Topical compositions and methods of using the same

Abstract

The present invention relates generally to compositions and methods of using the same.

That which is claimed is: 
     
         1 . A method of treating acne vulgaris, the method comprising topically applying to the skin of a subject a composition comprising:
 a first viscosity increasing agent;   at least one polyhydric alcohol;   at least one buffering agent;   a second viscosity increasing agent;   at least one organic solvent;   at least one humectant;   at least one water repellent;   at least one active pharmaceutical ingredient; and   water.   
     
     
         2 . The method of  claim 1 , wherein the composition is buffered to a pH of about 3 to about 8. 
     
     
         3 . The method of  claim 1 , wherein the at least one active pharmaceutical ingredient comprises a nitric oxide-releasing active pharmaceutical ingredient. 
     
     
         4 . The method of  claim 3 , wherein the nitric oxide-releasing active pharmaceutical ingredient comprises a nitric oxide-releasing compound having a diazeniumdiolate functional group, optionally wherein the nitric oxide releasing compound comprises a NO-releasing co-condensed silica particle. 
     
     
         5 . The method of  claim 4 , wherein the nitric oxide-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 10% by weight of the composition. 
     
     
         6 . The method of  claim 4 , wherein the composition stores and/or releases nitric oxide in an amount of about 0.05% to about 3% by weight of the composition. 
     
     
         7 . The method of  claim 6 , wherein the one nitric oxide-releasing active pharmaceutical ingredient releases nitric oxide in an amount of at least about 50% over a period of time of about 3 hours or less after topical application of the composition to skin of a subject. 
     
     
         8 . The method of  claim 1 , wherein the composition comprises a first composition in admixture with a second composition, the first composition comprising:
 the at least one polyhydric alcohol in an amount of about 1% to about 30% by weight of the first composition;   the at least one viscosity increasing agent in an amount of about 0.1% to about 5% by weight of the first composition;   the at least one buffering agent in an amount of about 0.01% to about 2% by weight of the first composition; and   water in an amount of about 70% to about 99% by weight of the first composition; and   
       the second composition comprising:
 the second viscosity increasing agent in an amount of about 0.5% to about 30% by weight of the second composition; 
 at least one organic solvent in an amount of about 50% to about 90 by weight of the second composition; 
 at least one humectant in an amount of about 2% to about 20% by weight of the second composition; and 
 the at least one water repellent in an amount of about 0.5% to about 15% by weight of the second composition. 
 
     
     
         9 . The method of  claim 1 , wherein the composition is cosmetically elegant. 
     
     
         10 . The method of  claim 1 , wherein the method reduces  P. acnes  counts on the skin of the subject. 
     
     
         11 . The method of  claim 10 , wherein  P. acnes  counts are reduced by about 10% or greater over a defined period of time. 
     
     
         12 . The method of  claim 10 , wherein the reduction in  P. acnes  counts is within 12 weeks or less. 
     
     
         13 . A method of treating acne vulgaris, the method comprising:
 providing an anhydrous topical gel comprising a nitric oxide-releasing active pharmaceutical ingredient;   providing a hydrogel;   combining the anhydrous topical gel comprising the nitric oxide-releasing active pharmaceutical ingredient and the hydrogel to provide a nitric oxide-releasing topical composition; and   topically applying to the skin of a subject the nitric oxide-releasing topical composition.   
     
     
         14 . The method of  claim 13 , wherein the nitric oxide-releasing topical composition is buffered to a pH of about 3 to about 8. 
     
     
         15 . The method of  claim 13 , wherein the nitric oxide-releasing active pharmaceutical ingredient comprises a nitric oxide-releasing compound having a diazeniumdiolate functional group, optionally wherein the nitric oxide releasing compound comprises a NO-releasing co-condensed silica particle. 
     
     
         16 . The method of  claim 13 , wherein the nitric oxide-releasing active pharmaceutical ingredient is present in the composition in an amount of about 0.5% to about 10% by weight of the composition. 
     
     
         17 . The method of  claim 13 , wherein the nitric oxide-releasing topical composition stores and/or releases nitric oxide in an amount of about 0.05% to about 3% by weight of the composition. 
     
     
         18 . The method of  claim 13 , wherein the nitric oxide-releasing active pharmaceutical ingredient releases nitric oxide in an amount of at least about 50% over a period of time of about 3 hours or less after topical application of the nitric oxide-releasing topical composition to skin of a subject.