US 20120074014A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0074014 A1 Tran et al. (43) Pub. Date: Mar. 29, 2012

(54) PRODUCT TYPICALLY BASED ON SALT OF Publication Classi?cation PEROXYMONOSULFURIC ACID AND (51) Int Cl SUITABLE FOR MEDICINAL USAGE, AND A 6} B 29/02 (200601) ASSOCIATED PRODUCT FABRICATION 3231) 19/00 (200601) A61K 33/42 (2006.01) (75) Inventors: David Van Tran, San Jose, CA A61K 9/14 (200601) (Us). David Nguyen Tran San C07C 409/44 (2006.01) Jose ’CA (Us) ’ A61K 31/327 (2006.01) ’ (52) US. Cl...... 206/438; 562/1; 514/578; 424/605; . 424/400; 29/428 (73) Ass1gnee: LuTran Industries, Inc. (57) ABSTRACT (21) App1.No.: 13/047,742 Products based on salt of peroxymonosulfuric acid are suit able for treating or/and preventing diseases and other debili tating medical conditions caused by bacterial, eukaryotic, (22) Filed: Mar. 14, 2011 prion, and viral pathogens and by non-pathogenic in?amma tion. The products may alternatively be based on inorganic Related US. Application Data halide and an oxidizing agent reactable in Water With the inorganic halide to generate hypohalite ions. In addition, the (60) Provisional application No. 61/386,928, ?led on Sep. products can be employed in other applications such as com 27, 2010. mercial and industrial applications.

36 26/ 56 Patent Application Publication Mar. 29, 2012 Sheet 1 0f 2 US 2012/0074014 A1

Fig. 2a Fig. 2b Patent Application Publication Mar. 29, 2012 Sheet 2 0f 2 US 2012/0074014 A1

70 76 72 74 US 2012/0074014 A1 Mar. 29, 2012

PRODUCT TYPICALLY BASED ON SALT OF the antibiotic. The adverse side effects of antibiotics are var PEROXYMONOSULFURIC ACID AND ied, and range from fever and nausea to major allergic reac SUITABLE FOR MEDICINAL USAGE, AND tions. ASSOCIATED PRODUCT FABRICATION [0007] Fungi are eukaryotic pathogens similar to bacteria. Spores are metabolic byproducts of the life cycle of some CROSS-REFERENCE TO RELATED bacteria and fungi. Bacteria produce endospores located APPLICATION Within the cytoplasm of the parental cells. Fungi produce a [0001] This claims priority to US. provisional patent appli variety of exospores. Spores are highly resistant to physical and chemical agents. cation 61/386,928, ?led 27 Sep. 2010, the contents of Which are incorporated by reference to the extent not repeated [0008] In medical parasitology, the term “parasite” means a herein. This is also related to US. patent application Ser. No. eukaryotic pathogenic organism. Hence, protoZoan and meta 12/726,326, ?led 17 Mar. 2009, the contents of Which are Zoan infectious agents are classi?ed as parasites Whereas likeWise incorporated by reference to the extent not repeated bacteria and viruses are not. Many parasites, such as proto herein. Zoa, ?eas, and Worms (helminths), carry disease or cause sores or lesions Which can become infected. FIELD OF USE [0009] Parasites live on or in the host from Which it gets some or all of its nourishment. Parasites are generally harmful [0002] This relates to products suitable for treating and to their hosts. The damage ranges Widely from minor incon preventing debilitating conditions, including debilitating venience to debilitating or fatal disease. An ectoparasite, such medical conditions of humans. This also relates to manufac as a louse, tick, or leech, lives or feeds on the outer surface of turing such products. the host’s body. Ectoparasites do not usually cause disease themselves. HoWever, they are frequently a vector of disease. BACKGROUND OF THE INVENTION For example, tick parasites transmit organisms that can cause [0003] In?ammation is caused by tissue injury consisting disease. An endoparasite lives inside the body of its host. of complex reactions involving vascular and connective tis Endoparasites include organisms such as tapeWorms, hook sues. Tissue damage may result from microbial invasion, Worms, and trypano somes that live Within the ho st’s organs or auto-immune processes, tissue infection, allograft rejection, tissues as Well as organisms such as sporoZoans that invade and such hurtful and/or destructive external in?uences as the host’s cells. heat, cold, radiant energy, electrical or chemical stimuli, and [0010] A prion is an infectious agent generally made solely mechanical trauma. Tissue damage may involve any part of of protein and lacking nucleic acid. Prions are believed to the human body such as the joints (arthritis), boWels (in?am infect and propagate by refolding abnormally into a structure matory boWel disease), and lungs (pulmonary in?ammation). Which converts normal molecules of the protein into an abnor Whatever the cause or bodily site, in?ammatory responses to mally structured form. Prions are generally quite resistant to tissue damage are quite similar, consisting of complicated denaturation by protease, heat, radiation, and formalin treat functional and cellular adjustments involving microcircula ments, although potency or infectivity may be reduced. tion, ?uid shifts, and in?ammatory cells (leukocytes). When [0011] A virus consists of a single nucleic acid, either deox tissue damage occurs, soluble chemical substances are elabo yribonucleic acid (“DNA”) or ribonucleic acid (“RNA”), and rated Which initiate the in?ammatory response. In?ammation a protein shell or coat surrounding the nucleic acid. A com can be mild and self-limited or prolonged and seriously plete viral particle is called a virion. A virus uses the machin debilitating and chronic. ery of a host cell to reproduce and resides Within the host cell. [0004] Numerous drugs have been developed to ?ght Consequently, viruses are di?icult to eliminate Without kill in?ammation in humans. The mo st prominent in current treat ing the host cells. It is believed that viral infections trigger ment are anti-in?ammatory steroidal drugs, corticosteroids in?ammatory responses Which do not respond to anti-viral and non-steroidal anti-in?ammatory drugs such as salicy drugs. Patients often ask for, and physicians often prescribe, lates. While these drugs are generally effective, they often antibiotics. While antibiotics destroy or prevent the groWth of have adverse side effects. bacteria, antibiotics are useless in treating viral (and fungal) [0005] A pathogen is an infectious biological agent, some infections. Their misuse in treating viral diseases is one of the times referred to as a germ, Which causes disease or illness to causes of antibiotic resistance to bacteria. its host. Many medical advances, such as vaccination, antibi [0012] Sporkenbach et al. (“Sporkenbach”), US. Pat. No. otics, and fungicides, have been used to safeguard against 4,404,191, discloses a viricide technique for inactivating infection by pathogens. Nevertheless, pathogens continue to viruses on animate and inanimate surfaces by contacting the threaten human life. Primary pathogens are bacteria, eukary surfaces With a salt of peroxymonosulfuric acid (H2SO5) otes, prions, and viruses. commonly knoWn as Caro’s acid. The peroxymonosulfuric [0006] Bacteria constitute one of the smallest organisms acid salt, applied from an aqueous solution, can be a salt of an containing all the material required for groWth and self-rep alkali metal such as potassium, sodium, or lithium, a salt of an lication. Bacterial infections can be treated With antibiotics, alkaline earth metal such as calcium or magnesium, or an classi?ed as bacteriocidal if they kill bacteria and as bacte ammonium salt. Sporkenbach preferably employs KHSO5 as riostatic if they prevent the bacteria from multiplying so the the peroxymonosulfuric acid salt. KHSO5 is provided from human immune system can overcome them. There are many the mixed triple salt having the chemical formula 2KHSO5. types of antibiotics. Each type of antibiotic inhibits a process KHSO4.K2SO4 Where KHSO4 is potassium hydrogen sulfate Whose pathogen is different from that found in the host. The and K2SO4 is potassium sulfate sometimes referred to as effectiveness of individual antibiotics varies With the location dipotassium sulfate. of the infection, the ability of the antibiotic to reach the site of [0013] KHSO5 and 2KHSO5.KHSO4.K2SO4 each have infection, and the ability of the bacteria to resist or inactivate multiple chemical names. Both KHSO5 and 2KHSO5. US 2012/0074014 A1 Mar. 29, 2012

KHSO4.K2SO4 are commonly referred to as “potassium phosphate, disodium phosphate, trisodium phosphate, tetra monopersulfate”. To avoid confusion, KHSO5 is referred to sodium pyrophosphate, monopotassium phosphate, dipotas herein as “potassium hydrogen peroxymonosulfate” or sim sium phosphate, tripotassium phosphate, and tetrapotassium ply “potassium peroxymonosulfate”. 2KHSO5.KHSO4. pyrophosphate. According to Auchincloss, one embodiment K2SO4 is referred to herein as “potassium monopersulfate of the biocide apparently consisted of 1.5 parts of sodium triple salt” or sometimes simply as “potassium monopersul chloride, 50 parts of potassium monopersulfate triple salt, 10 fate”. parts of sulfamic acid, 5 parts of malic or succinic acid, 18.5 [0014] Sporkenbach identi?es poliovirus, coxsackie virus, parts of sodium hexametaphosphate and (possibly) other simian vacuolating virus 40 and adenovirus as being inacti alkali metal phosphate, and 15 parts of sodium dodecylben vated by potassium hydrogen peroxymonosulfate. Poliovirus Zene sulfonate as the surfactant. causes poliomyelitis. There are tWo forms of coxsackie virus, [0019] Auchincloss reported generally good results in vari type A and type B. Coxsackie A virus causes hand, foot, and ously using its biocide to disinfect chickens, pigs, coWs, and mouth disease, acute haemorrhagic conjunctivitis, herpan horses. Auchincloss also reported that chickens can drink the gina, and aseptic meningitis Which includes viral meningitis. biocide (apparently Without harm), the biocide is not a skin or Coxsackie B virus causes pleurodynia (Bornholm disease) eye irritant, it is possible to bathe in the biocide (likeWise and can induce aseptic meningitis and diabetes mellitus type apparently Without harm), and the biocide can be sprayed in 1. Simian vacuolating virus 40 can cause tumors and cancer. occupied rooms Without causing discomfort. Adenovirus generally produces infections in the upper respi [0020] Potassium peroxymonosulfate triple salt used by ratory tract. Adenovirus infections often appear as gastroen Sporkenbach and Auchincloss is commercially available teritis, conjunctivitis, cystitis, and rash illness. Symptoms of from various sources including E.l. Dupont de Nemours and respiratory illness caused by adenovirus infection include Company under the trade name Oxone and United lnitiators acute viral nasopharyngitis, pneumonia, croup, and bronchi under the trade name Caroat. Potassium hydrogen peroxy tis. monosulfate, the principal component of potassium peroxy [0015] Sporkenbach discloses that its viricide technique monosulfate triple salt, is a strong oxidiZing agent. For can disinfect inanimate surfaces such as Walls, ?oors and instance, potassium hydrogen peroxymonosulfate can con Work surfaces, hospital utensils, and surgical and dental vert halide ions into halogens, ferrous ions into ferric ions, instruments in industrial, domestic, and medical environ manganous ions into manganic ions, and hydrogen peroxide ments and animate surfaces such as the skin of human and into oxygen. Potassium hydrogen peroxymonosulfate can non-human animals during presurgical preparation in human also initiate the free radical polymeriZation of vinyl mono and veterinary medicine. While Sporkenbach’s viricide tech mers such as vinyl acetate, ethyl acrylate, and acrylonitrile. In nique may prevent the diseases caused by the preceding addition to the uses mentioned above, potassium hydrogen viruses from being contracted, Sporkenbach’s technique does peroxymonosulfate serves as a bleaching agent in denture not help already-infected people recover from those diseases. cleansers, toilet-boWl cleaners, and laundry/dry bleaches. [0016] Auchincloss, U.S. Pat. No. 4,822,512, discloses a [0021] Vallieres, U.S. Pat. No. 5,186,946, discloses a dis dry Water-soluble biocide for inactivating certain types of infectant reportedly effective against bacteria, fungi, bacterial viruses, bacteria, and mold on non-human animals, speci? and fungal spores, and viruses. SomeWhat similar to Auchin cally chickens, pigs, coWs, and horses. The biocide contains closs’s composition, Vallieres’ disinfectant consists of 60 to (a) 0.01 to 5 parts by Weight of a Water-soluble inorganic 90 Weight % potassium hydrogen peroxymonosulfate, 2-10 halide, (b) 25 to 60 parts by Weight of an oxidizing agent Weight % malic acid, 2-6 Weight % sulfamic acid, 0.25-3 Which reacts, in aqueous solution, With the halide to generate Weight % ethylene diamine tetraacetic acid disodium salt, and hypohalite ions, (c) 3 to 8 parts by Weight of sulfamic acid, 1-15 Weight % alkylated ether of polyethylene glycol surfac and (d) 10 to 30 parts by Weight of an anhydrous alkali metal tant. Different from Auchincloss, Valliéres avoids the chlo phosphate subject to the total parts totaling 100. The biocide rine present in the sodium chloride preferably used by may include up to 20 parts by Weight of a non-reducing Auchincloss to implement the inorganic halide in Auchin organic acid and up to 20 parts by Weight of an organic closs’s biocide. Vallieres states that its disinfectant is to be surfactant. used for cleaning instruments, ?oors, and bedding in hospi [0017] The preferred oxidizing agent in Auchincloss’s bio tals, bio-medical research centers, health centers, veterinary cide is a persulfate or a peroxyphthalate. A persulfate is a hospitals, and clinics. sulfur-oxygen-containing compound having more oxygen [0022] Potassium hydrogen peroxymonosulfate is also than a normal sulfate. The additional oxygen in a persulfate is used for removing chloramines in sWimming pools. Regard present in the form of one or more peroxide units, a peroxide ing sWimming pools, Lightcap et al. (“Lightcap”), U.S. Pat. being a chemical compound Which includes an oxygen-oxy No. 7,560,033 B2, discloses an anhydrous composition gen single bond. The main types of persulfates are peroxy formed With potassium hydrogen peroxymono sulfate and an monosulfates and peroxydisulfates. A peroxyphthalate is a active halogen agent for sanitiZing Water in recirculating compound having more oxygen than a normal phthalate, the Water systems such as sWimming pools. The active halogen additional oxygen likeWise being present in the form of one or agent consists of an alkali metal salt of dichloro-s-triaZinetri more peroxide units. one or/ and halogenated dimethylhydantoin. Li ghtcap reports [0018] Auchincloss’s oxidiZing agent is normally potas that its composition inhibited the groWth of algae in Water and sium monopersulfate triple salt, i.e., 2KHSO5.KHSO4. inactivated E. coli and Enlerococcus faecium bacteria in K2804. The halide is preferably sodium chloride but can be Water. potassium chloride, potassium bromide, potassium iodide, [0023] Randeri et al. (“Randeri”), U.S. Pat. No. 3,873,696 sodium bromide, or sodium iodide. The organic acid is pref discloses that contact lenses can be effectively cleaned With a erably malic or succinic acid. The alkali metal phosphate can solution containing an oxygen-releasing salt such as a thio be any one of sodium hexametaphosphate, monosodium sulfate, a persulfate, or a peroxydisulfate. Randeri’s preferred US 2012/0074014 A1 Mar. 29, 2012

oxygen-releasing salt is potassium hydrogen peroxymono (Durante”), U.S. Pat. No. 7,442,323 B2. The solvent in the sulfate provided from a triple salt also containing potassium solutions referred to in Tufano and Durante presumably Was hydrogen sulfate (KHSO4) and potassium sulfate (K2804). high-purity Water. Randeri’s solution normally contains a chloride-ion-releas [0028] The loss of active oxygen content of potassium ing salt such as sodium chloride. monopersulfate triple salt composition (KHSOS)X(KHSO4)y [0024] Potassium monopersulfate triple salt of the chemi (K2SO4)Z With time depends on various factors including cal formula 2KHSO5.KHSO4.K2SO4 is an implementation of storage conditions, temperature, and material purity, includ the more general chemical composition (KHSOS)X(KHSO4) ing solution purity for (KHSO5),€(KHSO4)y(K2SO4)Z solu y(K2SO4)Z Where x+y+Z are variable mole (or molar) fractions tions. Regarding solution purity, (KHSO5)x(KHSO4)y (K2SO4)Z solutions made With normal Water have greater loss Whose sum is 1. The general composition (KHSOS),C in oxygen content With time than (KHSO5)x(KHSO4)y (KHSO4)y(K2SO4)Z is referred to herein as “potassium (K2SO4)Z solutions made With high-purity Water because nor monopersulfate triple salt composition” Where the Word mal Water contains a considerably higher content of metals “composition” distinguishes (KHSO5),€(KHSO4)y(K2SO4)Z than catalyZe (promote) the decomposition of potassium from the speci?c formulation 2KHSO5.KHSO4.K2SO4. hydrogen peroxymonosulfate (KHSOS). In any event, the loss When mole fractions x, y, and Z respectively are 0.5, 0.25, and in active oxygen content signi?cantly reduces the potency of 0.25, the potassium monopersulfate triple salt composition potassium monopersulfate triple salt composition (KHSOS),C (KHSO5)x(KHSO4)y(K2SO4)Z becomes potassium monoper (KHSO4)y(K2SO4)Z, especially in solution form. sulfate triple salt of the formula 2KHSO5.KHSO4.K2SO4. [0029] Potassium peroxymonosulfate triple salt composi [0025] A molecule of potassium hydrogen peroxymono tion (KHSO5),€(KHSO4)y(K2SO4)Z, including potassium per sulfate (KHSO5) functions as an oxidizer by decomposing oxymonosulfate triple salt 2KHSO5.KHSO4.K2SO4 itself, and “releasing” one of its oxygen atoms. The oxygen Which can be manufactured in various Ways. Martin, U.S. Pat. No. can be so released from potassium hydrogen peroxymono 7,090,820 B2, discloses a technique for manufacturing the sulfate is generally referred to as “active oxygen”. Pure potas potassium monopersulfate triple salt composition (KHSOS),C sium hydrogen peroxymonosulfate has an active oxygen con (KHSO4)y(K2SO4)Z With mole fractions x, y, and Z adjusted to tent of approximately 10.5%. achieve an active oxygen content greater than 4.5% and With a reduced content of potassium persulfate. In a ?rst embodi [0026] The Weight (mass) fractions of potassium hydrogen ment, x is 0.43-0.64, y is 0.15-0.43, and Z is 015-043. In a peroxymonosulfate (KHSOS), potassium hydrogen sulfate second embodiment, x is 0.46-0.64, y is 015-037, and Z is (KHSO4), and potassium sulfate (K2SO4) respectively are 0.1 5-0.37. roughly 45%, 25%, and 30% in a common formulation of [0030] Martin’s process for manufacturing the potassium potassium monopersulfate triple salt composition (KHSOS),C triple salt composition so that mole fractions x, y, and Z fall (KHSO4)y(K2SO4)Z. This formulation has an active oxygen into the ranges of the second embodiment entails adding a content of approximately 4.7%. The active oxygen content of hydrogen peroxide solution containing at least 70% hydrogen potassium monopersulfate triple salt composition (KHSOS),C peroxide by Weight to a sulfuric acid solution containing at (KHSO4)y(K2SO4)Z, such as this formulation, is loWer than least 90% sulfuric acid by Weight at a sulfuric-acid-to-hydro the active oxygen content of potassium hydrogen peroxy gen-peroxide ratio Which is substoichiometric to produce a monosulfate (KHSOS) itself due to the presence of non-oxi ?rst Caro’s acid solution containing peroxymonosulfuric acid diZing components potassium hydrogen sulfate (KHSO4) and (again, H2805) and hydrogen peroxide. The ?rst Caro’s acid potassium sulfate (K2SO4) in potassium monopersulfate solution is combined With oleum containing sulfuric acid and triple salt composition. A small percentage of potassium per sulfur trioxide. The oleum reacts With Water in the ?rst Caro’s sulfate (or potassium perdisulfate) of the chemical formula acid solution to produce a second Caro’s acid solution. An K28208 may be present in potassium peroxymonosulfate alkali potassium compound is added to the second Caro’s acid triple salt composition and in the speci?c potassium peroxy solution to produce a partially neutraliZed solution containing monosulfate triple salt. The potassium persulfate is generally potassium monopersulfate triple salt composition (KHSOS),C undesirable because it reduces the active oxygen content, for (KHSO4)y(K2SO4)Z in Which x, y, and Z have values in the example, to 4.5%. A higher active oxygen content is often ranges of Martin’s second embodiment. desired. [0031] Looking noW at the background art in total, bacte [0027] The active oxygen content of potassium monoper rial, eukaryotic, prions, and viral pathogens cause many dis sulfate triple salt composition (KHSO5),€(KHSO4)y(K2SO4)Z eases to human. Success in treating these diseases varies decreases With time due to the decomposition of the potas Widely. While treatments for some of these diseases are essen sium hydrogen peroxymonosulfate (KHSOS) and the atten tially fully successful, treatments for others are only partially dant release of some of the active oxygen. The decrease of successful or do not currently exist. In particular, treatments active oxygen content With time is considerably greater for for allergic rhinitis, arthritis, bronchitis, hemorrhoids, urti solutions containing potassium monopersulfate triple salt caria, toothache, tinea pedis, acute viral nasopharyngitis, her composition (KHSO5),€(KHSO4)y(K2SO4)Z than for dry solid pes simplex, dandruff, itching, bromhidrosis, and vaginitis potassium monopersulfate triple salt composition (KHSOS),C are commonly Weak or non-existent. Even When treatments (KHSO4)y(K2SO4)Z. In particular, anhydrous solid potassium are fully or partially successful, there are often adverse side monopersulfate triple salt 2KHSO5.KHSO4.K2SO4 loses effects to the treatments. roughly 1% of its active oxygen content per month as reported [0032] Sporkenbach’s technique of using a peroxymono in Tufano et al. (“Tufano), U.S. Pat. No. 6,818,142 B2. HoW sulfuric acid salt, preferably potassium hydrogen peroxy ever, solutions of potassium monopersulfate triple salt monosulfate, to inactivate certain viruses on animate and 2KHSO5.KHSO4.K2SO4 lose 3-5% of their active oxygen inanimate surfaces is an advancement. HoWever, Sporken content per month as indicated in Tufano and Durante et al. bach’s viricidal technique is not useful in treating people to US 2012/0074014 A1 Mar. 29, 2012

recover from the diseases caused by those viruses. It is desir composition, the active material includes salt of peroxy able to have better techniques and medicinal products for monosulfuric acid or/ and reaction product of the salt of per treating people infected With diseases caused by bacterial, oxymonosulfuric acid and other material of the composition. eukaryotic, prions, and viral pathogens and by non-patho The salt of peroxymonosulfuric acid is again typically prima genic in?ammation. rily potassium hydrogen peroxymonosulfate. In another implementation of the semiliquid composition, the active GENERAL DISCLOSURE OF THE INVENTION material includes (a) inorganic halide or/ and reaction product [0033] The present invention furnishes advanced products of the inorganic halide and other material of the composition and (b) an oxidiZing agent or/and reaction product of the suitable for treating diseases and other debilitating medical conditions caused by bacterial, eukaryotic, prion, and viral oxidiZing agent and other material of the composition. The pathogens, including fungal, spore, and parasitic pathogens, oxidiZing agent is again reactable in Water With the inorganic and by non-pathogenic in?ammation. The products provided halide to generate hypohalite ions. by the invention are also suitable for preventing debilitating [0039] The semiliquid composition in the ?rst aspect of the medical conditions caused by bacterial, eukaryotic, prion, invention normally has a dynamic viscosity of at least 5 Pa-s and viral pathogens and by non-pathogenic in?ammation. In at 25° C. The dynamic viscosity of the composition is nor addition, the products provided by the invention can be used mally no more than 5,000 Pa-s at 25° C. By providing the in other applications such as commercial and industrial appli composition in semiliquid form, particularly With a dynamic cations. viscosity of 5 to 5,000 Pa-s at 25° C., the shelf life of the [0034] More speci?cally, a product in a ?rst aspect of the composition is expected to be extended While simultaneously invention is a disintegrable composition for introduction into enabling the composition to be readily administered. a liquid, normally Water. The composition, normally consist [0040] A product in a third aspect of the invention is a ing of solid material, is of such a structure that the composi container assembly consisting at least partially of a compo tion gradually disintegrates upon introduction into the liquid sition and a container that holds the composition. The com for enabling particles of the composition to disperse into the ponents of the composition, normally a liquid, include a car liquid so that the mass of the composition is 10% to 90% of rier and active material dispersed largely throughout the the initial mass value 1 hour to 100 days after the composition carrier. In one implementation of the container assembly, the is introduced into the liquid. The gradual disintegration of the active material includes salt of peroxymonosulfuric acid composition is generally referred to as metered release. or/and reaction product of the salt of peroxymonosulfuric [0035] The disintegrable composition contains active acid and other material of the composition. The salt of per material Which is mainly responsible for the composition’s oxymonosulfuric acid is once again typically primarily potas advantageous properties. In one implementation of the disin sium hydrogen peroxymonosulfate. In another implementa tegrable composition, the active material includes salt of per tion of the container assembly, the active material includes (a) oxymonosulfuric acid, typically primarily potassium hydro inorganic halide or/and reaction product of the inorganic gen peroxymonosulfate. In another implementation of the halide and other material of the composition and (b) an oxi disintegrable composition, the active material includes inor diZing agent or/and reaction product of the oxidiZing agent ganic halide and an oxidizing agent reactable in Water With and other material of the composition. The oxidiZing agent is the inorganic halide to generate hypohalite ions. once again reactable in Water With the inorganic halide to [0036] The rate of disintegration can be adjusted to accom generate hypohalite ions. modate various situations. Relatively fast metered release of [0041] The container blocks transmission of visible light, the disintegrable composition is, for example, useful in situ and typically also other radiation such as ultraviolet (“UV”) ations Where a person ingests a piece of the disintegrable radiation, incident on the container from outside the container composition to treat a debilitating medical condition. The in one embodiment of the product in the third aspect of the piece of the disintegrable composition then disintegrates in invention. This prevents visible light, and typically also such liquid, normally Water, in the person’s body so that the result other radiation, from degrading the composition, thereby ant liquid composition is administered internally to the per enabling it to have extended shelf life at suitably highpotency. son in a gradual manner. In another embodiment of this product, the composition is [0037] Relatively sloW metered release of the disintegrable subjected to an average pressure of more than 1 atm, prefer composition is useful in situations in Which the potency of the ably at least 2 atm, inside the container. The elevated pressure liquid form of the composition needs to be maintained suit inside the container assists in dispensing the product from the ably high for an extended period. A manufacturer of the liquid container While preventing material, such as air, outside the composition can employ sloW metered release of the disinte container from contaminating the composition and causing it grable composition to provide the liquid composition With to degrade. The shelf life at suitably high potency is again extended shelf life at suitably high potency. A user of the extended. liquid composition can utiliZe sloW metered release of the [0042] The product in the third aspect of the invention disintegrable composition for maintaining the potency of the normally includes a dispenser hermetically attached to the liquid composition suitably high for an extended period sub container for controllably dispensing the composition from sequent to combining the disintegrable composition With the the container. In a further embodiment of the product, the liquid. Additionally, by providing the disintegrable composi dispenser prevents material outside the container and the tion as solid material, the disintegrable composition itself has dispenser from entering the container through the dispenser. a long shelf life. This similarly extends the shelf life by preventing material, [0038] A product in a second aspect of the invention is a such as air, outside the container from contaminating the composition formed With a carrier and active material dis composition and causing it to degrade. The features of these persed largely throughout the carrier such that the composi three embodiments may be variously combined in other tion is semiliquid. In one implementation of the semiliquid embodiments of this product. US 2012/0074014 A1 Mar. 29, 2012

[0043] A product in a fourth aspect of the invention is a persed largely throughout the carrier, and an inhibitor dis multiple-container assembly consisting at least partially of a persed largely throughout the carrier. The active material ?rst container, a second container, and a combining element includes an oxidizing agent or/and reaction product of the attached to or integral With at least one of the containers. The oxidizing agent and other material of the composition. The ?rst container contains a liquid carrier. The second container oxidizing agent contains active oxygen that consists of contains a primary composition containing active material. chemically readily transferable oxygen atoms. The inhibitor The combining element enables matter of the primary com inhibits the composition from losing active oxygen. As a position and matter of the carrier to be combined to form a result, the potency of the inhibitor-containing composition is further composition. maintained at a suitably high level for extended time so that [0044] The active material includes salt ofperoxymonosul the composition has increased shelf life. furic acid, again typically primarily potassium hydrogen per [0052] The oxidizing agent in one implementation of the oxymonosulfate, in one implementation of the double-con inhibitor-containing composition is salt of peroxymonosul tainer assembly. In another implementation of the multiple furic acid, normally primarily potassium hydrogen peroxy container assembly, the active material includes inorganic mono sulfate. In another implementation of the inhibitor-con halide and an oxidizing agent reactable in Water With the taining composition, the active material includes inorganic inorganic halide to generate hypohalite ions. halide in addition to the oxidizing agent. With the liquid [0045] All the material of the primary composition is nor carrier including Water in this implementation, the oxidizing mally solid material. The further liquid composition created agent is reactable in Water With the inorganic halide to gen by combining matter of the primary composition and matter erate hypohalite ions. of the carrier need not be formed until shortly before the [0053] In short, the invention furnishes a variety of prod further liquid composition is administered to a person. As a ucts having extended shelf life. The products of the invention result, the multiple-container assembly has a long shelf life. are suitable for treating diseases and other debilitating medi [0046] A product in a ?fth aspect of the invention is a cal conditions caused by bacterial, eukaryotic, prion, and composition containing a plurality of solid particles consist viral pathogens, including fungal, spore, and parasitic patho ing of support material and active material. Because the par gens, and by non-pathogenic in?ammation and for preventing ticles are solid, the particle-containing composition has a long debilitating medical conditions caused by bacterial, eukary shelf life. otic, prion, and viral pathogens and by non-pathogenic [0047] The active material includes salt of peroxymonosul in?ammation. The products of the invention can also be used furic acid, once again typically primarily potassium hydrogen in other applications. The invention thereby provides a large peroxymonosulfate, in one implementation of the particle advance over the prior art. containing composition. The salt of peroxymonosulfuric acid is present in the particles at an average mass percentage of no BRIEF DESCRIPTION OF THE DRAWINGS more than 10%. The support material is normally non-reac [0054] FIG. 1 is a side cross-sectional vieW of a container tive With the salt of peroxymonosulfuric acid and With reac assembly in accordance With the invention for dispensing a tion product of the salt of peroxymonosulfuric acid and any medicinal drug. other material of the composition When it is dry or combined [0055] FIGS. 2a and 2b are side cross-sectional vieWs of a With Water. typical embodiment of the dispenser in the container assem [0048] In another implementation of the particle-contain bly of FIG. 1 respectively in the non-actuated and actuated ing composition, the active material includes inorganic halide conditions. and an oxidizing agent reactable in Water With the inorganic halide to generate hypohalite ions. The oxidizing agent is [0056] FIG. 3 is a side cross-sectional/schematic vieW of a double-container assembly in accordance With the invention present in the particles at an average mass percentage of no for dispensing a medicinal drug. more than 10%. The support material is normally non-reac tive With the oxidizing agent and With reaction product of the [0057] FIG. 4 is a side cross-sectional vieW ofa poWder of oxidizing agent and any other material of the composition particles that contain a medicinal drug in accordance With the invention. When it is dry or combined With Water. [0058] Like reference symbols are used in the draWings and [0049] The particles containing either implementation of in the description of the preferred embodiments to represent the particle-containing composition are normally so small that they form a poWder. In particular, the average diameter of the same, or very similar, item or items. the particles is normally no more than 500 pm. DESCRIPTION OF THE PREFERRED [0050] A further composition is formed by combining the particles containing either implementation of the particle EMBODIMENTS containing composition With a liquid carrier, normally Water. [0059] Persons af?icted With diseases and other debilitat The liquid carrier promotes chemical reactions involving the ing medical conditions caused by bacterial, eukaryotic, prion, active material. HoWever, the particle support material and and viral pathogens, including fungal, spore-caused, and the liquid carrier can readily be chosen so that the support parasitic infections, and by non-pathogenic-caused in?am material is chemically non-reactive in the presence of the mation are treated With a medicinal drug formed at least carrier. As a result, comparatively feWer chemical reactions partially With salt, i.e., one or more individual salts, of per involving the active material are expected to occur. This, in oxymonosulfuric acid (HZSOS). Such a salt is generally turn, is expected to enable the further composition to have referred to as a peroxymonosulfate. The medicinal drug suitably high potency for increased time subsequent to com formed at least partially With peroxymonosulfate is referred bining the particles With the liquid carrier. to herein as being of type I. The medicinal drug of type I can [0051] A product in a sixth aspect of the invention is a also be administered to persons for preventing them from composition containing a liquid carrier, active material dis contracting debilitating medical conditions caused by bacte US 2012/0074014 A1 Mar. 29, 2012

rial, eukaryotic, prion, and viral pathogens, including fungal, cesium hydrogen peroxymonosulfate may respectively be spore-caused, and parasitic infections, and by non-patho referred to simply as rubidium peroxymonosulfate and genic-caused in?ammation. cesium peroxymonosulfate. [0060] Peroxymonosulfates are generally strong oxidizing [0065] The alkaline earth metal salts of peroxymonosulfu agents, i.e., they readily provide (or release) oxygen under ric acid consist of its alkaline earth metal salts and its alkaline certain conditions at standard temperature (20-250 C.) and earth metal hydrogen salts. For primary alkaline earth metals standard pressure (760 torr). In particular, oxygen is readily magnesium and calcium, the alkaline earth metal salts of released by a peroxymono sulfate When it is present in Water, peroxymono sulfuric acid are magnesium peroxymono sulfate typically in aqueous solution. The active oxygen content RA0, (MgSOS), magnesium dihydrogen diperoxymonosulfate i.e., fraction or percentage of readily providable oxygen, of an oxidiZing agent such as a peroxymonosulfate is given gener (MgH2(SO5)2), calcium peroxymonosulfate (CaSOS), and ally as: calcium dihydrogen diperoxymonosulfate (CaH2(SO5)2). [0066] Beryllium, barium, and strontium are additional alkaline earth metals. To the extent manufacturable Without Where mAO is the mass of the active oxygen in the oxidiZing being toxic, the alkaline earth metal salts of peroxymonosul agent, mOXAG is the mass of the oxidiZing agent, W0 is the furic acid further include beryllium peroxymonosulfate molecular Weight of oxygen, N is the number of moles of (BeSOS), beryllium dihydrogen diperoxymonosulfate (BeH2 active oxygen in a mole of the oxidiZing agent, and WOXAG is (SO5)2), barium peroxymonosulfate (BaSOS), barium dihy the molecular Weight of the oxidiZing agent. drogen diperoxymonosulfate (BaH2(SO5)2), strontium per [0061] Oxygen’s molecular Weight W0 is approximately oxymonosulfate (SrSOS), and strontium dihydrogen 16.00. Accordingly, active oxygen content RA0 is more par diperoxymonosulfate (SrH2(SO5)2). ticularly given as: [0067] An ammonium salt of peroxymonosulfuric acid is chemically representable as NRaRbReRdHSO5 or as NRaR RAO=16.00 N/WOMG (2) bRCRdNRERfRgRhSOS Where each of Ra, Rb, RC, Rd, Re, Rf, The oxidiZing capability of the peroxymonosulfate used in Rg, and Rh is variously hydrogen or a hydrocarbon group such forming the medicinal drug of type I is believed to be a factor as an alkyl, cycloalkyl, aryl, or aralkyl group. For the NRaR in the drug’s effectiveness in combating bacterial, eukaryotic, bRCRdNRERfRgRhSOS ammonium peroxymonosulfates, Re, prion, and viral pathogens that attack humans and in causing Rf, R8, and Rh are typically respectively the same as Ra, Rb, non-pathogenic-caused in?ammation to be reduced in RC, and R d. The non-carbon ammonium salts of peroxymono humans. Eq. 2 thus provides an estimate of the oxidiZing sulfuric acid are ammonium hydrogen peroxymonosulfate capability of the peroxymonosulfate used in forming the drug (NH4HSO5) and diammonium peroxymonosulfate ((NH4)2 of type I. SOS). Ammonium hydrogen peroxymonosulfate may be [0062] The peroxymonosulfates include alkali metal salts, referred to simply as ammonium peroxymonosulfate. alkaline earth metal salts, and ammonium (group) salts of [0068] Peroxymonosulfuric acid may also form salts With peroxymonosulfuric acid. Such a peroxymonosulfate is metals in parts of the Periodic Table other than the alkali chemically representable as Ml-Hj(SO5)k Where M is an alkali metals of Group 1a and the alkaline earth metals of Group lb. metal in Group 1a of the Periodic Table, an alkaline earth For instance, peroxymonosulfuric acid may form salts With metal in Group lb of the Periodic Table, or an ammonium metals, e.g., Zinc, in Group 2b of the Periodic Table. To the group and Where i, j, and k are integers. Integers i, j, and k extent manufacturable, the Group 2b salts of peroxymono satisfy the relationship ni+j equals 2k Where n is an integer sulfuric acid include Zinc peroxymonosulfate (ZnSO5) and equal to 1 for an alkali metal or an ammonium group and Zinc dihydrogen diperoxymonosulfate (ZnH2(SO5)2). equal to 2 for an alkaline earth metal. Integer j can be 0 such [0069] The salt of peroxymonosulfuric acid used in form that hydrogen is absent in the H]. term of MiHj(SO5)k. ing the medicinal drug of type I is preferably potassium [0063] The alkali metal salts of peroxymonosulfuric acid hydrogen peroxymonosulfate (KHSOS). In a molecule of consist of its alkali metal hydrogen salts and its dialkali metal potassium hydrogen peroxymonosulfate, a pair of oxygen salts. For primary alkali metals lithium, sodium, and potas atoms singly bonded to each other are situated betWeen the sium, the alkali metal salts of peroxymonosulfuric acid are sulfur and hydrogen atoms. The single oxygen-oxygen bond lithium hydrogen peroxymonosulfate (LiHSOS), dilithium readily breaks under certain conditions, e.g., When the mol peroxymonosulfate (LiZSOS), sodium hydrogen peroxy ecule of potassium hydrogen peroxymonosulfate is dissolved monosulfate (NaHSOS), disodium peroxymonosulfate in a suitable solvent such as Water, to release one of the (NaZSOS), potassium hydrogen peroxymonosulfate oxygen atoms involved in the single oxygen-oxygen bond. (KHSOS), and dipotassium peroxymonosulfate (K2805). The molecular Weight WKHSO5 of potassium hydrogen per Similar to potassium hydrogen peroxymonosulfate often oxymonosulfate is approximately 152.17. Potassium hydro referred to as potassium peroxymonosulfate, lithium hydro gen peroxymonosulfate has one mole of active oxygen per gen peroxymonosulfate and sodium hydrogen peroxymono mole of potassium hydrogen peroxymonosulfate. Utilizing sulfate may respectively be referred to simply as lithium Eq. 2 given above, active oxygen content RA0 of pure potas peroxymonosulfate and sodium peroxymonosulfate. sium hydrogen peroxymonosulfate is approximately 10.5%. [0064] Rubidium and cesium are additional alkali metals. [0070] The potassium hydrogen peroxymonosulfate used To the extent manufacturable Without being toxic, the alkali in forming the medicinal drug of type I is normally provided metal salts of peroxymonosulfuric acid further include as a component of a multiple salt, preferably potassium rubidium hydrogen peroxymonosulfate (RbHSOS), diru monopersulfate triple salt composition (KHSOS)X(KHSO4)y bidium peroxymonosulfate (Rb2SO5), cesium hydrogen per (K2SO4)Z for Which the sum of mole fractions x, y, and Z oxymonosulfate (CsHSOS), and dicesium peroxymonosul equals 1. Potassium hydrogen sulfate (KHSO4) and potas fate (CsZSOS). Rubidium hydrogen peroxymonosulfate and sium sulfate (K2804), again sometimes referred to as dipo US 2012/0074014 A1 Mar. 29, 2012

tassium sulfate, are physically bonded to potassium hydrogen [0074] The active oxygen content RA0, i.e., fraction or per peroxymonosulfate in potassium monopersulfate triple salt centage of active oxygen, in potassium monopersulfate triple composition. salt composition is given in terms of mole fractions x, y, and [0071] Neither potassium hydrogen sulfate nor potassium Z by the relationship: sulfate readily releases oxygen under the same conditions at RAO = WOX/ (WKHSOSX + 14/104304)’ + WK2s04Z) (7) standard temperature and pressure for Which potassium hydrogen peroxymonosulfate readily releases oxygen. The overall oxidiZing agent formed With potassium monopersul ::16.00x/(152.17x + 136.17y + 174.261) fate triple salt composition normally used in forming the medicinal drug of type 1 thereby consists of (a) active oxygen Where W0 is again the molecular Weight of oxygen. For the releasing material formed by potassium hydrogen peroxy preceding formulation in Which mole fractions x, y, and Z monosulfate and (b) other material, referred to here as inac respectively are 0.5, 0.25, and 0.25, active oxygen content tive material, consisting of potassium hydrogen sulfate and RA0 is approximately 5.2%. potassium sulfate. [0075] The mole fraction FMP of component CP in a general [0072] The mass fraction FMP of a component CP of a gen product is, in turn, given as: eral product having n components Cl, . . . Cq, . . . C”, each Fm ” Fm (8) being of a molecular Weight Wq and of a mole fraction PM, in the product, is given as: Mel/Q75] Accordingly, mole fractions x, y, and Z respectively of potas ” (3) sium hydrogen peroxymono sulfate, potassium hydrogen sul Fmp = WpFMp / Z WqFMq fate, and potassium sulfate in potassium monopersulfate q:l triple salt composition (KHSO5),€(KHSO4)y(K2SO4)Z are respectively given in terms of mass fractions FMIQSOS, Where q is an integer varying from 1 to n and Where the sum of mole fractions FM], . . . FMq, . . . FM” equals 1. The molecular Weights WIQSOS, WKHSO4, and WIQSO4 of potas x : (FmKHSOSWKHSOS )/(FmKHSOSWKHSOS FmKHS04WKHSO4 FmK2SO4)WK2S04 (9) sium hydrogen peroxymonosulfate, potassium hydrogen sul 2: + + fate, and potassium sulfate respectively are 152.17, 136.17, (FmKHSOS)/(FmKHSOS152.17 152.17 FmKHS04136.17 FmK2SO4)174.26 and 174.26 (to tWo signi?cant digits beyond the decimal point). Letting FMIQSOS, FMKHSO4, and FMK2SO4 represent the _ (FmKHSO4) /(FmKHSOS FmKHS04 FmK2SO4) (10) respective mass fractions of potassium hydrogen peroxy WKHSO4 WKHSOS WKHSO4 WK2S04 monosulfate, potassium hydrogen sulfate, and potassium sul 7~ (FmKHSO4136.17 ) /(FmKHSOS152.17 FmKHS04136.17 FmK2SO4)174.26 fate in potassium monopersulfate triple salt composition (KHSO5)x(KHSO4)y(K2SO4 Z, mass fractions FMIQSOS, Z _ (FmK2S04)/(FmKHS0S FmKHSO4 FmK2SO4) (11) FMKHSO4, and FMK2SO4 are respectively given in terms of mole WK2S04 WKHSOS WKHS04 WK2S04 fraction x of potassium hydrogen peroxymonosulfate, mole ~ (FmK2SO4) /(FmKHSOS FmKHSO4 FmK2SO4) fraction y of potassium hydrogen sulfate, and mole fraction Z 7 174.26 152.17 136.17 174.26 of potassium sulfate as: [0076] Mass fractions FMKHSOS, FMKHSO4, and FMK2SO4 respectively are approximately 45%, 25%, and 30% in another formulation of potassium monopersulfate triple salt FmKHSOS = WKHSOSX/ (WKHSOSX + 14/104304)’ + WK2s04Z) (4) composition used in forming the medicinal drug of type I. Use z 152.17X/(152.17X +136.17y + 174.261) of Eqs. 9-11 yields the folloWing values for mole fractions x, FmKHSO4 = WKHs04X/ (WKHSOSX + 14/104304)’ + WK2s04Z) (5) y, and Z in this second formulation: (a) mole fraction x of z 136.17X/(152.17X +136.17y + 174.261) potassium hydrogen peroxymonosulfate is approximately 46%, (b) mole fraction y of potassium hydrogen sulfate is approximately 28%, and (c) mole fraction y of potassium sulfate is approximately 26%. The second formulation of the potassium monopersulfate triple salt composition is then [0073] Potassium monopersulfate triple salt composition is approximately given as (KHSO5)O_46(KHSO4)O_28(K2SO4)O_ 26 or approximately equivalently as 1.7KHSO5.1.1KHSO4. implemented With potassium monopersulfate triple salt K2804. (2KHSO5.KHSO4.K2SO4) in one formulation used in form ing the medicinal drug of type I. Inasmuch as mole fractions [0077] Active oxygen content RA0 is given in terms of mass x, y, and Z respectively are 0.5, 0.25, and 0.25 in this formu fraction FMIGISO5 as: lation, use of Eqs. 4-6 yields the folloWing values for mass fractions FMIQSOS, FMKHSO4, and FMK2SO4 in this formulation: (a) mass fraction FMKZSO5 of potassium hydrogen peroxy RAO = (W0 / WKHSOS)FKHSOS (12) monosulfate is approximately 50%, (b) mass fraction z (16.00/152.17)FKHS0S FMKHSO4 of potassium hydrogen sulfate is approximately 22%, and (c) mass fraction FMK2SO4 of potassium sulfate is z 0.1051120.”5 approximately 28%. US 2012/0074014 A1 Mar. 29, 2012

For the second formulation of potassium monopersulfate tion containing potassium monopersulfate triple salt compo triple salt composition in Which mass fraction FWKHSO5 is sition (KHSO5)x(KHSO4)y(K2SO4)Z. The partially neutral approximately 45%, active oxygen content RA0 is approxi iZed solution is concentrated to form a slurry of the potassium mately 4.7%. monopersulfate triple salt composition at a desired speci?c [0078] The medicinal drug of Type I may be formed With a gravity, e.g., 1.55-1.65. The slurry is typically formed by small percentage, normally no more than a feW percent by mixing in a vacuum evaporator at a temperature of no more mass, typically no more than 1% by mass, of one or more than 35° C. The slurry is separated into mother liquor and other potassium-sulfur-oxygen salts, such as potassium per solids of Which the solids contain the monopersulfate triple sulfate (K2S2O8), present as impurity in the potassium salt composition. The solids are dried at a temperature of no monopersulfate triple salt composition. Although this might more than 90° C., preferably no more than 70° C. Further cause the resultant composition of potassium hydrogen per details on this process are presented in Martin, the contents of oxymonosulfate, potassium hydrogen sulfate, potassium sul Which are incorporated by reference herein. fate, and each other potassium-sulfur-oxygen salt to strictly [0083] By suitably controlling the process conditions, mole be a multiple salt of at least four potassium-sulfur-oxygen fractions x, y, and Z of the potassium monopersulfate triple salts, the resultant composition is substantially potassium salt composition (KHSO5),€(KHSO4)y(K2SO4)Z fall into the monopersulfate triple salt composition because the impurity folloWing ranges. Broadly, x is 0.43-0.64, y is 015-043, and potassium-sulfur-oxygen salt constitutes only a small per Z is 0.15-0.43. More narroWly, x is 0.46-0.64, y is 015-037, centage by mass of the resultant composition. Furthermore, and Z is 015-037. the potassium hydrogen peroxymonosulfate, potassium [0084] The speci?c values of mole fractions x, y, and Z hydrogen sulfate, and potassium sulfate used in forming the Within the preceding ranges are often selected so that active resultant composition still constitute potassium monopersul oxygen content RA0 of the resultant formulation of the potas fate triple salt composition. sium monopersulfate triple salt composition is greater than [0079] The medicinal drug of type I may be formed With the approximate 4.7% active oxygen content of the second one or more components in addition to salt of peroxymono formulation of potassium monopersulfate triple salt compo sulfuric acid and, When the salt of peroxymonosulfuric acid sition in Which mass fraction FWKHSO5 of potassium hydrogen consists of potassium hydrogen peroxymonosulfate provided peroxymonosulfate is approximately 45% and in Which cor as a component of potassium monopersulfate triple salt com responding mole fraction x of potassium hydrogen peroxy position, one or more components in addition to potassium monosulfate is approximately 46%. For instance, mole frac hydrogen sulfate, potassium sulfate, and any impurity in the tions x, y, and Z are typically chosen active oxygen content potassium monopersulfate triple salt composition. The com RA0 of the formulation of the potassium monopersulfate ponents used to form the drug of type I are preferably all Water triple salt composition is greater than 4.9%. At the same time, soluble such that the drug of type I is Water soluble. The drug the amount of potassium persulfate in the formulation of the of type I is, as discussed further beloW, typically provided in potassium monopersulfate triple salt composition is less than a therapeutically inactive pharmaceutically acceptable car 0.5% by mass. rier, often Water in Which the components used to form the [0085] Increasing mole fraction x of potassium hydrogen drug are dissolved. One or more of the components used to peroxymonosulfate in potassium monopersulfate triple salt form the drug of type I may, nonetheless, be non-soluble in composition (KHSO5),€(KHSO4)y(K2SO4)Z generally causes Water. In that case, each non-Water-soluble component is active oxygen content RA0 to increase. For example, an RA0 normally in liquid form or colloidably suspendable in Water. value of 5.2%, and thus greater than 4.7%, is achieved With [0080] Formulations of potassium peroxymonosulfate the ?rst-mentioned formulation in Which mole fractions x, y, triple salt composition suitable for use in forming the medici and Z respectively are 0.5, 0.25, and 0.25. Active oxygen nal drug of type I can be manufactured in various Ways. It is content RA0 of potassium monopersulfate triple salt compo typically desirable that a (KHSO5)x(KHSO4)y(K2SO4)Z for sition can be made greater than 6% by choosing mole fraction mulation used in forming the drug of type I have a higher x of potassium hydrogen peroxymonosulfate to be at, or close active oxygen content, and a loWer potassium persulfate to, the upper limit of 0.64 in the tWo sets of mole fraction impurity content, than the second formulation of potassium ranges given above. As another example, use of Eq. 7 yields monopersulfate triple salt composition in Which mass frac an RA0 value of approximately 6.7% When mole fraction x is tion FWKHSO5 is approximately 45%. 0.64 and mole fractions y and Z both are 0.18. [0081] With reference to Martin, cited above, a suitable [0086] As described in Martin, the foregoing process can be process for manufacturing the potassium triple salt composi modi?ed in various Ways. For instance, a suprastoichiometric tion entails ?rst adding a hydrogen peroxide (H202) solution sulfuric-acid-to-hydrogen-peroxide ratio can be used instead containing at least 70% hydrogen peroxide by mass to a of a substoichiometric sulfuric-acid-to-hydrogen-peroxide sulfuric acid (H2SO4) solution containing at least 90% sulfu ratio. In that case, mole fractions x, y, and Z of the potassium ric acid by mass at a substoichiometric sulfuric-acid-to-hy monopersulfate triple salt composition (KHSOS)X(KHSO4)y drogen-peroxide ratio to produce a ?rst Caro’s acid solution (K2SO4)Z fall into the further narroWed range set in Which x is containing peroxymonosulfuric acid and hydrogen peroxide. 0.53-0.64, y is 015-037, and Z is 015-037. The ?rst Caro’s acid solution is then combined With oleum [0087] When mole fractionx equals 0.53 at the loWer end of containing sulfuric acid and sulfur trioxide (S03). The oleum the mole fraction range for potassium hydrogen peroxymono reacts With Water in the ?rst Caro’s acid solution to produce a sulfate in this third set of mole fraction ranges, use of Eq. 7 second Caro’s acid solution. The temperature is maintained yields an RA0 value of approximately of 5.5% When mole beloW 30°, normally beloW 20° C., during the preceding fractions y and Z both are 0.235. Since the upper limit of mole steps. fraction x is 0.64 in this third set of mole fraction ranges, [0082] A potassium compound is added to the second active oxygen content RA0 of potassium monopersulfate Caro’s acid solution to produce a partially neutraliZed solu triple salt composition can readily be chosen to be 55-68% US 2012/0074014 A1 Mar. 29, 2012

by choosing mole fractions x, y, and Z to appropriately fall strontium bromide (SrBr2), barium bromide (BaBrZ), ammo into this third set of mole fraction ranges. nium bromide (NH4Br), lithium iodide (Lil), sodium iodide [0088] People a?llicted With diseases and other debilitating (Nal), potassium iodide (Kl), rubidium iodide (Rbl), cesium medical conditions caused by bacterial, eukaryotic, prion, iodide (Csl), beryllium iodide (Bel2), magnesium iodide and viral pathogens, again including fungal, spore-caused, (M02), calcium iodide (Cal2), strontium iodide (Srl2), and parasitic infections, and by non-pathogenic-caused barium iodide (Bal2), and ammonium iodide (NH4I) provided in?ammation are treated With a medicinal drug formed at that such other halide does not react With the alkali metal least partially With Water-soluble inorganic halide and an phosphate to form an insoluble salt. oxidizing agent reactable in Water, typically aqueous solu [0092] The alkali metal phosphate is normally one or more tion, With the halide to generate hypohalite ions. The medici nal drug is also normally formed at least partially With (anhy of sodium metaphosphate ((NaPO3)n), monosodium phos drous) alkali metal phosphate and sulfamic acid. The phate (NaH2PO4), disodium phosphate (Na2HPO4), triso chemical formula for sulfamic acid, alternatively knoWn as dium phosphate (Na3PO4), tetrasodium pyrophosphate amidosulfonic acid, amidosulfuric acid, aminosulfonic acid, (Na4P2O7), potassium metaphosphate ((KPO3)n), monopo and sulfamidic acid, is H3NSO3. The medicinal drug formed tassium phosphate (KH2PO4), dipotassium phosphate at least partially With the preceding four components is (K2HPO4), tripotassium phosphate (K3PO4), and tetrapotas referred to herein as being of type II. The medicinal drug of sium pyrophosphate (K4P2O7). For each of sodium meta type II can also be administered to persons for preventing phosphate and potassium metaphosphate, n is a plural integer, them from contracting debilitating medical conditions caused i.e., n is 2 or more. Sodium metaphosphate can, for example, by bacterial, eukaryotic, prion, and viral pathogens, including be implemented With sodium hexametaphosphate ((NaPO3) fungal, spore-caused, and parasitic infections, and by non 6) or/and sodium trimetaphosphate ((NaPO3)3). Potassium pathogenic-caused in?ammation. metapho sphate can similarly be implemented With potassium [0089] The oxidizing agent used in forming the medicinal hexametaphosphate ((KPO3)6) or/and potassium trimeta drug of type II contains active oxygen-releasing material that phosphate ((KPO3)3). readily releases oxygen under certain conditions at standard [0093] The material used to form the medicinal drug of type temperature and standard pres sure. More particularly, oxygen II may include a non-reducing organic acid, normally malic is readily released by the active-oxygen-releasing material acid (HOZCCHZCHOHCOZH) or succinic acid When it is present in Water, typically in aqueous solution. The (HO2CCH2CH2CO2H). The ratio of the mole fraction PW oxidizing agent typically may include additional oxygen ROA of the non-reducing organic acidto mole fraction FMAORM containing material, referred to here as inactive material, of the active oxygen-releasing material in the drug of type II Which does not readily release oxygen under the same con is normally 0.01-50, preferably 0.05-5, more preferably 0.1 ditions at standard temperature and pressure for Which the I, typically 0.25. active oxygen-releasing material readily releases oxygen. [0094] The material used to form medicinal drug of type 11 [0090] The ratio of the mole fraction FMHI of the inorganic may also include a surfactant, typically sodium dodecylben halide to the mole fraction FMAORM of the active oxygen zene sulfonate (N aC l8H29SO3). Other candidates for the sur releasing material in the medicinal drug of type II is normally factant are lauryl ether sulfates, ethylene oxide/propylene 0.01 -4, preferably 0.02-2, more preferably 0.03-1, even more oxide alkyl phenol condensates, polyglycol ethers of fatty preferably 0.04-0.5, typically 0.06-0.18. The ratio of the mole alcohols, fatty acid ethylene oxide condensates, polyglycol fraction FMAMP of the alkali metal phosphate to mole fraction ethers of aklyn phenols, and fatty alcohol ethoxylates. The F MA OR M of the active oxygen-releasing material in the drug of ratio of the mole fraction FMSF of the surfactant to mole type II is normally 0.04-40, preferably 0.1-5, more preferably fraction FMAORM of the active oxygen-releasing material in 0.2-1, typically 0.4 The ratio of the mole fraction FMSA of the drug of type II is normally 0.03-30, preferably 0.05-10, sulfamic acid to mole fraction FMAORM of the active oxygen more preferably 0.1-10, typically 0.3. releasing material in the drug of type II is normally 0.03-30, [0095] The medicinal drug of type II is, as discussed further preferably 01-10, more preferably 0.2-1, typically 0.35-0.7. beloW, often provided in a therapeutically inactive pharma [0091] The inorganic halide is normally sodium chloride ceutically acceptable liquid carrier, normally Water. Each of (NaCl), an alkali metal halide. The inorganic halide can alter the components, including the oxidizing agent, of the mate natively or additionally include one or more other alkali metal rial used to form the drug of type II is then soluble, e.g., Water halides, one or more alkaline earth metal halides, or/and one soluble, in the carrier, colloidably suspendable in the carrier, or more ammonium halides. In particular, the inorganic or in liquid form so as to be miscible or emulsible With the halide can alternatively or additionally include one or more of carrier. The components used to form the drug of type II are lithium ?uoride (LiF), sodium ?uoride (N aF), potassium preferably all Water soluble such that the drug of type II is ?uoride (KF), rubidium ?uoride (RbF), cesium ?uoride Water soluble. (CsF), beryllium ?uoride (BeFZ), magnesium ?uoride [0096] The active-oxygen-releasing material in the oxidiz (MgFz), calcium ?uoride (CaFZ), strontium ?uoride (SrF2), ing agent for the medicinal drug of type II normally includes barium ?uoride (BaFZ), ammonium ?uoride (N H4F), lithium persulfate or/and peroxyphthalate. Persulfate candidates for chloride (LiCl), potassium chloride (KCl), rubidium chloride the active-oxygen-releasing material include peroxymono (RbCl), cesium chloride (CsCl), beryllium chloride (BeCl2), sulfates (having SO5-2 groups) and peroxydisulfates (having magnesium chloride (MgCl2), calcium chloride (CaCl2), S208“2 groups). The active-oxygen-releasing material pref strontium chloride (SrClZ), barium chloride (BaCl2), ammo erably includes peroxymonosulfate, i.e., salt of peroxymono nium chloride (N H4Cl), lithium bromide (LiBr), sodium bro sulfuric acid, such as alkali metal salt, alkaline-earth metal mide (NaBr), potassium bromide (KBr), rubidium bromide salt, or/and ammonium salt of peroxymonosulfuric acid. (RbBr), cesium bromide (CsBr), beryllium bromide (BeBrZ), More preferably, the salt of peroxymonosulfuric acid magnesium bromide (MgBrZ), calcium bromide (CaBr2), includes potassium hydrogen peroxymonosulfate. US 2012/0074014 A1 Mar. 29, 2012

[0097] Other sulfur-containing candidates for the active drug of type II. The composite drug of types I and II is referred oxygen-releasing material in the oxidizing agent for the to here as the medicinal drug of “type I/II”. medicinal drug of type II include thiosulfates (having S203“2 [0101] The medicinal drug of type I/II is preferably formed groups). A peroxyphthalate candidate for the active-oxygen With potassium hydrogen peroxymonosulfate as the active releasing material is potassium monoperoxyphthalate. The oxygen-releasing material, sodium chloride as the inorganic active-oxygen-releasing material can alternatively or addi halide, sodium hexametaphosphate as the alkali metal phos tionally be implemented With chlorine-oxygen-containing phate, sulfamic acid, malic acid as the non-reducing organic compounds such as hypochlorites (having ClO' groups), acid, and sodium dodecylbenZene sulfonate as the surfactant. chlorites (having ClO2 groups), chlorates (having ClO; The potassium hydrogen peroxymonosulfate in this formula groups), and perchlorates (having ClO4_ groups) and With tion is normally provided as a component of potassium other analogous halogen compounds. One hypochlorite monopersulfate triple salt composition. The mass fractions of example is sodium hypochlorite (NaClO). potassium hydrogen peroxymonosulfate, potassium hydro [0098] To the extent not mentioned above, the active-oxy gen sulfate, and potassium sulfate in potassium monopersul gen-releasing material in the oxidiZing agent for the medici fate triple salt composition (KHSO5)x(KHSO4)y(K2SO4)Z are nal drug of type II may include oxygen-releasing salts such as approximately 45%, 25%, and 30% in this formulation so that alkali metal salts (particularly potassium, sodium, and mole fractions x, y, and Z are respectively approximately lithium salts), alkaline earth metal salts (particularly calcium 46%, 28%, and 26%. and magnesium salts), and ammonium salts of other inor [0102] As mentioned above, neither potassium hydrogen ganic and organic acids. Other candidates for the active sulfate nor potassium sulfate readily releases oxygen under oxygen-releasing material are the alkali metal and ammo the same conditions at standard temperature and pressure for nium salts of permanganic acid (HMIIO4), especially Which potassium hydrogen peroxymonosulfate readily potassium permanganate (KMnO4) but also potentially releases oxygen. Consequently, the potassium hydrogen sul lithium permanganate (LiMnO4)> sodium permanganate fate and potassium sulfate in potassium monopersulfate triple (NaMnO4), rubidium permanganate (RuMnO4), cesium per salt composition of potassium monopersulfate triple salt manganate (CsMnO4), and ammonium permanganate composition constitute inactive material of the material used (NH4MnO4). Insofar as the drug of type II is provided in a to form the preceding preferred formulation of the medicinal therapeutically inactive pharmaceutically acceptable liquid drug oftype I/II. carrier, again normally Water, all of these candidates for the [0103] The number Mp of moles of each component CP active-oxygen-releasing material need to be soluble, e.g., used in forming a multi-component product consisting of a Water soluble, in the carrier, colloidably suspendable in the total of MT moles is: carrier, or in liquid form so as to be miscible or emulsible With the carrier. MPIFMFMT (13) [0099] The oxidiZing agent for the medicinal drug of type II Where FMP again is the mole fraction of component CP and may further include peroxide (O4O_2 anion) including Where the sum of all mole fractions FMP again equals 1. The hydrogen peroxide (H2O2), oxide (0'2 anion) including sub molar ratio RMb/a is the ratio of the number Mb of moles of a oxide (also 0'2 anion), chromium trioxide (CrO3), osmium component Cb in the product to the number Ma of moles of a tetroxide (OsO4), and chlorine dioxide (ClO2), dioxygenyl component C b in the product. Using Eq. 13, molar ratio RMb/a compound (O2+ ion), oxyanion compound (AxOy_Z ion Where 1s: A is an element and Z is a charge number), peroxydisulfate RMb/aIFMZ/FMa (14) (also denominated as persulfate) ($208“2 anion) including ammonium peroxydisulfate ((NH4)2S2O8), potassium per The parameter FMb/FMa is the mole fraction ratio RFMb/a, i.e., oxydisulfate (KZSZOS), and sodium peroxydisulfate the ratio of the mole fraction PM, of component Cb in the (Na2S2O8), sulfoxide (RiS(:O)iR'), sul?te (SO;3 product to the mole fraction PM, of component Ca in the anion), sulfur dioxide (SOZ), nitrate (NO3 anion), chromate product. Hence, mole fraction ratio RFMb/a equals molar ratio (CrO4_2 anion) including pyridinium chlorochromate, RMb/a' dichromate (Cr2O7_2 anion), phosphite (PO;3 anion), hypo [0104] Using Eq. 8, mole fraction ratio RFMb/a and molar phosphite (HZPO2 anion), oxoacid (or oxyacid) including ratio RMb/a are given as: sulfur oxoacid and phosphorus oxoacid, peracetic acid (CH3CO3H), ascorbic acid (C6H8O6), formic acid (HCOZH), or/and oxalic acid (C2H2O4). [0100] When the active-oxygen-releasing material consists at least partially of salt of peroxymonosulfuric acid such as potassium hydrogen peroxymonosulfate, the medicinal drug of type II implements the medicinal drug of type I for the Where PM and PM are the respective mass fractions of com situation in Which the drug of type I is formed With salt of ponents Ca and Cb in the product and Wu and Wb are the peroxymonosulfuric acid and one or more other components respective molecular Weights of components Ca and C 1,. Con aside from material closely bonded to the salt of peroxy sequently, the ratio Rmb/a of the mass fraction (or mass per monosulfuric acid. More particularly, When the salt of per centage) PM, of component C b to the mass fraction (or mass oxymonosulfuric acid consists of potassium hydrogen per percentage) PM of component Ca is: oxymonosulfate provided as a component of potassium monopersulfate triple salt composition, the drug of type II implements the drug of type I for the situation in Which the W (16) drug of type I is formed With potassium hydrogen peroxy Rmb/a = b ) monosulfate and one or more components other than the potassium hydrogen sulfate and the potassium sulfate in potassium monopersulfate triple salt composition. All of the Eq. 16 can be employed to convert mole fraction (or molar) preceding comments about the drug of type I then apply to the ratios into mass fraction ratios and thus into mass fractions. US 2012/0074014 A1 Mar. 29, 2012

[0105] Potassium hydrogen peroxymonosulfate as the sodium stearate, polyoxyethylene and mixtures thereof), active oxygen-releasing material, sodium chloride as the lubricants (such as magnesium stearate, polyethylene glycol, inorganic halide, sodium hexametaphosphate as the alkali and sodium benZoate), stabiliZing agents, solution adjuvants metal phosphate, sulfamic acid, malic acid as the non-reduc (such as glutamic acid and aspartic acid), Water-absorbable ing organic acid, and sodium dodecylbenZene sulfonate as the materials (such as fumed silica, sodium carbonate, magne surfactant are present at the folloWing mass percentages of the sium carbonate, and potassium carbonate) for reducing mois overall material used to form the preceding preferred formu ture, and effervescents (such as cellulose calcium glycolate, lation of the medicinal drug of type U11: bicarbonate, carbonate, sodium bicarbonate, sodium carbon [0106] a. Potassium hydrogen peroxymonosulfatei ate, and citric, adipic, and tartaric acids or other similar normally 2-95%, preferably 6-90%, more preferably organic acids) for releasing carbon dioxide to assist With 10-60%, typically 20-25%; effervescence in causing the solid drug material to disinte [0107] b. Sodium chlorideinormally 0.001-30%, pref grate. Carbon dioxide and sodium bicarbonate may also assist erably 0.005-7.5%, more preferably 0.01 -5%, typically in therapeutic activity. Additionally, dyes, other coloring 0.5-1 .5%; agents, ?avoring agents, fragrances, corrosion inhibitors, [0108] c. Sodium hexametaphosphateinormally activity indicators, and organic activators can be applied to 2-60%, preferably 5-45%, more preferably 10-30%, the solid forms of the drug of type I or H. typically 18%; [0115] Semiliquid forms of the medicinal drug of type I or [0109] d. Sulfamic acidinormally 1-30%, preferably 11 include gels, creams, pastes, and ointments. When the drug 1.5-15%, more preferably 3-10%, typically 5-10%; of type I or II is provided in semiliquid form, the drug is [0110] e. Malic acidinormally 0.1-40%, preferably normally dispersed throughout a therapeutically inactive 05-30%, more preferably 1-20%, typically 5-10%; and pharmaceutically acceptable carrier, normally a semiliquid [0111] f. sodium dodecylbenZene sulfonateinormally carrier. Although the carrier is normally semiliquid, the drug 1-50%, preferably 7.5-37.5%, more preferably 10-25%, of type I or H can itself be solid, semiliquid, or even liquid if typically 15%. the drug is a suitable small mass percentage of the carrier. In The remainder of the material used to form this formulation of a typical semiliquid form of the drug of type I or H, the drug the medicinal drug of type l/ll largely consists of the potas itself consists of solid particles. The semiliquid drug of type I sium hydrogen sulfate and the potassium sulfate in the potas or 11 may be provided With various additives such as Wetting sium monopersulfate triple salt composition that provides the agents, emulsifying agents, dyes, other coloring agents, ?a potassium hydrogen peroxymono sulfate. voring agents, fragrances, corrosion inhibitors, activity indi [0112] The medicinal drug of type I or 11 (including the cators, organic activators, stabiliZers, and buffering agents. medicinal drug of type l/ll) may be provided in solid, semi [0116] Liquid forms of the medicinal drug of type I or 11 liquid, or liquid form. The term “semiliquid” refers here to include solutions, suspensions, lotions, emulsions, liniments, matter having properties betWeen a solid and a liquid. The syrups, elixirs, and tinctures. In some cases, the dividing line viscosity of semiliquid matter is suf?ciently high that the betWeen liquid and semiliquid forms of the drug of type I or semiliquid matter, When placed on a surface, ?oWs sloWly and H is unclear. When the drug of type I or II is provided in liquid does not rapidly adopt the shape of the underlying surface. form, the drug is typically dispersed throughout a therapeu This contrasts to liquid matter Which, When placed on a sur tically inactive pharmaceutically acceptable liquid carrier. face, readily ?oWs and rapidly adopts the shape of the under Similar to semiliquid forms of the drug of type I or II, the drug lying surface, typically Within a feW seconds for up to a itself can be solid, semiliquid, or liquid form. In a typical kilogram of the liquid, and to solid matter Which does not liquid form of the drug of type I or H, the drug itself consists How. As indicated beloW, a semiliquid form of the drug of type of solid particles dissolved or colloidably suspended in the I or H normally has a dynamic (or absolute) viscosity of carrier. The liquid carrier is normally Water (puri?ed and/or 5-5,000 Pa-s at 25° C. distilled) but can be ethanol or a mixture of ethanol and Water. [0113] Solid (dry) forms of the medicinal drug of type I or The liquid drug of type I or 11 may be provided With additives II are poWders and tablets (pills) Which disintegrate in the such as Wetting agents, suspending agents, emulsifying body When taken orally. When the drug of type I or H is agents, dyes, other coloring agents, ?avoring agents, fra provided in solid form, the drug itself is in solid form and is grances, corrosion inhibitors, activity indicators, organic acti normally dispersed largely throughout a therapeutically inac vators, stabiliZing agents (such as sodium sulfate), and buff tive pharmaceutically acceptable solid carrier. PoWder imple ering agents. mentations of the drug of type I or 11 may be enclosed in [0117] As discussed further beloW, liquid forms of the Water-soluble capsules (small closed containers such as jack medicinal drug of type I or H can be administered by injection ets, sachets, ?lms, and the like) Which disintegrate in the body or spraying. In addition to Water or/and ethanol, the liquid When taken orally. Coating agents (such as sugar, gelatin, carrier for drug injection may include one or more of veg hydroxypropyl cellulose, and hydroxypropylmethyl cellu etable oil, propylene glycol, polyethylene glycol, solution lose phthalate) may be variously provided in one or more adjuvants (such as glutamic acid and aspartic acid), and layers or ?lms on the tablets and capsules. The tablets and soothing agents. The liquid carrier for drug spraying may capsules can be structured to provide metered-release forms include isotonic buffers (such as sodium chloride, sodium of the drug of type I or II. citrate, and citric acid). [0114] The folloWing materials can be variously admixed [0118] The peroxymonosulfate used in forming the medici into solid poWder and tablet forms of the medicinal drug of nal drug of type I can be combined With any other component type I or 11: vehicles (such as lactose, mannitol, glucose, of the drug and With a therapeutically inactive pharmaceuti microcrystalline cellulose, and starch) Which help deliver the cally acceptable carrier for the drug according to various drug ingredients, binders (such as hydroxypropyl cellulose, techniques. The oxidiZing agent, preferably peroxymonosul polyvinylpyrrolidone, magnesium metasilicate aluminate, fate, used in forming the medicinal drug of type II can simi US 2012/0074014 A1 Mar. 29, 2012

larly be combined With the other components of the drug and stance. The poWdery drug is then combined With the liquid With a therapeutically inactive pharmaceutically acceptable carrier in such a manner as to be distributed throughout the carrier for the drug according to various techniques. In the carrier. following description of such combining techniques for the [0123] The carrier is again a liquid in yet another drug medicinal drugs of types I and II, the term “peroxymonosul formation technique. The peroxymono sulfate material for the fate material” for the drug of type I means both the peroxy medicinal drug of type I is provided in solid particulate form monosulfate, When it is provided as substantially a single salt, and is mixed into the liquid carrier. If the drug of type I is to and a multiple salt composition, such as potassium monop ersulfate triple salt composition for potassium hydrogen per be formed With at least one component besides the peroxy oxymonosulfate, Which contains the peroxymonosulfate as a mono sulfate material, each additional component is provided component. The term “oxidizing agent material” for the drug in solid particulate form or in liquid form. Each additional of type II means both (a) the active oxygen-releasing material component for the drug of type I is then mixed into the liquid When the oxidiZing agent is provided as substantially a single carrier separate from the peroxymonosulfate material. This material and (b) a multi-material composition Which contains technique is applicable to the medicinal drug of type II in a the active oxygen-releasing material as a component. When variation in Which the oxidiZing agent material is again ini the oxidiZing agent consists substantially solely of peroxy tially provided in solid particulate form and in Which each monosulfate, the peroxymono sulfate material is the oxidiZing other components of the drug initially provided in solid par agent material. ticulate form or in liquid form. Each additional component for [0119] In one drug formation technique, the carrier, the the drug of type II is mixed into the liquid carrier separate peroxymonosulfate material, and any other component of the from the oxidiZing agent material. The mixing for the drug of medicinal drug of type I are initially provided in solid par type I or II is performed so that the particles of the drug of type ticulate form. This technique is applicable to the medicinal I or II are distributed throughout the carrier. drug of type II in a variation in Which the carrier, the oxidiZing [0124] When the carrier is a liquid, the particles of the agent material, and the other components of the drug are peroxymonosulfate material and any other drug component initially provided in solid particulate form. The particles for provided in particulate form for the medicinal drug of type I both the drug of type I and the drug of type II are mixed preferably dissolve in the carrier to form a solution and are together to form a poWdery substance. The mixing is nor thereby distributed substantially uniformly throughout the mally performed so that the particles of the drug are distrib carrier. For the medicinal drug of type II, each drug compo uted largely uniformly throughout the carrier. The drug of nent provided in particulate form preferably dissolves in the type I or II is then available for use as a poWder. If desired, the carrier to form a solution and thus is distributed substantially poWder can be inserted into Water-soluble capsules. uniformly throughout the carrier. [0120] Ifthe medicinal drug of type I or II is to be in solid [0125] Alternatively, the particles of the peroxymonosul tablet form, the poWdery substance is suitably processed to fate material and any other drug component provided in par create solid tablets, including tablets that provide metered ticulate form for the medicinal drug of type I can be sus release forms of the drug after it is administered. The pro pended in the carrier to form a colloid or emulsion. As cessing may include providing the tablets With suitable coat necessary, the colloid or emulsion is suitably mixed so that the ings. particles of the peroxymonosulfate material and any other [0121] Largely the same procedure can be folloWed if the drug component provided in particulate form are distributed medicinal drug of type I or II is to be provided in a therapeu substantially uniformly throughout the carrier. For the tically inactive pharmaceutically acceptable semiliquid car medicinal drug of type II, each drug component provided in rier such as a cream, gel, ointment, or foam except that the particulate form can similarly be suspended in the carrier to poWdery substance is suitable processed to form the semiliq form a colloid or emulsion. As necessary, the colloid or emul uid carrier With the drug particles distributed throughout it. sion is likeWise suitably mixed so that the particles of the Alternatively, the carrier can initially be provided in semiliq oxidiZing agent material and each other drug component pro uid form With the drug of type I or II furnished in solid vided in particulate form are distributed substantially uni particulate form. If the drug of type I contains at least one formly throughout the carrier. component besides the peroxymonosulfate material, the par [0126] In some of the techniques for combining the peroxy ticles of the drug components are mixed together. Since the mono sulfate material and at least one other component of the drug of type II has multiple components, its components are medicinal drug of type I With the carrier, the peroxymonosul simply mixed together. The particles of the drug of type I or II fate may react With another drug component, typically in the are then mixed into the carrier. The mixing for the drug of type carrier. If the drug of type I is to be formed With at least tWo I or II is normally performed so that the drug particles are components besides the peroxymonosulfate material, tWo or distributed largely uniformly the semiliquid material of the more of these other components may react With one another, carrier. again typically in the carrier. The peroxymonosulfate or/and [0122] In a further drug formation technique Where the any other drug component besides the peroxymonosulfate carrier is to be a liquid and Where the medicinal drug of type material may even react With the carrier. The possibility of I is to be formed With at least one component besides the such reaction(s) is greater When the carrier is a liquid such as peroxymonosulfate material, the components of the drug are Water. As a result, the chemical structure of the ?nal constitu provided in solid particulate form. This technique is appli ents of the drug of type I may differ from the chemical cable to the medicinal drug of type II in a variation in Which structure of the components used to form the drug. Nonethe the oxidiZing agent material and other components of the less, the drug of type I can reasonably be described as being drug are initially provided in solid particulate form. The par “formed” With the peroxymonosulfate material and each ticles of the components of the drug of type I or II are mixed other indicated component and thus as being “formed” at together to form the drug of type I or II as a poWdery sub least partially With the peroxymonosulfate. US 2012/0074014 A1 Mar. 29, 2012

[0127] As indicated above, the oxidizing agent for the monoxide (CO), xenon @(e), ozone (O3), nitrogen dioxide medicinal drug of type II is reactable in Water, typically (N02), iodine (l2), ammonia (NH3), Water vapor (H2O), aqueous solution, With the halide to generate halite ions. The or/ and hydrocarbons. chemical formula for a hypohalite is XOH (or HOX) Where X [0131] The medicinal drug of types I and II is administered represents a halogen such as ?uorine, chlorine, bromine or in various Ways to people a?licted With diseases and other iodine. A hypohalite ion thus has the chemical formula XO'. debilitating medical conditions caused by bacterial, eukary When the therapeutically inactive pharmaceutically accept otic, prion, and viral pathogens, including fungal, spore able carrier is a Water-containing liquid and When the oxidiz caused, and parasitic infections, and by non-pathogenic ing agent and the halide are dissolved in the Water or are caused in?ammation. In general, the drug of type I or II can be suspended in colloidal form in the Water, hypohalite ions are administered to a person by any procedure or/ and route Which thereby produced by reaction of the oxidizing agent With the enables the drug to reach the particular location(s) af?icted With the disease to be alleviated by the drug. Depending on halide. Consequently, the chemical structures of some of the components of the drug of type II in the Water-containing various factor including the nature of the disease, the admin istration technique can be global, i.e., systemic, or local and carrier differ from the chemical structures of the correspond thus targeted at the diseased location(s). ing components used to form the drug of type II. HoWever, the [0132] A topical technique is often used to administer the reaction does not normally cause any signi?cant precipitation medicinal drug of type I or II. As used herein, topical admin of hypohalite material, modi?ed oxidizing agent material, or istration generally means bringing the drug of type I or II into any other material. The drug of type II can reasonably be contact With the outer surface, typically the skin, of the human described as being “formed” With the inorganic halide, sul body and not by introducing the drug into the human body via famic acid, alkali metal phosphate, and the oxidizing agent, one or more major openings, i.e., openings other than pores, and When used, the organic acid and the surfactant. naturally present along or/and one or more openings arti? [0128] The Water for the medicinal drug of type I and II may cially formed along the outer surface of the human body. consist of, or include, any one or more of tap Water, drinking Topical administration can be performed by manually bring Water, puri?ed Water, hypertonic Water, hypotonic Water, iso ing the drug of type I or II into contact With the body, by tonic Water, oxidative reductive potential Water, super-oxi spraying, by immersion (bath or soak), by skin or/ and trans dized Water, Water for injection, Milli-Q Water, saline Water, dermal patch coated With the drug of type I or H and an heavy Water (Water containing a higher-than-normal propor adhesive placed on the skin to deliver the drug to the skin tion of deuterium in the form of deuterium protium oxide or or/ and through the skin and into the bloodstream, and by other deuterium oxide), light Water (Water depleted of deuterium), techniques Which physically bring the drug into contact With and tritiated Water (Water in Which hydrogen is replaced With the body. The drug of type I or H can be in solid poWder form, semiliquid form, or liquid form during topical administration. tritium). Puri?ed Water includes deionized Water, distilled Topical administration of the drug of type I or H on an eye, Water, double distilled Water, United States Pharmacopeia typically With the drug in liquid form, can be performed by puri?ed Water, laboratory-grade puri?ed Water, analytical spraying the drug into the eye, vaporizing the drug into the grade puri?ed Water, or/ and reagent- grade puri?ed Water. The eye, or/ and With eye drops. Water puri?cation techniques for the drug of type I or II [0133] The medicinal drugs of types I and H can also be include ultra performance liquid chromatography, high per administered non-topically. Non-topical administration, the formance liquid chromatography, distillation, and reverse converse of topical administration, generally here means osmosis. introducing the drug of type I or II into the human body via [0129] The additives, including stabilizers, for the medici one or more major openings naturally present along or/and nal drug of type I and H may include oxidative reductive one or more openings arti?cially formed along the outer potential Water, super-oxidized Water, activity indicators, surface of the human body. Non-topical techniques for adjuvants, anti-adherents, anti-foaming agents, antioxidants, administering the drug of type I or H include oral administra anti-spotting agents, aromas, binders, bioenhancers, buffer tion, intranasal administration, intraotical administration, ing agents, carriers, catalysts, chelating agents, clari?ers, vaginal administration, rectal administration, urethral admin coatings, corrosion inhibitors, de?occulants, diluents, dis istration, and injection altematively referred to as infusion or persants, distillers, dyes, colorants, pigments, emulsi?ers, parenteral administration. enterics, enzymes, excipients, ?llers, ?avors, ?occulants, [0134] Oral administration is normally done With the foaming agents, glidants, hydrotropes, lubricants, preserva medicinal drug of type I or II in solid tablet, capsule, or tives, opacifying agents, organic activators, oxygen stabiliz poWder form but can be done With the drug in liquid form and ers, preservatives, scale inhibitors, sequestrants, sorbents, sometimes With the drug in semiliquid form. The tablets, solubilizers, suspending agents, sWeeteners, ultraviolet stabi capsules, and poWders may provide metered release of the lizers, vaporbarriers, viscosity modifying agents, or/ and Wet drug of type I or II. For oral administration of the drug of the ting agents. drug of type I or H in liquid or semiliquid form, the drug can [0130] Devices for dispensing, or delivering, the medicinal also be placed in the mouth Without having the drug go drug of type I or/and ll include, aerosol or/ and elevated pres substantially through the esophagus to the stomach. For sure containers, atomizers, dry poWder inhalers, foggers, mist instance, a liquid form of the drug of type I or II can be sprayers, nebulizers, spray and steam devices, vaporizers, administered orally by spraying the drug into the mouth or by metered-dose inhalers or/and dry poWder inhalers. The gases placing the drug in the mouth and then gargling. A poWder or or/and propellants used in these dispensing or delivering vapor containing the drug of type I or II can be orally inhaled. devices include nitrogen (N2), oxygen (O2), argon (Ar), car [0135] lntranasal administration in Which the medicinal bon dioxide (CO2), neon (Ne), helium (He), methane (CH4), drug of type I or H enters at least one of the nostrils is typically krypton (Kr), hydrogen (H2), nitrous oxide (N20), carbon done With the drug of type I or II in liquid form. lntranasal US 2012/0074014 A1 Mar. 29, 2012

administration of the drug of type I or II can be performed by drug of type I or II can be combined With metered-release inhalation into a nostril, spraying into a nostril, vaporizing the forms of the drug to obtain desired therapeutic effects. drug into a nostril, With nose drops, or/and by other tech [0141] The range of administered dosages of the medicinal niques Which physically bring the drug into contact With the drug of type I or II varies depending upon the selected route of inside of a nostril. administration, the recipient’s characteristics, including age, [0136] Intraotic administration can done With the medici body Weight, general state of health, desired therapeutic nal drug of type I or II in solid poWder form, semiliquid form, effect, the duration of the treatment, and the disease or other and liquid form. In intraotic administration of the drug of type debilitating medical condition being treated With the drug. The drug of type I or II can, for example, be separately I or II, the drug typically enters the ear canal. Intraotic admin administered normally 1-12 times per day, preferably 1-8 istration of the drug of type I or II into the ear canal can be times per day, more preferably 1 -6 times per day, typically 1 -4 performed by manually bringing the drug into contact With times per day, at selected unit dosages or continuously admin the ear canal, by spraying into the ear canal, With ear drops, istered for selected periods at selected rates by suitable con vaporizing the drug into the ear canal, by immersion, or/and tinuous administration techniques, such as intravenous inj ec by other techniques Which physically bring the drug into tion, to achieve selected total dosage amounts. Unit dosages contact With the ear canal. Spraying can be done With nebu can be combined With metered-release dosages to obtain lizers to achieve selected dosages. Intraotic administration of desired therapeutic effects. the drug of type I or II also includes introducing the drug into [0142] The medicinal drug of type I or II can be adminis the middle ear or/ and the inner ear and thus past the eardrum. tered more than 12 times daily depending on the nature of the [0137] Vaginal and rectal administration can done With the particular disease or other debilitating medical condition medicinal drug of type I or II in solidpoWder form, semiliquid being treated With the drug. The concentration of the drug of form, and liquid form. Urethral administration is typically type I or II in its solid, semiliquid, or liquid carrier may exceed done With the drug of type I or II in liquid form. Pessaries, 5% by mass in some cases. The total administered amount and suppositories, enemas and the like can be variously employed administration schedule is selected so the drug of type I or II in vaginal, rectal, and urethral administration of the drug of is therapeutically effective in alleviating the symptoms of the type I or II. disease or other debilitating medical condition While being [0138] Administration by injection is typically done With non-toxic or otherWise injurious to the recipient. Addition the medicinal drug of type I or II in liquid form. Types of ally, the drug of type I or II may be used With many other injection administration of the drug of type I or II include medicines and therapies. intravenous, intramuscular, subcutaneous, intracardiac, intra [0143] The time period during Which a person is treated cavernosal, intradermal, intraosseous, intraperitoneal, and With the medicinal drug of type I or II varies depending upon intrathecal injection. the desired therapeutic effect, the particular disease or other [0139] The concentration of the medicinal drug of type I or debilitating medical condition being treated With the drug, II in its solid, semiliquid, or liquid carrier is normally and the person’s characteristics, including age, body Weight, 0.00001 -5%, preferably 0.001 -3%, more preferably, 0.1 -2%, and general state of health. The treatment period is chosen to typically 0.5-1%, by mass. These ranges are particularly be therapeutically effective in alleviating the symptoms of the applicable to the medicinal drug of type I/II for Which the disease being treated While avoiding toxicity dif?culties With active oxygen-releasing material in the oxidizing agent for the drug of type I or II. The treatment period With the drug of the drug of type II consists substantially of peroxymonosul type I or II is normally 1 day-12 months, preferably 1 day-6 fate, preferably potassium hydrogen peroxymonosulfate, months, more preferably 1 day-3 months, and typically 1-30 used in forming the drug of type I and for Which the material days. Nonetheless, the treatment can extend over multiple used in forming the drug of type I or II includes inorganic years. halide, alkali metal phosphate, and sulfamic acid. The spe [0144] The treatment plan for the medicinal drug of type I ci?c concentration is chosen to be therapeutically effective or II can be a one-time treatment, daily treatments, Weekly and non-toxic When administered in the Ways described treatments, monthly treatments, yearly treatments, or/ and a above. long term treatment plan. Depending on the severity of the [0140] The time during Which the medicinal drug of type I debilitating condition of the person being treated With the or II is in contact With the area under treatment, especially for drug of type I or II, the treatment plan varies Widely as shoWn topical administration of the drug, varies depending upon the by the examples presented beloW. Treatment With the drug of selected route of administration, the desired therapeutic type I or II can be used as a preventative measure or/and effect, and the particular disease or other debilitating medical infrequently to maintain a healthy lifestyle. condition being treated With the drug. The time of contact for [0145] The medicinal drug of type I or II is particularly a liquid form of the drug of type I or II is normally 1 minute-12 useful in treating allergic rhinitis, arthritis, bronchitis, hem hours, preferably 1 minute-6 hours, more preferably 1 orrhoids, urticaria, toothache, tinea pedis, acute viral minute-2 hours, typically 1-30 minutes. The time of contact nasopharyngitis, herpes simplex, dandruff, itching, brom for a semiliquid form of the drug of type I or II is normally 1 hidrosis, and vaginitis. The types of arthritis include osteoar minute-12 hours, preferably 1 minute-6 hours, more prefer thritis and gouty arthritis. The drug of type I or II may be used ably 1 minute-2 hours, typically 30 minutes-1 hour. The time to treat many other diseases and otherWise debilitating medi of contact for a solid form of the drug of type I or II is cal conditions. Other uses of the drug of type I or II include normally 1 minute-12 hours, preferably 1 minute-6 hours, uses as an analgesic for treating pain and headaches, as an more preferably 1 minute-2 hours, typically 30 minutes-1 antipyretic for treating fever, as a detoxifying agent for treat hour. The preceding times of contact for liquid, semiliquid, ing hypersensitivity to various drug or/and body reactions, as and solid forms of the drug of types I and II apply to continu a cutaneous agent for treating debilitating skin conditions, as ous administration of the drug. The time-of-contact of the an hematologic for treating blood diseases and other cardiac US 2012/0074014 A1 Mar. 29, 2012

conditions, as a treatment for genetic or hereditary disorders, thritis Without effective relief. The Medicine Was provided to as a palliate for reducing conditions, as an idiopathic for the male as a 1% solution for topical administration via com treating unknown causes of a condition, and as an antidote for plete-body immersion (bath) for 15 minutes, With morning preventing or counteracting poisons and other such toxic and night applications, for a minimum of 2 Weeks. The male conditions. reported that, after 7 days of treatment, the pain Was relieved [0146] Given below are examples of using the medicinal greatly and that, after 14 days of treatment, the pain Was very drug of type l/ll for treating allergic rhinitis, osteoarthritis, minimal. The male reports that he noW uses the Medicine at gouty arthritis, bronchitis, hemorrhoids, urticaria, toothache, least tWice a Week to reduce pain of osteoarthritis. tinea pedis, acute viral nasopharyngitis, herpes simplex, dan druff, itching, bromhidrosis, and vaginitis. The formulation of the drug of type l/ll used in these examples Was the pre Example C ferred formulation, mentioned above, in Which the drug Was formed With potassium hydrogen peroxymonosulfate as the Gouty Arthritis active oxygen-releasing material, sodium chloride as the inorganic halide, sodium hexametaphosphate as the alkali [0150] A retired adult male had gouty arthritis for 10 years. metal phosphate, sulfamic acid, malic acid as the non-reduc The male reported that he Was in excruciating pain on random ing organic acid, and sodium dodecylbenZene sulfonate as the days and that previously attempted treatments for the pain surfactant at approximately the typical mass percentages Were unsuccessful. The Medicine Was provided to the male as mentioned above. A formulation approximating this forrnu a 1% solution for topical administration via complete-body lation is commercially available in the product Virkon. This immersion once a day, before bedtime, for a minimum of 20 formulation of the drug of type l/ll is referred to beloW as the minutes for 7 days. The male reported that the pain Was “Medicine”. greatly relieved on day 4. The male reports that he noW sleeps [0147] The Medicine for each person infected With allergic better than in many previous years and that he continues to use rhinitis, osteoarthritis, gouty arthritis, bronchitis, hemor the Medicine at least tWice a Week as a treatment and preven rhoids, urticaria, toothache, tinea pedis, acute viral nasophar tative. yngitis, herpes simplex, dandruff, itching, bromhidrosis, and vaginitis is provided for topical, intranasal, oral, or/and inj ec tion administration 1-12 times per day, preferably 1-8 times Example D per day, more preferably 1-6 times per day, typically 1-4 times per day, in liquid form at a dosage of 0.00001-5%, preferably Bronchitis 0.001-3%, more preferably 0.1-2%, typically 0.5-1%, for a time of contact of 1 minute-12 hours, preferably 1 minute-6 [0151] An adult female had severe coughing and sputum hours, more preferably 1 minute-2 hours, typically 1-30 min due to bronchitis. The female reported that the bronchitis had utes. The treatment period in each in each of the folloWing been intermittent for 10 years and that she had tried many examples is normally 1 12 months, preferably 1-6 months, treatments for her bronchitis and consumed substantial more preferably 1-3 months, typically 1-30 days. amounts of Water daily With no success. The Medicine Was provided to the female as a 0.1% solution for oral adminis Example A tration by spraying into the mouth 3 times per day at 4-hour Allergic Rhinitis intervals for 7 days. After the 7 days, the female reported that her bronchitis Was greatly alleviated, that the urge to cough [0148] A teenage female had allergic rhinitis. The female had diminished greatly, and that the sputum Was virtually stated that she experienced annual episodes of itching, bum gone. The female reports that she noW feels better than she has ing, congestion, and Watering of mucosal membranes appar in the past 10 years. ently resulting from hypersensitivity to plant allergens. The Medicine Was provided to the female as a 1% solution for intranasal administration by spraying into the nostrils 3 times Example E a day at 4-hour intervals for 2 Weeks. The female reported that her allergic rhinitis symptoms Were relieved after 3 days and Hemorrhoids that the symptoms virtually disappeared after 10 days. The female then stopped using the Medicine. The female reported [0152] An adult female had hemorrhoids for over 5 years. that the allergy symptoms returned after 14 more days, that The female stated that the hemorrhoids Were so severe as to she resumed taking the Medicine, and that the symptoms prevent her from Working, that she Was con?ned to bed during disappeared Within several more days. As a preventative mea most of each day due to severe pain in Walking and standing, sure, the female reports that she noW uses the Medicine before and that the pain Was almost unbearable during boWel move hay fever season. ments. The Medicine Was provided to the female as a 1% solution for rectal/topical administration 1-2 times a day for Example B 14 days. For the rectal/topical administration, the female Was instructed to perform boWel movements in a container ?lled Osteoarthritis With the Medicine to a level so that her buttocks Were com [0149] A retired adult male had osteoarthritis for 10 years. pletely immersed in the Medicine, so that the Medicine con The male stated that he Was in constant pain throughout the tacted the outer layer of the anus, and so that the Medicine day, thereby limiting his life substantially to his surroundings. moved through the anus into the rectum. After each boWel The male reported that he had tried many treatments, such as movement, the Medicine in the container Was to be discarded. NSAlDs, glucosamine, and glucocorticoids, for his osteoar The female reported that her hemorrhoids Were greatly alle US 2012/0074014 A1 Mar. 29, 2012

viated and that she Was noW able to Walk far distances Which reported the she had tried analgesics and herbal remedies to she had not been able to do for over 5 years. treat the cold sores Without complete success and that she normally ended up Waiting about 7 days for the cold sores to Example F scab over. The Medicine Was provided to the female as a 1% Ur‘ticaria solution for topical administration around the mouth at 3-hour intervals 4 times a day for 7 days. The female reported [0153] An adult female had a severe outbreak of urticaria that, on day 2, the cold sores had become completely ?at With apparently due to consumption of raW seafood. The female the pain and itchiness substantially gone and that the cold stated that she had itchy and bumpy red spots on her face, back sores Were barely visible on day 6. and thighs. The female stated that she had tried many treat ments for her urticaria. The Medicine Was provided to the Example K female as a 0.5% solution for topical administration via com Dandruff plete-body immersion for 20 minutes once a day for a feW days. The female reported that the itchiness Was relieved on [0158] An adult female had dandruff for about 20 years. the night of initial treatment and that her urticaria Was virtu The female stated that she avoided Wearing black clothes due ally gone on day 3. The female also reported that no previous to the dandruff ?aking and that the dandruff caused her to treatment for her urticaria Was as fast acting as the Medicine. have loW self esteem. The female reported that she had tried numerous treatments, such as Zinc pyrithione, ketoconaZole, Example G selenium sul?de, and many types of herbs, to eliminate her Toothache dandruff and that (some of) these treatments did cause the amount of dandruff to decrease but that dandruff Was still [0154] An adult female had a tooth extracted and Was in visible on her scalp. The Medicine Was provided to the female extreme pain due to the tooth extraction. The Medicine Was as a 1% solution for topical administration by scrubbing the provided to the female as a 1% solution for oral administra Medicine into her scalp and hair for 5 minutes and then tion by gargling for 1 minute. The female reported that the Washing her scalp and hair. The female reported that she pain diminished greatly in about 30 minutes. The female administered the Medicine to herself in the foregoing manner further reported that she continued using the Medicine before 4 times a Week for 2 Weeks. After the 2 Weeks, the female bedtime that night and the next day during the morning and reported that the dandruff disappeared. The female reports evening and that, after 2 days of treatment, the toothache pain that the dandruff has not come back. disappeared. Example L Example H Itching Tinea Pedis [0159] An adult male had extreme itching for 5 years. The [0155] An adult male had tinea pedis With itching, crack male reported that he had tried many treatments for the itch ing, and burning lesions of his toes. The Medicine Was pro ing Without success. The Medicine Was provided to the male vided to the male as a 1% solution for topical administration as a 1% solution for topical administration via complete-body via foot immersion for 10 minutes a day for several days. The immersion for 20 minutes 2 times a day for 2 Weeks. The male male reported that his toes Were healed after 5 days and that reported that the itching had diminished by at least 50% on the Medicine Was one of the most effective medications that day 3 and that the itching Was substantially gone at the end of he had ever used. the 2 Weeks. The male reports that he noW uses the Medicine tWice a Week as an itch preventative. Example I Acute Viral Nasopharyngitis Example M [0156] An adult female apparently had viral nasopharyngi Bromhidrosis tis. She reported the typical viral nasopharyngitis symptoms [0160] An adult male had bromhidrosis in the form of of sneeZing, congestion, and fatigue. The Medicine Was pro strong foot odor. The male reported that he tried treatments vided to the female as a 0.1% solution (i) for intranasal such as cologne and deodorant for the bromhidrosis but that administration by spraying and (ii) for oral administration by these treatments caused his skin to sWell and redden. The spraying, each type of administration to be performed 3 times Medicine Was provided to the male as a 1% solution for a day at 4-hour intervals for 4 days. The female reported that topical administration via foot bath immersion for 10 minutes the symptoms of sneeZing, congestion, and restlessness had in the morning and evening for 7 days. After 5 days, the male signi?cantly decreased by day 4 and that they had virtually reported that his foot odor had disappeared. The male further disappeared on the morning of day 5. reported that the foot odor returned about 30 days later, that he then used the Medicine tWice in 2 days, and that the foot odor Example J again Went aWay. Herpes Simplex Example N [0157] An adult female had herpes simplex in the form of herpes labialis as indicated by cold sores around her mouth. Vaginitis The female reported that she contracted the cold sores about [0161] An adult female had vaginitis for 3 years. The 3 times a year, that she felt some pain and itching from the female reported vaginitis symptoms of in?ammation, bum cold sores, and that the external visibility of the cold sores ing, itching, and sWelling after intercourse. The female made her reluctant to meet people. The female further reported that she has tried many treatments, such as topical US 2012/0074014 A1 Mar. 29, 2012

antibiotics, anti-fungal creams, and hydrocortisone, for the Water, more preferably deioniZed Water. The initial liquid vaginitis but Without signi?cant success. The Medicine Was composition thereby has a suitably high initial potency. The provided to the female as a 1% solution for vaginal/topical sub sequent introduction of the disintegrable composition into administration via vaginal immersion for 10 minutes in the the initial liquid composition converts it into a further liquid morning and evening for 2 Weeks. The female reported that composition containing the drug of type I or II. The disinte the burning and itching in the vaginal area Were signi?cantly gration characteristics of the disintegrable composition are reduced on day 2 and that the burning, itching and in?amma chosen so that it disintegrates in such a Way in the further tion in the vaginal area Were greatly alleviated on day 10. The liquid composition as to provide it With suf?cient active female further reports that she continues to use the Medicine oxygen-containing matter of the drug of type I or II to gen after intercourse. erally compensate for active oxygen lost from the further [0162] A metered-release product in accordance With the composition as time passes. This enables the potency of the invention is a disintegrable composition formed With solid further liquid composition to be maintained suitably high for material and suitable for introduction into a liquid, typically an extended period so that the further composition has Water. The disintegrable composition consists at least par extended shelf life. tially of active material formed With the medicinal drug of [0166] The ionic purity of a liquid is generally gauged by its type I or II. Immediately prior to being introduced into the conductivity or its resistivity, the inverse of conductivity. The liquid, the disintegrable composition has a mass mDC of an amount of ioniZation in the liquid increases as its conductivity initial mass value mDCI. The disintegrable composition is of increases or its resistivity decreases, and vice versa. The such a structure that the composition gradually disintegrates conductivity of the deioniZed Water (a) into Which the disin upon introduction into the liquid for enabling particles of the tegrable composition is introduced in the ?rst embodiment of composition to disperse into the liquid. Mass mDC of the sloW metered release of the medicinal drug of type I or II and disintegrable composition is 10% to 90% of initial mass value (b) into Which the selected amount of the drug of type I or II mDCI 1 hour to 100 days after the composition is introduced is introduced in the second embodiment of sloW metered into the liquid. The rate at Which the composition disinte release of the drug of type I or II to form the initial liquid grates is adjusted to accommodate various situations. composition is normally no more than 10 uS/cm, preferably [0163] Relatively fast metered release, e.g., over a small no more than 1 uS/cm, more preferably no more than 0.1 number of hours to a small number of days, of the medicinal [18/ cm, at 250 C. Equivalently, the resistivity of the deioniZed drug of type I or II is appropriate for some situations such as Water at 250 C. is at least 0.2 MQ-cm, preferably at least 1 that in Which the disintegrable composition containing the MQ-cm, more preferably at least 10 MQ-cm, (a) prior to drug of type I or II is provided in suf?ciently large solid form, introducing the disintegrable composition into the deioniZed such as a tablet or a capsule containing a dry poWder of the Water in the ?rst embodiment of sloW metered release and (b) disintegrable composition, for ingestion by a person. For such prior to introducing the selected amount of the drug of type I fast metered release, mass mDC of the disintegrable compo or II into the deioniZed Water in the second embodiment of sition is 10% to 90% of initial mass value mDcll hour to 24 sloW metered release. The carrier for the initial liquid com hours after the composition is introduced into the liquid. position can include oxidative reductive potential Water Preferably, mass mDC of the disintegrable composition for or/ and super-oxidiZed Water. fast metered release is 10% to 90% of initial mass value mDC, [0167] Metered release of the medicinal drug of type I or II 2 hours to 12 hours after the composition is introduced into at a release rate intermediate to fast and sloW metered releases the liquid. In regard to a capsule containing dry poWder of the is appropriate for yet other situations. For such intermediate disintegrable composition, the preceding times begin at the rate metered release, mass mDC of the disintegrable compo point that the capsule has disintegrated suf?ciently so as to sition is 10% to 90% ofinitial mass value mDcll days to 24 expose the active material to the liquid. days after the composition is introduced into the liquid. Pref [0164] Relatively sloW metered release, e. g., over multiple erably, mass mDC of the disintegrable composition for inter months to a small number of years, of the medicinal drug of mediate-rate metered release is 10% to 90% of initial mass type I or II is appropriate for other situations such as that in value mDC, 5 days to 20 days after the composition is intro Which the potency of a liquid form of the drug of type I or II duced into the liquid. The liquid for intermediate-rate is to be maintained suitably high for multiple months to a year metered release is normally Water, preferably high-purity or more. For such sloW metered release, mass mDC of the Water, more preferably deioniZed Water, and can include oxi disintegrable composition is 10% to 90% of initial mass value dative reductive potential Water or/ and super-oxidiZed Water. mDcl25 days to 100 days after the composition is introduced [0168] The disintegrable composition can, as indicated into the liquid. Preferably, mass mDC of the disintegrable above, be provided in the form of solid pieces, e.g., tablets, of composition for sloW metered release is 10% to 90% of initial signi?cant siZe, or as a dry poWder. The average diameter of mass value mDCI45 days to 100 days after the composition is such solid pieces of signi?cant siZe is normally at least 10 introduced into the liquid. For sloW metered release, the dis mm, preferably 15 mm, more preferably 20 mm. The average integrable composition is generally provided as one or more diameter of the particles of the poWder is normally no more solid pieces, such as tablets, of signi?cant siZe. The liquid is than 400 um, preferably no more than 300 um, more prefer normally Water, preferably high-purity Water, more prefer ably no more than 200 um. Selected amounts of the poWder of ably deioniZed Water, in one embodiment of sloW metered the disintegrable composition are commonly respectively release of the drug oftype I or II. encased With coatings to form capsules suitable for introduc [0165] In another embodiment of sloW metered release of tion into the liquid. The coatings normally disintegrate rap the medicinal drug of type I or II, the liquid is an initial liquid idly after the capsules are introduced into the liquid. In par composition prepared by dispersing a selected amount of the ticular, the coatings typically disintegrate in several minutes drug of type I or II throughout a therapeutically inactive and thus much faster than the disintegrable composition. The carrier, likeWise normally Water, preferably high-purity coatings are normally substantially chemically non-reactive