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

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(12) United States Patent (10) Patent No.: US 9,707,229 B2 Ray, II (45) Date of Patent: *Jul.18, 2017 USOO9707229B2 (12) United States Patent (10) Patent No.: US 9,707,229 B2 Ray, II (45) Date of Patent: *Jul.18, 2017 (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.
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