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Generated: November 24, 2017

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Claims for Patent: 8,729,057

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Claims for Patent: 8,729,057

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 (Smyrna, GA)
Assignee: Unimed Pharmaeuticals, LLC (Marietta, GA) Besins Healthcare Luxembourg SARL (Charlotte, LU)
Application Number:13/831,207
Patent Claims: 1. A gel pharmaceutical composition consisting 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, isopropanol, n-butanol, isobutanol, sec-butanol, and tert-butanol; d) 0.6% to 1.4% (w/w) of a gelling agent, which gelling agent is an anionic polymer that has been neutralized with an amount of neutralizer sufficient to form a gel; and e) 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 anionic polymer is a polyacrylic acid.

6. The gel pharmaceutical composition of claim 1, wherein the anionic polymer is a carbomer.

7. 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.

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

9. 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.

10. The gel pharmaceutical composition of claim 1, which consists 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 carbomer which has been neutralized with sodium hydroxide; and e) water.

11. The gel pharmaceutical composition of claim 1, which consists 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 carbomer; e) an amount of sodium hydroxide sufficient to form a gel; and f) water.

12. The gel pharmaceutical composition of claim 11, wherein the amount of sodium hydroxide is in the range of 1.0% to 10% (w/w) of 0.1 N sodium hydroxide.

13. 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.

14. The gel pharmaceutical composition of claim 13, wherein the therapeutically effective dose comprises 40.5 milligrams of testosterone.
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