Nitric oxide releasing nail coating compositions, nitric oxide releasing nail coatings, and methods of using the same

Abstract

The present invention relates to nitric oxide (NO)-releasing nail coating compositions, NO-releasing coatings, and methods of using the same, for example, to treat fungal infections of a nail. Provided according to embodiments of the invention are nitric oxide (NO)-releasing nail coating compositions and/or coatings. In some embodiments, a NO-releasing nail coating composition and/or coating may be in the form of a film. In some embodiments, a NO-releasing nail coating may be formed from a NO-releasing nail coating composition. In some embodiments, a NO-releasing nail coating composition may be in the form of a nail lacquer, a paste, a cream, a gel, and/or an ointment.

1 .- 37 . (canceled) 
     
     
         38 . A method of treating and/or preventing a nail disease and/or disorder in a subject, the method comprising:
 topically applying a nail coating composition to a nail of the subject, wherein the nail coating composition comprises a first component comprising a NO-releasing co-condensed silica and a second component that is a hydrogel, thereby treating and/or preventing the nail disease or disorder in the subject.   
     
     
         39 . The method of  claim 38 , wherein the first component further comprises at least one viscosity increasing agent, at least one organic solvent, and at least one humectant. 
     
     
         40 . The method of  claim 39 , wherein the at least one viscosity increasing agent is present at a concentration in a range of 0.5% to 30% by weight of the first component,
 the at least one organic solvent is present at a concentration in a range of 50% to 90% by weight of the first component,   the at least one humectant is present at a concentration in a range of 2% to 20% by weight of the first component, and   the NO-releasing co-condensed silica is present at a concentration in a range of about 0.1% to about 70% by weight percent of the first component.   
     
     
         41 . The method of  claim 38 , wherein the first component further comprises:
 hydroxypropyl cellulose at a concentration in a range of 0.1% to 15% by weight of the first component;   ethyl alcohol or isopropyl alcohol at a concentration in a range of 45% to 95% by weight of the first component;   hexylene glycol at a concentration in a range of 1% to 20% by weight of the first component;   cyclomethicone at a concentration in a range of 0.5% to 15% by weight of the first component; and   diazeniumdiolated co-condensed silica particles at a concentration in a range of 0.1% to 40% by weight of the first component.   
     
     
         42 . The method of  claim 38 , wherein the first component further comprises a hydrophobic base and an amphiphilic compound. 
     
     
         43 . The method of  claim 42 , wherein the hydrophobic base is present at a concentration from about 35% to about 90% by weight of the first component and the amphiphilic compound is present at a concentration from about 1% to about 30% by weight of the first component. 
     
     
         44 . The method of  claim 43 , wherein the amphiphilic compound is a polyethylene glycol (PEG) caprylic/capric glyceride. 
     
     
         45 . The method of  claim 38 , wherein the hydrogel comprises a first viscosity increasing agent, at least one polyhydric alcohol, at least one buffering agent, and water. 
     
     
         46 . The method of  claim 45 , wherein the hydrogel comprises the first viscosity increasing agent in an amount of 0.6% to 5% by weight of the second component and the at least one polyhydric alcohol in an amount of 1% to 30% by weight of the second component. 
     
     
         47 . The method of  claim 46 , wherein the first viscosity increasing agent is a cellulose ether or a carboxypolymethylene. 
     
     
         48 . The method of  claim 38 , wherein topically applying the nail coating composition to the nail of the subject comprises separately topically applying the first component and the second component. 
     
     
         49 . The method of  claim 38 , wherein topically applying the nail coating composition to the nail of the subject comprises combining the first component and the second component to form a combined composition and topically applying the combined composition to the nail of the subject. 
     
     
         50 . The method of  claim 38 , wherein topically applying the nail coating composition to the nail of the subject comprises topically applying the first component and second component in a ratio in a range of about 1:1 to about 1:10. 
     
     
         51 . The method of  claim 38 , wherein the nail coating composition is devoid of acidified nitrite. 
     
     
         52 . The method of  claim 38 , wherein the first component and the second component are separately stored. 
     
     
         53 . The method of  claim 38 , wherein the method has increased efficacy in treating and/or preventing the nail disease and/or disorder in the subject by at least about 5% compared to a treatment that does not apply a composition comprising a NO-releasing compound. 
     
     
         54 . The method of  claim 38 , wherein the method decreases the rate of reinfection of the nail disease and/or disorder in the subject by at least about 5% compared to a treatment that does not apply a composition comprising a NO-releasing compound. 
     
     
         55 . The method of  claim 38 , wherein the method reduces treatment duration in the subject compared to a treatment that does not apply a composition comprising a NO-releasing compound. 
     
     
         56 . The method of  claim 38 , wherein the method comprises topically applying the nail coating composition to the nail of the subject at least 1, 2, or 3 times per day. 
     
     
         57 . The method of  claim 38 , wherein the hydrogel has a pH of about 3.5 to about 6.5.