Compositions, systems, kits, and methods for treating an infection

Abstract

Provided herein are compositions, systems, kits, and methods for treating a viral, bacterial, protozoan, and/or fungal (e.g., onychomycosis and/or tinea pedis) infection.

What is claimed: 
     
         1 . A composition comprising:
 a nitric oxide-releasing active pharmaceutical ingredient (API) comprising a diazeniumdiolate functional group;   a viscosity increasing agent present in an amount of about 0.1% to about 10% by weight of the composition,   a silicone emollient present in an amount of about 10% to about 30% by weight of the composition,   a humectant present in an amount of about 10% to about 30% by weight of the composition,   a C1-C4 alcohol present in an amount of about 1% to about 20% by weight of the composition, and   a glycol ether present in an amount of about 20% to about 40% by weight of the composition.   
     
     
         2 . The composition of  claim 1 , wherein the nitric oxide-releasing API is a diazeniumdiolate functional polysiloxane macromolecule. 
     
     
         3 . The composition of  claim 1 , wherein the composition comprises at least two different viscosity increasing agents. 
     
     
         4 . The composition of  claim 1 , wherein the emollient is present in an amount of greater than 15% and up to about 30% by weight of the composition. 
     
     
         5 . The composition of  claim 1 , wherein the C1-C4 alcohol and glycol ether are, in total, present in the composition in an amount that is less than about 50% by weight of the composition. 
     
     
         6 . The composition of  claim 1 , wherein the nitric oxide-releasing API is present in the composition in an amount of about 0.1% to about 50% by weight of the composition. 
     
     
         7 . The composition of  claim 1 , wherein the nitric oxide-releasing API comprises a NO-releasing co-condensed silica particle. 
     
     
         8 . The composition of  claim 1 , wherein the viscosity increasing agent is selected from cellulose, derivatized cellulose, hydroxypropylcellulose, alginate, metallic stearates, hydrophobic and/or hydrophilic fumed silica, silicone elastomers, silicone elastomer blends, and any combination thereof. 
     
     
         9 . The composition of  claim 1 , wherein the emollient is selected from cyclomethicone, dimethicone, simethicone, C26-28 alkyl dimethicone, C26-28 alkyl methicone, polyphenylsisquioxane, trimethylsiloxysilicate and crosspolymers of cyclopentasiloxane and dimethicone/vinyltrimethylsiloxysilicate, and any combination thereof. 
     
     
         10 . The composition of  claim 1 , wherein the humectant is a C1-C10 monoalkylene glycol. 
     
     
         11 . The composition of  claim 1 , wherein the composition is anhydrous. 
     
     
         12 . The composition of  claim 1 , wherein the composition is in the form of a gel. 
     
     
         13 . An admixture comprising
 a hydrogel; and   the composition of  claim 1 .   
     
     
         14 . The admixture of  claim 13 ,
 wherein the hydrogel comprises a thickening agent present in an amount of about 5% to about 20% by weight of the hydrogel; water present in an amount of about 50% to about 99% by weight of the hydrogel; and a buffering agent present in an amount of about 5% to about 15% by weight of the hydrogel.   
     
     
         15 . A kit comprising:
 a hydrogel; and   the composition of  claim 1 .   
     
     
         16 . The kit of  claim 15 , wherein the hydrogel comprises a thickening agent present in an amount of about 5% to about 20% by weight of the composition; water present in an amount of about 50% to about 99% by weight of the composition; and a buffering agent present in an amount of about 0.01% to about 20% by weight of the composition. 
     
     
         17 . A method of treating and/or preventing a viral, bacterial, protozoan, and/or fungal infection in and/or on a subject, the method comprising:
 administering the admixture of  claim 13  to the subject, thereby treating and/or preventing the viral, bacterial, protozoan, and/or fungal infection in and/or on the subject.   
     
     
         18 . A method of treating and/or preventing a viral, bacterial, protozoan, and/or fungal infection in and/or on a subject, the method comprising:
 administering the admixture of  claim 14  to the subject, thereby treating and/or preventing the viral, bacterial, protozoan, and/or fungal infection in and/or on the subject.   
     
     
         19 . A method of increasing the release of nitric oxide from an anhydrous topical gel comprising a diazeniumdiolate modified macromolecule, the method comprising:
 contacting the composition of  claim 1  with a hydrogel to form an admixture; and   applying the admixture to the skin of a subject.   
     
     
         20 . A method of treating and/or preventing a viral, bacterial, protozoan, and/or fungal infection in and/or on a subject, the method comprising:
 administering the admixture of  claim 13  to the subject, wherein the composition delivers a total amount of NO of at least about 50 or 100 nmol of NO/mg of the composition at about 1, 3, 5, 10, 20, 30, 40, 50, or 60 minute(s) after an initial time point as measured by in vitro release, thereby treating and/or preventing the viral, bacterial, protozoan, and/or fungal infection in and/or on the subject.