Novel non-aqueous topical solution of diclofenac and process for preparing the same

Abstract

The present application is at least directed to a non-aqueous topical solution. The non-aqueous topical solution includes a salt of diclofenac. The non-aqueous topical solution also includes 10 to 30% v/v of a lower chain alcohol. The non-aqueous topical solution further includes a volatile solvent. The non-aqueous topical solution still further includes 1 to 5% w/v penetration enhancer. The application also is directed to methods for preparing the non-aqueous topical solution.

What is claimed is: 
     
         1 . A non-aqueous topical solution comprising:
 a salt of diclofenac;   10 to 30% v/v of a lower chain alcohol;   a volatile solvent; and   1 to 5% w/v penetration enhancer.   
     
     
         2 . The non-aqueous topical solution of  claim 1 , wherein the volatile solvent is greater than about 50%. 
     
     
         3 . The non-aqueous topical solution of  claim 2 , wherein the volatile solvent is greater than about 60%. 
     
     
         4 . The non-aqueous topical solution of  claim 2 , wherein the volatile solvent includes one or more of propylene glycol and glycofurol. 
     
     
         5 . The non-aqueous topical solution of  claim 1 , wherein the penetration enhancer includes one or more of oleic acid, N-methyl-pyrrolidone (NMP), 2-methyl-pyrrolidone, and 1-methyl-pyrrolidone. 
     
     
         6 . The non-aqueous topical solution of  claim 1 , wherein the lower chain alcohol ranges from about 10 to 20% v/v. 
     
     
         7 . The non-aqueous topical solution of  claim 1 , wherein the lower chain alcohol has a carbon chain length of C 2  to C 5 . 
     
     
         8 . The non-aqueous topical solution of  claim 7 , wherein the lower chain alcohol includes one or more of ethanol, propanol, and isopropanol. 
     
     
         9 . A non-aqueous topical solution comprising:
 less than about 5% w/v of a salt of diclofenac;   a lower chain alcohol;   a solvent; and   1 to 5% w/v penetration enhancer.   
     
     
         10 . The non-aqueous topical solution of  claim 9 , wherein the salt of diclofenac is greater than about 1% w/v. 
     
     
         11 . The non-aqueous topical solution of  claim 9 , wherein the salt of diclofenac includes diethylamine. 
     
     
         12 . The non-aqueous topical solution of  claim 9 , wherein the lower chain alcohol has a carbon chain length of C 2  to C 5 . 
     
     
         13 . The non-aqueous topical solution of  claim 12 , wherein the lower chain alcohol includes one or more of ethanol, propanol, and isopropanol. 
     
     
         14 . The non-aqueous topical solution of  claim 9 , wherein the penetration enhancer includes one or more of oleic acid, N-methyl-pyrrolidone (NMP), 2-methyl-pyrrolidone, and 1-methyl-pyrrolidone. 
     
     
         15 . A non-aqueous topical solution comprising:
 a salt of diclofenac;   a lower chain alcohol;   a solvent greater than about 50% of the topical solution; and   1 to 5% w/v penetration enhancer.   
     
     
         16 . The non-aqueous topical solution of  claim 15 , wherein the solvent is greater than about 60%. 
     
     
         17 . The non-aqueous topical solution of  claim 16 , wherein the solvent is greater than about 75%. 
     
     
         18 . The non-aqueous topical solution of  claim 15 , wherein the salt of diclofenac is less than about 5% w/v. 
     
     
         19 . The non-aqueous topical solution of  claim 18 , wherein the salt of diclofenac is greater than about 1% w/v. 
     
     
         20 . The non-aqueous topical solution of  claim 15 , exhibiting a viscosity of about 10 to 50 cps.