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Claims for Patent: 8,759,329

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Claims for Patent: 8,759,329

Title: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.
Inventor(s): Malladi; Ramana (Marietta, GA), Stahlman; Jodi (Smyma, GA)
Assignee: Unimed Pharmaceuticals, LLC (Marietta, GA) Besins Healthcare Luxembourg SARL (Charlotte, LU)
Application Number:13/831,189
Patent Claims: 1. A gel pharmaceutical composition obtained by combining the following ingredients which consist of: a) 1.3% to 1.7% (w/w) testosterone; b) 0.9% to 1.0% (w/w) isopropyl myristate; c) 67.0% to 74.0% (w/w) of a lower alcohol selected from the group consisting of methanol, ethanol, n-propanol, and isopropanol; d) 0.6% to 1.4% (w/w) of a gelling agent which is a polyacrylic acid; e) an amount of a neutralizer of the polyacrylic acid sufficient to form a gel; and f) water.

2. The gel pharmaceutical composition of claim 1, wherein the lower alcohol is ethanol.

3. The gel pharmaceutical composition of claim 2, wherein the ethanol is absolute ethanol.

4. The gel pharmaceutical composition of claim 2, wherein the ethanol is 95% (v/v) ethanol.

5. The gel pharmaceutical composition of claim 1, wherein the polyacrylic acid is a carbomer.

6. The gel pharmaceutical composition of claim 1, wherein the neutralizer is selected from the group consisting of: sodium hydroxide, ammonium hydroxide, potassium hydroxide, arginine, aminomethyl propanol, tetrahydroxypropyl ethylenediamine, triethanolamine, tromethamine, PEG-15 cocamine, diisopropanolamine and triisopropanolamine and combinations thereof.

7. The gel pharmaceutical composition of claim 6, wherein the neutralizer is sodium hydroxide.

8. The gel pharmaceutical composition of claim 1, wherein the testosterone in the gel pharmaceutical composition is in the range of 1.50% to 1.70% (w/w) testosterone.

9. The gel pharmaceutical composition of claim 1, obtained by combining the following ingredients which consist of: a) 1.3% to 1.7% (w/w) testosterone; b) 0.9% to 1.0% (w/w) isopropyl myristate; c) 67.0% to 74.0% (w/w) of absolute ethanol; d) 0.6% to 1.4% (w/w) of a polyacrylic acid; e) an amount of sodium hydroxide sufficient to form a gel; and f) water.

10. The gel pharmaceutical composition of claim 9, wherein the amount of sodium hydroxide is in the range of 1.0% to 10% (w/w) of 0.1 N sodium hydroxide.

11. The gel pharmaceutical composition of claim 1, wherein a therapeutically effective dose of the gel pharmaceutical composition for treatment of hypogonadism in a human male subject is 2.5 grams.

12. The gel pharmaceutical composition of claim 11, wherein the therapeutically effective dose comprises 40.5 milligrams of testosterone.

13. A gel pharmaceutical composition obtained by combining the following ingredients which consist of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol or 73.5% (w/w) of 95% (v/v) of ethanol; d) 1.0% (w/w) of a gelling agent which is a polyacrylic acid; e) an amount of a neutralizer of the polyacrylic acid sufficient to form a gel, wherein the neutralizer is selected from the group consisting of: sodium hydroxide, ammonium hydroxide, potassium hydroxide, arginine, aminomethyl propanol, tetrahydroxypropyl ethylenediamine, triethanolamine, tromethamine, PEG-15 cocamine, diisopropanolamine and triisopropanolamine and combinations thereof; and f) water.

14. The gel pharmaceutical composition of claim 13, wherein the polyacrylic acid is a carbomer.

15. The gel pharmaceutical composition of claim 13, wherein the neutralizer is sodium hydroxide.

16. The gel pharmaceutical composition of claim 13, obtained by combining the following ingredients which consist of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol or 73.5% (w/w) of 95% (v/v) ethanol; d) 1.0% (w/w) of a polyacrylic acid; e) an amount of sodium hydroxide sufficient to form a gel, wherein the amount of sodium hydroxide is in the range of 1.0% to 10% (w/w) of 0.1 N sodium hydroxide; and f) water.

17. The gel pharmaceutical composition of claim 16, wherein a therapeutically effective dose of the gel pharmaceutical composition for treatment of hypogonadism in a human male comprises 40.5 milligrams of testosterone.

18. The gel pharmaceutical composition of claim 16, wherein the amount of sodium hydroxide is about 7% of 0.1 N sodium hydroxide.
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