US2013261097A1PendingUtilityA1

Pharmaceutical composition and method for treating hypogonadism

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Assignee: DUDLEY ROBERT EPriority: Aug 30, 2000Filed: May 24, 2013Published: Oct 3, 2013
Est. expiryAug 30, 2020(expired)· nominal 20-yr term from priority
A61P 5/00A61P 5/26A61P 15/08A61K 9/06A61K 47/14A61K 31/565A61K 47/12A61K 9/0014A61K 31/5685A61K 31/568A61K 47/10A61K 47/32
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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 .- 73 . (canceled) 
     
     
         74 . A gel pharmaceutical composition comprising:
 a) about 0.1% to about 10.0% (w/w) testosterone;   b) about 30.0% to about 98.0% (w/w) ethanol;   c) about 0.1% to about 5.0% (w/w) isopropyl myristate;   d) about 0.1% to about 5.0% (w/w) of an anionic polymer neutralized with an amount of sodium hydroxide; and   e) water.   
     
     
         75 . The pharmaceutical composition of  claim 74 , wherein the anionic polymer is a polyacrylic acid. 
     
     
         76 . The gel pharmaceutical composition of  claim 75 , wherein the polyacrylic acid is a carbopol. 
     
     
         77 . The gel pharmaceutical composition of  claim 74 , wherein the sodium hydroxide is 0.1 N NaOH and the anionic polymer is a carbopol. 
     
     
         78 . The gel pharmaceutical composition of  claim 74 , wherein the ethanol is 95% (v/v) ethanol. 
     
     
         79 . A gel pharmaceutical composition consisting essentially of:
 a) about 0.1% to about 10.0% (w/w) testosterone;   b) about 30.0% to about 98.0% (w/w) ethanol;   c) about 0.1% to about 5.0% (w/w) isopropyl myristate;   d) about 0.1% to about 5.0% (w/w) of an anionic polymer neutralized with an amount of sodium hydroxide; and   e) water.   
     
     
         80 . The pharmaceutical composition of  claim 79 , wherein the anionic polymer is a polyacrylic acid. 
     
     
         81 . The gel pharmaceutical composition of  claim 80 , wherein the polyacrylic acid is a carbopol. 
     
     
         82 . The gel pharmaceutical composition of  claim 79 , wherein the sodium hydroxide is 0.1 N NaOH and the anionic polymer is a carbopol. 
     
     
         83 . The gel pharmaceutical composition of  claim 79 , wherein the ethanol is 95% (v/v) ethanol. 
     
     
         84 . A gel pharmaceutical composition that is obtained by combining the following:
 a) about 0.1% to about 10.0% (w/w) testosterone;   b) about 30.0% to about 98.0% (w/w) ethanol;   c) about 0.1% to about 5.0% (w/w) isopropyl myristate;   d) about 0.1% to about 5.0% (w/w) of a thickener that is an anionic polymer;   e) an amount of sodium hydroxide sufficient to form a gel; and   f) water.   
     
     
         85 . The gel pharmaceutical composition of  claim 84 , wherein the sodium hydroxide is 0.1 N NaOH. 
     
     
         86 . The pharmaceutical composition of  claim 84 , wherein the anionic polymer is a polyacrylic acid. 
     
     
         87 . The gel pharmaceutical composition of  claim 86 , wherein the polyacrylic acid is a carbopol. 
     
     
         88 . The gel pharmaceutical composition of  claim 84 , wherein the sodium hydroxide is 0.1 N NaOH and the anionic polymer is a carbopol. 
     
     
         89 . The gel pharmaceutical composition of  claim 84 , wherein the ethanol is 95% v/v ethanol. 
     
     
         90 . A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of a gel pharmaceutical composition to an area of skin of the human male, the composition comprising:
 a) about 0.1% to about 10.0% (w/w) testosterone;   b) about 30.0% to about 98.0% (w/w) ethanol;   c) about 0.1% to about 5.0% (w/w) isopropyl myristate;   d about 0.1% to about 5.0% (w/w) of an anionic polymer neutralized with an amount of sodium hydroxide; and   e) water.   
     
     
         91 . The method of  claim 90 , wherein the anionic polymer is a polyacrylic acid. 
     
     
         92 . The method of  claim 91 , wherein the polyacrylic acid is a carbopol. 
     
     
         93 . The method of  claim 90 , wherein the sodium hydroxide is 0.1 N NaOH and the anionic polymer is a carbopol. 
     
     
         94 . The method of  claim 90 , wherein the ethanol is 95% (v/v) ethanol.

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