Nitric oxide releasing pharmaceutical compositions

Abstract

The present invention generally relates to nitric oxide releasing pharmaceutical compositions and methods of using the same.

That which is claimed is: 
     
         1 . A pharmaceutical composition for topical delivery of a moisture activated active pharmaceutical ingredient, the composition comprising:
 (a) a hydrophobic base; and   (b) an amphiphilic compound.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein
 the hydrophobic base is present in the composition at a concentration from about 35% to about 90%; and   the amphiphilic compound is present in the composition at a concentration from about 1% to about 30%.   
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the amphiphilic compound has a hydrophilic-lipophilic balance (HLB) value of 12 to 20. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the amphiphilic compound comprises a fatty acid ester. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the amphiphilic compound comprises at least one of polyethylene glycol (PEG) caprylic and capric glyceride. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the amphiphilic compound comprises a PEG-6-caprylic/capric glyceride. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the amphiphilic compound absorbs moisture and does not substantially absorb vaporous moisture. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the hydrophobic base comprises at least one of mineral oil and a hydrophobic polymer. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition further comprises a cosolvent and the cosolvent is present in the composition at a concentration from about 1% to about 30%. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the cosolvent comprises a fatty acid ester. 
     
     
         11 . The pharmaceutical composition of  claim 9 , wherein the cosolvent comprises a caprylic/capric triglyceride. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition further comprises a humectant and the humectant is present in the composition at a concentration from about 1% to about 25%. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the humectant comprises a polyhydric alcohol. 
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition further comprises a moisture activated active pharmaceutical ingredient and the moisture activated active pharmaceutical ingredient is present in the composition at a concentration from about 0.10% to about 70%. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the moisture activated active pharmaceutical ingredient comprises a nitric oxide releasing compound. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the nitric oxide releasing compound comprises a diazeniumdiolate functional group. 
     
     
         17 . The pharmaceutical composition of  claim 15 , wherein the nitric oxide releasing compound comprises a NO-releasing co-condensed silica particle. 
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the co-condensed silica particle has a mean particle size of less than about 10 μm. 
     
     
         19 . A pharmaceutical composition for topical delivery of a moisture activated active pharmaceutical ingredient, the composition comprising:
 a moisture activated active pharmaceutical ingredient present in the composition at a concentration from about 0.1% to about 35%;   a hydrophobic polymer present in the composition at a concentration from about 30% to about 60%;   a mineral oil present in the composition at a concentration from about 1% to about 30%;   an amphiphilic compound present in the composition at a concentration from about 1% to about 20%;   a cosolvent present in the composition at a concentration from about 1% to about 25%; and   a humectant present in the composition at a concentration from about 1% to about 25%.   
     
     
         20 . The pharmaceutical composition of  claim 1 , wherein the composition comprises an ointment. 
     
     
         21 . The pharmaceutical composition of  claim 1 , wherein water is present in the composition at a concentration of less than about 2%. 
     
     
         22 . A method of treating the skin of a subject, the method comprising topically administering the pharmaceutical composition of  claim 1  in an amount effective to treat the skin of a subject. 
     
     
         23 . The method of  claim 22 , further comprising contacting water to the pharmaceutical composition before, after, and/or during the step of topically administering the composition.