 45 prevent an infection affecting the nail of at least one toe on cal agitation agent can be a motorized agitation agent. In an a subjects foot or feet. aspect, an agitation agent or an agitator can be coupled to Disclosed herein a method of treating or preventing an both a motor and the foot bath. Motors and agitators are infection, the method comprising: (i) mixing mupirocin, known to the art. In an aspect, mechanical agitation can itraconazole, and a diluent to form a solution; (ii) adding the serve to distribute the mupirocin or the itraconazole or both 50 Solution to water contained within a foot bath; (iii) agitating throughout the water contained within the foot bath. Heating the water contained within the foot bath; and (iv) contacting agents and/or means to heat water in a compartment are the agitated water with at least part of one or both feet of a known to the art. Subject. In an aspect, the method can comprise adding to the water In an aspect, the mupirocin can be a dry powder. In an an excipient base powder comprising a blend of micronized 55 Xylitol and poloxamers. In an aspect, the excipient base aspect, the mupirocin can be an ointment. In an aspect, the powder can comprise LoxasperseTM excipient base powder. mupirocin can be obtained from a bulk source. The mupi In an aspect, the excipient base powder can comprise rocin can be pure or Substantially pure. LoxasperseTM excipient base powder and XyliFosTM excipi In an aspect, the itraconazole can be a dry powder. In an ent base powder. In an aspect, an excipient base powder can 60 aspect, the itraconazole can be an ointment. In an aspect, the be obtained from a bulk source. itraconazole can be obtained from a bulk source. The In an aspect, the method can comprise adding to the water itraconazole can be pure or Substantially pure. one or more additional anti-infective agents. In an aspect, In an aspect, the amount of the mupirocin used compared the additional anti-infective agent can be a dry powder. In an to the amount of the itraconazole used can be from about 1:4 aspect, the additional anti-infective agent can be an oint 65 to about 4:1. In an aspect, the ratio can be about 1:1. In an ment. The additional anti-infective agent can be pure or aspect, the ratio of the mupirocin to the itraconazole can be Substantially pure. The additional anti-infective agent can be about 1.25:1. See, e.g., Table 1. US 9,707,229 B2 97 98 In an aspect, the amount of the mupirocin can be from In an aspect, the method can comprise adding to the about 125 mg to about 2000 mg. In an aspect, the amount of Solution or to the water an excipient base powder comprising the itraconazole can be from about 125 mg to about 2000 a blend of micronized Xylitol and poloxamers. In an aspect, ng. the excipient base powder can comprise LoxasperseTM In an aspect, the amount of the mupirocin can be about excipient base powder. In an aspect, the excipient base 500 mg and the amount of the itraconazole can be about 500 powder can comprise LoxasperseTM excipient base powder mg. In an aspect, the amount of the mupirocin can be about and XyliFosTM excipient base powder. In an aspect, an 1000 mg and the amount of the itraconazole can be about excipient base powder can be obtained from a bulk source. 1000 mg. In an aspect, the amount of the mupirocin can be In an aspect, the method can comprise adding to the about 1000 mg and the amount of the itraconazole can be 10 solution or to the water one or more additional anti-infective about 500 mg. agents. In an aspect, the additional anti-infective agent can In an aspect, the mupirocin, the itraconazole, and the be a dry powder. In an aspect, the additional anti-infective diluent can be mixed in a mixing container. In an aspect, a agent can be an ointment. The additional anti-infective agent mixing container can have a pre-determined size that can can be pure or Substantially pure. The additional anti measure or hold a pre-determined amount or Volume. For 15 infective agent can be obtained from a bulk source. In an example, in an aspect, a mixing container can measure or aspect, the additional anti-infective agent can be an anti hold an amount of about 1 ounces to about 30 ounces. In an bacterial agent. Anti-bacterial agents are known to the art aspect, the mixing container can hold about 6 ounces. In an and discussed Supra. In an aspect, the additional anti aspect, the mixing container can hold about 16 ounces. infective agent can be an anti-fungal agent. Anti-fungal In an aspect, the diluent can comprise sodium hypochlo agents are known to the art and discussed Supra. rite. In an aspect, the diluent can comprise Dakin's solution. In an aspect, the method can comprise orally administer In an aspect, the amount of diluent can be about 3.75 mL to ing to the Subject a pharmaceutical composition comprising about 60 mL. In an aspect, the amount of diluent can be an anti-bacterial agent. Anti-bacterial agents are known to about 15 mL. the art and discussed Supra. In an aspect, the method can In an aspect, the Subject has been diagnosed with or is 25 comprise orally administering to the Subject a pharmaceu Suspected of having a bacterial infection that affects at least tical composition comprising an anti-fungal agent. Anti part of one or both feet. In an aspect, the subject has been fungal agents are known to the art and discussed Supra. In an diagnosed with or is Suspected of having a fungal infection aspect, the method can comprise orally administering to the that affects at least part of one or both feet. In an aspect, the Subject a pharmaceutical composition comprising an anti Subject has been diagnosed with or is Suspected of having a 30 bacterial agent and a pharmaceutical composition compris bacterial infection and a fungal infection that affect at least ing an anti-fungal agent. part of one or both feet. In an aspect, the mupirocin can be encapsulated in one or In an aspect, the Subject can have diabetes. In an aspect, more capsules. In an aspect, the one or more capsules the Subject can be obese. In an aspect, the Subject can have comprising the mupirocin can be added to the diluent. In an poor blood flow. In an aspect, the Subject can routinely wear 35 aspect, the one or more capsules can disintegrate and the thick Socks. In an aspect, the Subject can routinely wear mupirocin can be dissolved in the diluent. In an aspect, a heavy boots. Subject can open or break apart the one or more capsule and In an aspect, contacting can comprise placing at least part pour the contents of the opened or broken capsules into the of one or both feet of the subject in the foot bath. In an diluent. aspect, contacting can comprise placing at least part of one 40 In an aspect, the itraconazole can be encapsulated in one or both feet of the subject in the foot bath for about 5 to or more capsules. In an aspect, the one or more capsules about 15 minutes. In an aspect, contacting can comprise comprising the itraconazole can be added to the diluent. In placing at least part of one or both feet of the subject in the an aspect, the one or more capsules can disintegrate and the foot bath for about 10 minutes. itraconazole can be dissolved in the diluent. In an aspect, a In an aspect, the method can comprise repeating steps 45 Subject can open or break apart the one or more capsule and (i)-(iv) daily. In an aspect, the method can comprise repeat pour the contents of the opened or broken capsules into the ing steps (i)-(iv) daily until the bacterial infection or Sus diluent. pected bacterial infection can be eradicated. In an aspect, the In an aspect, a disclosed method can comprise emptying method can comprise repeating steps (i)-(iv) daily until the the water from the foot bath. In an aspect, a disclosed fungal infection or Suspected fungal infection can be eradi 50 method can comprise cleaning the foot bath. In an aspect, a cated. In an aspect, the method can comprise repeating steps disclosed method can comprise drying the foot bath. (i)-(iv) daily until the infection or the suspected infection In an aspect, a disclosed method can treat or prevent an can be eradicated. infection affecting the skin of at least a portion of a subjects In an aspect, the method can comprise heating the water foot or feet. In an aspect, a disclosed method can treat or contained within the foot bath. 55 prevent an infection affecting the nail of at least one toe on In an aspect, a foot bath can comprise a mechanical a subjects foot or feet. agitation agent to mechanically agitate the enclosed water, a 3. Azithromycin and/or Fluconazole Powders heating agent to heat the enclosed water, or both. Mechani Disclosed herein is a method of treating or preventing an cal agitation agents and/or means to agitate water within a infection, the method comprising: (i) adding azithromycinto compartment are known to the art. In an aspect, a mechani 60 water contained within a foot bath; (ii) adding fluconazole to cal agitation agent can be a motorized agitation agent. In an the water, (iii) agitating the water contained within the foot aspect, an agitation agent or an agitator can be coupled to bath; and (iv) contacting the agitated water with at least a both a motor and the foot bath. Motors and agitators are part of one or both feet of a subject. known to the art. In an aspect, mechanical agitation can In an aspect, the azithromycin be a dry powder. In an serve to distribute the solution throughout the water con 65 aspect, the azithromycin can be an ointment. In an aspect, tained within the foot bath. Heating agents and/or means to the azithromycin can be obtained from a bulk source. The heat water in a compartment are known to the art. azithromycin can be pure or Substantially pure. US 9,707,229 B2 99 100 In an aspect, the fluconazole be a dry powder. In an aspect, both throughout the water contained within the foot bath. the fluconazole can be an ointment. In an aspect, the Heating agents and/or means to heat water in a compartment fluconazole can be obtained from a bulk source. The flu are known to the art. conazole can be pure or Substantially pure. In an aspect, the In an aspect, the method can comprise adding to the water amount of the azithromycin added to the water compared to an excipient base powder comprising a blend of micronized the amount of the fluconazole added to the water can be from Xylitol and poloxamers. In an aspect, the excipient base about 1:4 to about 4:1. In an aspect, the ratio can be about powder can comprise LoxasperseTM excipient base powder. 1:1. In an aspect, the ratio of the azithromycin to the In an aspect, the excipient base powder can comprise fluconazole can be about 1.25:1. LoxasperseTM excipient base powder and XyliFosTM excipi In an aspect of a disclosed method, the amount of the 10 ent base powder. In an aspect, an excipient base powder can azithromycin can be about 250 mg and the amount of the be obtained from a bulk source. fluconazole can be about 250 mg. In an aspect of a disclosed In an aspect, the method can comprise orally administer method, the amount of the azithromycin can be about 250 ing to the Subject a pharmaceutical composition comprising mg and the amount of the fluconazole can be about 500 mg. 15 an anti-bacterial agent. Anti-bacterial agents are known to In an aspect of a disclosed method, the amount of the the art and discussed Supra. In an aspect, the method can azithromycin can be about 500 mg and the amount of the comprise orally administering to the Subject a pharmaceu fluconazole can be about 500 mg. In an aspect of a disclosed tical composition comprising an anti-fungal agent. Anti method, the amount of the azithromycin can be about 1000 fungal agents are known to the art and discussed Supra. In an mg and the amount of the fluconazole can be about 500 mg. aspect, the method can comprise orally administering to the In an aspect, the method can comprise adding a diluent to Subject a pharmaceutical composition comprising an anti the water contained in the foot bath. In an aspect, the diluent bacterial agent and a pharmaceutical composition compris can comprise Sodium hypochlorite. In an aspect, the diluent ing an anti-fungal agent. can comprise Dakin's Solution. In an aspect, the amount of In an aspect, the method can comprise adding to the water diluent can be about 3.75 mL to about 60 mL. In an aspect, 25 one or more additional anti-infective agents. In an aspect, the amount of diluent can be about 15 mL. the additional anti-infective agent can be a dry powder. In an In an aspect, the Subject has been diagnosed with or is aspect, the additional anti-infective agent can be an oint Suspected of having a bacterial infection that affects at least ment. The additional anti-infective agent can be pure or part of one or both feet. In an aspect, the subject has been Substantially pure. The additional anti-infective agent can be diagnosed with or is Suspected of having a fungal infection 30 that affects at least part of one or both feet. In an aspect, the obtained from a bulk source. In an aspect, the additional subject has been diagnosed with or is suspected of having a anti-infective agent can be an anti-bacterial agent. Anti bacterial infection and a fungal infection that affect at least bacterial agents are known to the art and discussed Supra. In part of one or both feet. an aspect, the additional anti-infective agent can be an In an aspect, the Subject can have diabetes. In an aspect, 35 anti-fungal agent. Anti-fungal agents are known to the art the Subject can be obese. In an aspect, the Subject can have and discussed Supra. poor blood flow. In an aspect, the Subject can routinely wear In an aspect, the azithromycin can be encapsulated in one thick Socks. In an aspect, the Subject can routinely wear or more capsules. In an aspect, the one or more capsules heavy boots. comprising the azithromycin can be added to the water In an aspect, contacting can comprise placing at least part 40 contained within the foot bath. In an aspect, the one or more of one or both feet of the subject in the foot bath. In an capsules can disintegrate and the azithromycin can be dis aspect, contacting can comprise placing at least part of one solved in the water contained within the foot bath. In an or both feet of the subject in the foot bath for about 5 to aspect, a Subject can open or break apart the one or more about 15 minutes. In an aspect, contacting can comprise capsule and pour the contents of the opened or broken placing at least part of one or both feet of the subject in the 45 capsules into the water contained within a foot bath. foot bath for about 10 minutes. In an aspect, the fluconazole can be encapsulated in one In an aspect, the method can comprise repeating steps or more capsules. In an aspect, the one or more capsules (i)-(iv) daily. In an aspect, the method can comprise repeat comprising the a fluconazole can be added to the water ing steps (i)-(iv) daily until the bacterial infection or Sus contained within the foot bath. In an aspect, the one or more pected bacterial infection can be eradicated. In an aspect, the 50 capsules can disintegrate and the fluconazole can be dis method can comprise repeating steps (i)-(iv) daily until the solved in the water contained within the foot bath. In an fungal infection or Suspected fungal infection can be eradi aspect, a Subject can open or break apart the one or more cated. In an aspect, the method can comprise repeating steps capsule and pour the contents of the opened or broken (i)-(iv) daily until the infection or the suspected infection capsules into the water contained within a foot bath. can be eradicated. 55 In an aspect, a disclosed method can comprise emptying In an aspect, the method can comprise heating the water the water from the foot bath. In an aspect, a disclosed contained within the foot bath. method can comprise cleaning the foot bath. In an aspect, a In an aspect, a foot bath can comprise a mechanical disclosed method can comprise drying the foot bath. agitation agent to mechanically agitate the enclosed water, a In an aspect, a disclosed method can treat or prevent an heating agent to heat the enclosed water, or both. Mechani 60 infection affecting the skin of at least a portion of a subjects cal agitation agents and/or means to agitate water within a foot or feet. In an aspect, a disclosed method can treat or compartment are known to the art. In an aspect, a mechani prevent an infection affecting the nail of at least one toe on cal agitation agent can be a motorized agitation agent. In an a subjects foot or feet. aspect, an agitation agent or an agitator can be coupled to Disclosed herein a method of treating or preventing an both a motor and the foot bath. Motors and agitators are 65 infection, the method comprising: (i) mixing azithromycin, known to the art. In an aspect, mechanical agitation can fluconazole, and a diluent to form a solution; (ii) adding the serve to distribute the azithromycin or the fluconazole or Solution to water contained within a foot bath; (iii) agitating US 9,707,229 B2 101 102 the water contained within the foot bath; and (iv) contacting fungal infection or Suspected fungal infection can be eradi the agitated water with at least part of one or both feet of a cated. In an aspect, the method can comprise repeating steps Subject. (i)-(iv) daily until the infection or the suspected infection In an aspect, the azithromycin be a dry powder. In an can be eradicated. aspect, the azithromycin can be an ointment. In an aspect, In an aspect, the method can comprise heating the water the azithromycin can be obtained from a bulk source. The contained within the foot bath. azithromycin can be pure or Substantially pure. In an aspect, In an aspect, a foot bath can comprise a mechanical the fluconazole be a dry powder. In an aspect, the flucon agitation agent to mechanically agitate the enclosed water, a azole can be an ointment. In an aspect, the fluconazole can heating agent to heat the enclosed water, or both. Mechani be obtained from a bulk source. The fluconazole can be pure 10 cal agitation agents and/or means to agitate water within a or Substantially pure. compartment are known to the art. In an aspect, a mechani In an aspect, the amount of the azithromycin used com cal agitation agent can be a motorized agitation agent. In an pared to the amount of the fluconazole used can be from aspect, an agitation agent or an agitator can be coupled to about 1:4 to about 4:1. In an aspect, the ratio can be about both a motor and the foot bath. Motors and agitators are 1:1. In an aspect, the ratio of the azithromycin to the 15 known to the art. In an aspect, mechanical agitation can fluconazole can be about 1.25:1. serve to distribute the solution the water contained within In an aspect, the amount of the azithromycin can be from the foot bath. Heating agents and/or means to heat water in about 125 mg to about 2000 mg. In an aspect, the amount of a compartment are known to the art. the fluconazole can be from about 125 mg to about 2000 mg. In an aspect, the method can comprise adding to the In an aspect of a disclosed method, the amount of the diluent or to the water an excipient base powder comprising azithromycin can be about 250 mg and the amount of the a blend of micronized Xylitol and poloxamers. In an aspect, fluconazole can be about 250 mg. In an aspect of a disclosed the excipient base powder can comprise LoxasperseTM method, the amount of the azithromycin can be about 250 excipient base powder. In an aspect, the excipient base mg and the amount of the fluconazole can be about 500 mg. powder can comprise LoxasperseTM excipient base powder In an aspect of a disclosed method, the amount of the 25 and XyliFosTM excipient base powder. In an aspect, an azithromycin can be about 500 mg and the amount of the excipient base powder can be obtained from a bulk source. fluconazole can be about 500 mg. In an aspect of a disclosed In an aspect, the method can comprise orally administer method, the amount of the azithromycin can be about 1000 ing to the Subject a pharmaceutical composition comprising mg and the amount of the fluconazole can be about 500 mg. an anti-bacterial agent. Anti-bacterial agents are known to In an aspect, the azithromycin, the fluconazole, and the 30 the art and discussed Supra. In an aspect, the method can diluent can be mixed in a mixing container. In an aspect, a comprise orally administering to the Subject a pharmaceu mixing container can have a pre-determined size that can tical composition comprising an anti-fungal agent. Anti measure or hold a pre-determined amount or Volume. For fungal agents are known to the art and discussed Supra. In an example, in an aspect, a mixing container can measure or aspect, the method can comprise orally administering to the hold an amount of about 1 ounces to about 30 ounces. In an 35 Subject a pharmaceutical composition comprising an anti aspect, the mixing container can hold about 6 ounces. In an bacterial agent and a pharmaceutical composition compris aspect, the mixing container can hold about 16 ounces. ing an anti-fungal agent. In an aspect, the diluent can comprise sodium hypochlo In an aspect, the method can comprise adding to the rite. In an aspect, the diluent can comprise Dakin's solution. diluent or to the water one or more additional anti-infective In an aspect, the amount of diluent can be about 3.75 mL to 40 agents. In an aspect, the additional anti-infective agent can about 60 mL. In an aspect, the amount of diluent can be be a dry powder. In an aspect, the additional anti-infective about 15 mL. agent can be an ointment. The additional anti-infective agent In an aspect, the Subject has been diagnosed with or is can be pure or Substantially pure. The additional anti Suspected of having a bacterial infection that affects at least infective agent can be obtained from a bulk source. In an part of one or both feet. In an aspect, the subject has been 45 aspect, the additional anti-infective agent can be an anti diagnosed with or is Suspected of having a fungal infection bacterial agent. Anti-bacterial agents are known to the art that affects at least part of one or both feet. In an aspect, the and discussed Supra. In an aspect, the additional anti Subject has been diagnosed with or is Suspected of having a infective agent can be an anti-fungal agent. Anti-fungal bacterial infection and a fungal infection that affect at least agents are known to the art and discussed Supra. part of one or both feet. 50 In an aspect, the azithromycin can be encapsulated in one In an aspect, the Subject can have diabetes. In an aspect, or more capsules. In an aspect, the one or more capsules the Subject can be obese. In an aspect, the Subject can have comprising the azithromycin can be added to the water poor blood flow. In an aspect, the Subject can routinely wear contained within the foot bath. In an aspect, the one or more thick Socks. In an aspect, the Subject can routinely wear capsules can disintegrate and the azithromycin can be dis heavy boots. 55 solved in the water contained within the foot bath. In an In an aspect, contacting can comprise placing at least part aspect, a Subject can open or break apart the one or more of one or both feet of the subject in the foot bath. In an capsule and pour the contents of the opened or broken aspect, contacting can comprise placing at least part of one capsules into the water contained within a foot bath. or both feet of the subject in the foot bath for about 5 to In an aspect, the fluconazole can be encapsulated in one about 15 minutes. In an aspect, contacting can comprise 60 or more capsules. In an aspect, the one or more capsules placing at least part of one or both feet of the subject in the comprising the a fluconazole can be added to the water foot bath for about 10 minutes. contained within the foot bath. In an aspect, the one or more In an aspect, the method can comprise repeating steps capsules can disintegrate and the fluconazole can be dis (i)-(iv) daily. In an aspect, the method can comprise repeat solved in the water contained within the foot bath. In an ing steps (i)-(iv) daily until the bacterial infection or Sus 65 aspect, a Subject can open or break apart the one or more pected bacterial infection can be eradicated. In an aspect, the capsule and pour the contents of the opened or broken method can comprise repeating steps (i)-(iv) daily until the capsules into the water contained within a foot bath. US 9,707,229 B2 103 104 In an aspect, a disclosed method can comprise emptying both a motor and the foot bath. Motors and agitators are the water from the foot bath. In an aspect, a disclosed known to the art. In an aspect, mechanical agitation can method can comprise cleaning the foot bath. In an aspect, a serve to distribute the mupirocin and the nystatin or both disclosed method can comprise drying the foot bath. throughout the water contained within the foot bath. Heating In an aspect, a disclosed method can treat or prevent an 5 agents and/or means to heat water in a compartment are infection affecting the skin of at least a portion of a subjects known to the art. foot or feet. In an aspect, a disclosed method can treat or In an aspect, the method can comprise adding to the water prevent an infection affecting the nail of at least one toe on an excipient base powder comprising a blend of micronized a subjects foot or feet. Xylitol and poloxamers. In an aspect, the excipient base 4. Mupirocin and/or Nystatin 10 powder can comprise LoxasperseTM excipient base powder. Disclosed herein is a method of treating or preventing an In an aspect, the excipient base powder can comprise infection, the method comprising: (i) adding mupirocin to LoxasperseTM excipient base powder and XyliFosTM excipi water contained in a foot bath, (ii) adding nystatin to the ent base powder. In an aspect, an excipient base powder can water, (iii) agitating the water contained within the footbath; be obtained from a bulk source. and (iv) contacting the agitated water with at least a part of 15 In an aspect, the method can comprise adding a 22 gram one or both feet of a subject. tube of mupirocin to the water and adding a 15 gram In an aspect, the mupirocin can be a dry powder. In an container of nystatin to the water. aspect, the mupirocin can be obtained from a bulk source. In an aspect, the method can comprise adding to the water The mupirocin can be pure or Substantially pure. In an one or more additional anti-infective agents. In an aspect, aspect, the mupirocin can be an ointment. In an aspect, the the additional anti-infective agent can be a dry powder. In an mupirocin can be a 2% ointment. In an aspect, the mupirocin aspect, the additional anti-infective agent can be an oint can be provided in a tube. For example, in an aspect, the ment. The additional anti-infective agent can be pure or mupirocin can be provided in a 22 gram tube. In an aspect, Substantially pure. The additional anti-infective agent can be the nystatin can be a dry powder. In an aspect, the nystatin obtained from a bulk source. In an aspect, the additional can be an ointment. In an aspect, the nyStatin can be obtained 25 anti-infective agent can be an anti-bacterial agent. Anti from a bulk source. The nystatin can be pure or substantially bacterial agents are known to the art and discussed Supra. In pure. In an aspect, the nystatin can be provided in a an aspect, the additional anti-infective agent can be an container. For example, in an aspect, the nystatin can be anti-fungal agent. Anti-fungal agents are known to the art provided in 15 gram container. and discussed Supra. In an aspect, the Subject has been diagnosed with or is 30 In an aspect, the method can comprise orally administer Suspected of having a bacterial infection that affects at least ing to the Subject a pharmaceutical composition comprising part of one or both feet. In an aspect, the subject has been an anti-bacterial agent. Anti-bacterial agents are known to diagnosed with or is Suspected of having a fungal infection the art and discussed Supra. In an aspect, the method can that affects at least part of one or both feet. In an aspect, the comprise orally administering to the Subject a pharmaceu Subject has been diagnosed with or is Suspected of having a 35 tical composition comprising an anti-fungal agent. Anti bacterial infection and a fungal infection that affect at least fungal agents are known to the art and discussed Supra. In an part of one or both feet. aspect, the method can comprise orally administering to the In an aspect, the Subject can have diabetes. In an aspect, Subject a pharmaceutical composition comprising an anti the Subject can be obese. In an aspect, the Subject can have bacterial agent and a pharmaceutical composition compris poor blood flow. In an aspect, the Subject can routinely wear 40 ing an anti-fungal agent. thick Socks. In an aspect, the Subject can routinely wear In an aspect, a disclosed method can comprise emptying heavy boots. the water from the foot bath. In an aspect, a disclosed In an aspect, contacting can comprise placing at least part method can comprise cleaning the foot bath. In an aspect, a of one or both feet of the subject in the foot bath. In an disclosed method can comprise drying the foot bath. aspect, contacting can comprise placing at least part of one 45 In an aspect, a disclosed method can treat or prevent an or both feet of the subject in the foot bath for about 5 to infection affecting the skin of at least a portion of a subjects about 15 minutes. In an aspect, contacting can comprise foot or feet. In an aspect, a disclosed method can treat or placing at least part of one or both feet of the subject in the prevent an infection affecting the nail of at least one toe on foot bath for about 10 minutes. a subjects foot or feet. In an aspect, the method can comprise repeating steps 50 Disclosed herein is a method of treating or preventing an (i)-(iv) daily. In an aspect, the method can comprise repeat infection, the method comprising: (i) adding mupirocin to a ing steps (i)-(iv) daily until the bacterial infection or Sus mixing container, (ii) adding nystatin to the mixing con pected bacterial infection can be eradicated. In an aspect, the tainer, (iii) adding a diluent to the mixing container, (iv) method can comprise repeating steps (i)-(iv) daily until the mixing the mupirocin, nystatin, and diluent in the mixing fungal infection or Suspected fungal infection can be eradi 55 container to form a solution, (v) adding the solution to water cated. In an aspect, the method can comprise repeating steps contained within a foot bath; (vi) agitating the water con (i)-(iv) daily until the infection or the suspected infection tained within the foot bath; and (vii) contacting the agitated can be eradicated. water with at least a part of one or both feet of a subject. In an aspect, the method can comprise heating the water In an aspect, the mixing container can have a pre contained within the foot bath. 60 determined size that can measure or hold a pre-determined In an aspect, a foot bath can comprise a mechanical amount or volume. For example, in an aspect, a mixing agitation agent to mechanically agitate the enclosed water, a container can measure or hold an amount of about 1 ounces heating agent to heat the enclosed water, or both. Mechani to about 30 ounces. In an aspect, the mixing container can cal agitation agents and/or means to agitate water within a hold about 6 ounces. In an aspect, the mixing container can compartment are known to the art. In an aspect, a mechani 65 hold about 16 ounces. cal agitation agent can be a motorized agitation agent. In an In an aspect, the diluent can comprise Sodium hypochlo aspect, an agitation agent or an agitator can be coupled to rite. In an aspect, the diluent can comprise Dakin's solution. US 9,707,229 B2 105 106 In an aspect, the amount of diluent can be about 3.75 mL to In an aspect, the method can comprise adding a 22 gram about 60 mL. In an aspect, the amount of diluent can be tube of mupirocin to the mixing container and adding a 15 about 15 mL. gram container of nystatin to the mixing container. In an aspect, the Subject has been diagnosed with or is Suspected of having a bacterial infection that affects at least In an aspect, adding the mupirocinto the mixing container part of one or both feet. In an aspect, the subject has been can comprise attaching a key (e.g., a metal key) to an end of diagnosed with or is Suspected of having a fungal infection a tube of mupirocin and sliding the key down the length of that affects at least part of one or both feet. In an aspect, the the tube towards the aperture of the tube, thereby forcing the Subject has been diagnosed with or is Suspected of having a contents of the tube into the mixing container. bacterial infection and a fungal infection that affect at least 10 In an aspect, the method can comprise adding to the part of one or both feet. mixing container or to the water one or more additional In an aspect, the Subject can have diabetes. In an aspect, anti-infective agents. In an aspect, the additional anti-infec the Subject can be obese. In an aspect, the Subject can have tive agent can be a dry powder. In an aspect, the additional poor blood flow. In an aspect, the Subject can routinely wear anti-infective agent can be an ointment. The additional thick Socks. In an aspect, the Subject can routinely wear 15 anti-infective agent can be pure or Substantially pure. The heavy boots. additional anti-infective agent can be obtained from a bulk In an aspect, contacting can comprise placing at least part Source. In an aspect, the additional anti-infective agent can of one or both feet of the subject in the foot bath. In an aspect, contacting can comprise placing at least part of one be an anti-bacterial agent. Anti-bacterial agents are known to or both feet of the subject in the foot bath for about 5 to the art and discussed Supra. In an aspect, the additional about 15 minutes. In an aspect, contacting can comprise anti-infective agent can be an anti-fungal agent. Anti-fungal placing at least part of one or both feet of the subject in the agents are known to the art and discussed Supra. foot bath for about 10 minutes. In an aspect, the method can comprise orally administer In an aspect, the method can comprise repeating steps ing to the Subject a pharmaceutical composition comprising (i)-(vii) daily. In an aspect, the method can comprise repeat 25 an anti-bacterial agent. Anti-bacterial agents are known to ing steps (i)-(vii) daily until the bacterial infection or Sus the art and discussed Supra. In an aspect, the method can pected bacterial infection can be eradicated. In an aspect, the comprise orally administering to the Subject a pharmaceu method can comprise repeating steps (i)-(vii) daily until the tical composition comprising an anti-fungal agent. Anti fungal infection or Suspected fungal infection can be eradi fungal agents are known to the art and discussed Supra. In an cated. In an aspect, the method can comprise repeating steps 30 aspect, the method can comprise orally administering to the (i)-(vii) daily until the infection or the suspected infection Subject a pharmaceutical composition comprising an anti can be eradicated. bacterial agent and a pharmaceutical composition compris In an aspect, the method can comprise heating the water ing an anti-fungal agent. contained within the foot bath. In an aspect, a foot bath can comprise a mechanical 35 In an aspect, the mupirocin can be encapsulated in one or agitation agent to mechanically agitate the enclosed water, a more capsules. In an aspect, the one or more capsules heating agent to heat the enclosed water, or both. Mechani comprising the mupirocin can be added to the diluent. In an cal agitation agents and/or means to agitate water within a aspect, the one or more capsules can disintegrate and the compartment are known to the art. In an aspect, a mechani mupirocin can be dissolved in the diluent. In an aspect, a cal agitation agent can be a motorized agitation agent. In an 40 Subject can open or break apart the one or more capsule and aspect, an agitation agent or an agitator can be coupled to pour the contents of the opened or broken capsules into the both a motor and the foot bath. Motors and agitators are diluent. known to the art. In an aspect, mechanical agitation can In an aspect, the nystatin can be encapsulated in one or serve to distribute the solution throughout the water con more capsules. In an aspect, the one or more capsules tained within the foot bath. Heating agents and/or means to 45 heat water in a compartment are known to the art. comprising the nyStatin can be added to the diluent. In an In an aspect, the method can comprise adding to the aspect, the one or more capsules can disintegrate and the diluent or to the water an excipient base powder comprising nystatin can be dissolved in the diluent. In an aspect, a a blend of micronized Xylitol and poloxamers. In an aspect, Subject can open or break apart the one or more capsule and the excipient base powder can comprise LoxasperseTM 50 pour the contents of the opened or broken capsules into the excipient base powder. In an aspect, the excipient base diluent. powder can comprise LoxasperseTM excipient base powder In an aspect, a disclosed method can comprise emptying and XyliFosTM excipient base powder. In an aspect, an the water from the foot bath. In an aspect, a disclosed excipient base powder can be obtained from a bulk source. method can comprise cleaning the foot bath. In an aspect, a In an aspect, the mupirocin can be a dry powder. In an 55 disclosed method can comprise drying the foot bath. aspect, the mupirocin can be obtained from a bulk source. The mupirocin can be pure or Substantially pure. In an In an aspect, a disclosed method can treat or prevent an aspect, the mupirocin can be an ointment. In an aspect, the infection affecting the skin of at least a portion of a subjects mupirocin can be a 2% ointment. In an aspect, the mupirocin foot or feet. In an aspect, a disclosed method can treat or can be provided in a tube. For example, in an aspect, the 60 prevent an infection affecting the nail of at least one toe on mupirocin can be provided in a 22 gram tube. In an aspect, a subjects foot or feet. the nystatin can be a dry powder. In an aspect, the nystatin D. Expected Efficacy of Various Anti-Infective Agents can be an ointment. In an aspect, the nyStatin can be obtained from a bulk source. The nystatin can be pure or substantially Table 4 shows the expected efficacy of anti-fungal agents pure. In an aspect, the nystatin can be provided in a 65 against Various fungi. container. For example, in an aspect, the nystatin can be Tables 5 and 6 show the expected efficacy of anti-bacterial provided in 15 gram container. agents against various bacteria. US 9,707,229 B2 107 108 TABLE 4 TABLE 4-continued

EFFICACY OF WARIOUSANTIFUNGALAGENTS EFFICACY OF WARIOUSANTIFUNGALAGENTS Flucon Itracon Voricon- Ampho- Flucon- Itracon- Voricon- Ampho azole azole azole tericin Nystatin 5 azole azole azole tericin Nystatin Aspergiiitisfiavits yes yes yes yes Histoplasma duboisi yes Aspergilius finigatus yes yes yes yes Leishmania donovani yes Aspergilius niger yes yes Leishmania infantum yes Aspergilius terretts yes yes Paracoccidioides yes yes Biastomyces yes yes yes brasiliensis dermatitidis Candida species yes yes yes yes yes Scedosporium yes Coccidioides immitis yes yes yes apiospermain Cryptococci is yes yes yes Sporothrix schenckii yes neoformans Trichophyton yes Fusarium species yes 15 mentagrophytes Histoplasma yes yes Trichophyton rubrum yes capsulatin

TABLE 5

EFFICACY OF WARIOUS ANTIBIOTICAGENTS Gram Bactroban Ceftriaxone Vancomycin Colistimethate Ciprofloxacin

Bacteroides fragilis 88: yes O O O Clostridium difficile 88: O yes O O Clostridium perfingens 88: O yes O Chlamydia pneumoniae na O O O yes Chlamydia psittaci na O O O Chlamydia trachomatis na O O O Mycoplasma pneumoniae na O O O yes Acinetobacter battmannii neg O O O Acinetobacter Caicoaceticits neg O O O Acinetobacter twofi neg O O O Bartonella baciliiformis neg O t O yes Bordeteila pertissis neg O O O O Brucella species neg O O O Campylobacterieitini neg O O O yes Citrobacter diversus neg O yes O yes Citrobacter fieundi neg O yes O yes Enterobacter aerogenes neg O yes O yes yes Enterobacter cloacae neg O yes O yes yes Enterobacter Sakazaki neg O yes O yes Escherichia coi neg O yes O yes yes Franciseia tuiarensis neg O O O yes Haemophilus ducreyi neg O yes O Haemophilus influenzae neg O yes O yes Haemophilus parainfiltenzae neg yes O O yes Kiebsielia neg O yes O yes (Calymmatobacterium) granulomatis Klebsiella Oxytoca neg O yes O yes yes Klebsiella pneumoniae neg O yes O yes yes Legionella pneumophila neg O O O O yes Moraxeia caiarrhais neg O yes O O yes Morganella morgani neg O yes O yes Neisseria gonorrhoeae neg O yes O O yes Neisseria meningitidis neg O yes O O yes Proteus mirabilis neg O yes O O yes Proteus vulgaris neg O yes O O yes Providencia retigeri neg O yes O O yes Providencia Stuarii neg O yes O O yes Pseudomonas aeruginosa neg O O O yes yes Pseudomonas fittorescens neg O O yes yes Rickettsiae neg O O O yes Salmonella typhi neg O yes O yes Serraia marcescens neg O yes O O yes Shigella boydii neg O yes O yes Shigella dysenteriae neg O yes O yes Shigella flexneri neg O yes O yes Shigella sonnei neg O yes O yes Vibrio choierae neg O O O O yes Yersinia pestis neg O O O yes Corynebacterium jeikeium pos O O yes O O Corynebacterium urealyticum pos O O yes O Diphtheroids pos O yes O Enterococci is faecalis pos O yes O US 9,707,229 B2 109 110 TABLE 5-continued

E FFICACY OF WARIOUS ANTIBIOTICAGENTS Gram Bactroban Ceftriaxone Vancomycin Colistimethate Ciprofloxacin

Enterococci is faecium OS O yes, not VRE O O Methicillin resistant staph OS yes O yes O O aureus (MRSA) Peptostreptococcits OS yes yes O Staphylococcusatiretts OS yes yes yes O (MSSA) Staphylococci is epidermidis OS yes yes O yes Streptococci is agaiaciae OS yes yes O Streptococci is pneumoniae OS yes yes O Streptococci is pyogenes OS yes yes yes O Viridans group streptococci OS yes yes O

TABLE 6

EFFICACY OF WARIOUS ANTIBIOTICAGENTS

Sulfa Levofloxacin Tobramycin Doxycycline Azithromycin Clindamycin Trim

Bacteroides fragilis O O O yes O Clostridium difficile O O : O O Clostridium perfingens yes O O yes - partial no Chlamydia pneumoniae yes O yes yes O Chlamydia psittaci O yes yes O O Chlamydia trachomatis O yes yes O O Mycoplasma pneumoniae yese O yes O O Acinetobacter battmannii O O O O Acinetobacter Caicoaceticits O O O Acinetobacter twofi O O O O Bartonella baciliiformis yese yes yes O yes Bordeteila pertissis O yes O yes Brucella species -- yes O O yes Campylobacterieitini yes yes yes yes O O Citrobacter diversus yes yes O O O Citrobacter fieundii yes yes O O O Enterobacter aerogenes yes yes O O yes Enterobacter cloacae yes yes O O yes Enterobacter Sakazakii yes yes O O O Escherichia coi yes yes O O yes Franciseia tuiarensis yes ye S O O O Haemophilus ducreyi yes yes Haemophilus influenzae yes yes yes yes O Haemophilus parainfiltenzae yes yes O O Kiebsiella yes yes O O yes (Calymmatobacterium) Klebsiella Oxytoca yes yes O O yes Klebsiella pneumoniae yes yes : O O yes Legionella pneumophila yes O yes yes O O Moraxeia catarrhais yes yes yes yes O yes Morganella morgani yes O O O yes Neisseria gonorrhoeae yes O O Neisseria meningitidis yes O yes yes O yes Proteus mirabilis yes yes O O O O Proteus vulgaris yes yes O O O O Providencia retigeri yes O O O Providencia Stuarii yes O O O Pseudomonas aeruginosa yes yes O O O O Pseudomonas fittorescens yes yes O O Rickettsiae yes yes yes O O Salmonella typhi yes O Serraia marcescens yes yes l O O O Shigella boydii yes yes O Shigella dysenteriae yes yes O Shigella flexneri yes yes O Shigella sonnei yes yes O Vibrio choierae yes O ye S yes O yes Yersinia pestis yes yes yes O yes Corynebacterium jeikeium O O O Corynebacterium urealyticum O O Diphtheroids O Enterococci is faecalis yes O O O O O Enterococci is faecium O O O O O Methicillin resistant staph O O O O yes US 9,707,229 B2 111 112 TABLE 6-continued

EFFICACY OF WARIOUS ANTIBIOTICAGENTS

Sulfa Levofloxacin Tobramycin Doxycycline Azithromycin Clindamycin Trim aureus (MRSA) Peptostreptococcits O yes yes Staphylococcus aureus (MSSA) yes O yes yes yes Staphylococci is epidermidis yes O yes yes yes yes Streptococci is agaiaciae yes O yes yes yes Streptococci is pneumoniae yes O yes yes yes yes Streptococci is pyogenes yes O yes yes Viridans group streptococci yes O yes yes

15 What is claimed is: 6. The method of claim 1, wherein contacting comprises 1. A method for treating a fungal or bacterial infection of placing at least part of one or both feet of the subject in the a Subjects foot, the method comprising: foot bath for about 10 minutes. (i) mixing mupirocin, itraconazole, and a diluent to form 7. The method of claim 1, comprising repeating steps a solution; (i)-(iv) daily. (ii) adding the Solution to water contained within a foot 8. The method of claim 1, comprise adding to the solution bath; or to the water an excipient base powder. (iii) agitating the water contained within the footbath; and (iv) contacting the agitated water with at least part of one 9. The method of claim 8, wherein the excipient base or both feet of the subject. powder comprises an excipient base powder comprising 2. The method of claim 1, wherein the amount of mupi 25 micronized Xylitol and micronized poloxamers or the excipi rocin comprises about 500 mg and wherein the amount of ent base powder comprises an excipient base powder com the itraconazole comprises about 500 mg. prising micronized Xylitol and micronized poloxamers and 3. The method of claim 1, wherein the ratio of mupirocin an excipient base powder comprising Xylitol, poloxamer to itraconazole comprises about 1:1. 407, hydroxylpropyl betadex, and epigallocatechin gallate. 4. The method of claim 1, wherein the diluent comprises 30 10. The method of claim 1, comprising orally adminis sodium hypochlorite or a solution of sodium hypochlorite. tering to the Subject a pharmaceutical composition compris 5. The method of claim 1, wherein the subject has been ing an anti-bacterial agent, a pharmaceutical composition diagnosed with or is suspected of having an infection that comprising an anti-fungal agent, or both. affects at least part of one or both feet. k k k k k