Testosterone gel and method of use

Abstract

The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

What is claimed is: 
     
         1 . A hydroalcoholic gel pharmaceutical composition consisting essentially of:
 a) about 1.62% (w/w) testosterone;   b) about 1.0% (w/w) isopropyl myristate;   c) about 73.5% (w/w) ethanol;   d) about 1.0% (w/w) of a neutralized thickening agent; and   e) water in an amount sufficient to make the composition 100%.   
     
     
         2 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the ethanol is about 95% (v/v) ethanol. 
     
     
         3 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the neutralized thickening agent is polyacrylic acid. 
     
     
         4 . The hydroalcoholic gel pharmaceutical composition of  claim 3 , wherein the neutralized polyacrylic acid is obtained by combining about 1.00% (w/w) of carbomer polyacrylic acid with about 7.0% (w/w) 0.1 N sodium hydroxide.