US2011201586A1PendingUtilityA1

Pharmaceutical composition and method for treating hypogonadism

Assignee: DUDLEY ROBERT EPriority: Aug 30, 2000Filed: Mar 24, 2011Published: Aug 18, 2011
Est. expiryAug 30, 2020(expired)· nominal 20-yr term from priority
A61P 5/00A61P 5/26A61P 15/08A61K 31/565A61K 47/32A61K 47/14A61K 9/0014A61K 31/568A61K 31/5685A61K 47/10A61K 9/06A61K 47/12
60
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Claims

Abstract

A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.

Claims

exact text as granted — not AI-modified
1 . A hydroalcoholic gel pharmaceutical composition, comprising:
 a. from about 0.5% to about 10% testosterone;   b. from about 30% to about 98% alcohol selected from the group consisting of ethanol and isopropanol;   c. from about 0.1% to about 5% of a thickening agent;   d. from about 0.25% to about 2.5% of at least one penetration enhancer selected from the group consisting of isostearic acid, octanoic acid, lauryl alcohol, isopropyl myristate, butyl stearate, methyl laurate, diisopropyl adipate, glyceryl monolaurate, tetrahydrofurfuryl alcohol polyethylene glycol ether, polyethylene glycol, propylene glycol, 2-(2-ethoxyethoxy)ethanol, diethylene glycol monomethyl ether, dimethyl sulfoxide, glycerol, ethyl acetate, acetoacetic ester, N-alkylpyrrolidone, derivatives thereof, and combinations thereof; and   e. water in an amount sufficient to make the composition 100%,   
       wherein the percentages of components are weight to weight of the composition. 
     
     
         2 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the testosterone is present in a concentration of from about 0.5% to about 5% (w/w) of the composition. 
     
     
         3 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the alcohol is ethanol. 
     
     
         4 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the thickening agent is an anionic polymer. 
     
     
         5 . The hydroalcoholic gel pharmaceutical composition of  claim 4 , wherein the anionic polymer is selected from the group consisting of polyacrylic acid, carboxymethyl cellulose, and combinations thereof. 
     
     
         6 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the composition further comprises 0.1N sodium hydroxide. 
     
     
         7 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises isostearic acid. 
     
     
         8 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises octanoic acid. 
     
     
         9 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises lauryl alcohol. 
     
     
         10 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises isopropyl myristate. 
     
     
         11 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises butyl stearate. 
     
     
         12 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises methyl laurate. 
     
     
         13 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises diisopropyl adipate. 
     
     
         14 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises glyceryl monolaurate. 
     
     
         15 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises tetrahydrofurfuryl alcohol polyethylene glycol ether. 
     
     
         16 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises polyethylene glycol. 
     
     
         17 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises propylene glycol. 
     
     
         18 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises 2-(2-ethoxyethoxy)ethanol. 
     
     
         19 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises diethylene glycol monomethyl ether. 
     
     
         20 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises dimethyl sulfoxide. 
     
     
         21 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises glycerol. 
     
     
         22 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises ethyl acetate. 
     
     
         23 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises acetoacetic ester. 
     
     
         24 . The hydroalcoholic gel pharmaceutical composition of  claim 1 , wherein the penetration enhancer comprises N-alkylpyrrolidone.

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