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Claims for Patent: 8,741,881

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Claims for Patent: 8,741,881

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 Pharmaceuticals, LLC (Marietta, GA) Besins Healthcare Luxembourg, SARL (Charlotte, LU)
Application Number:13/831,231
Patent Claims: 1. A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of 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, to an area of skin of the human male.

2. The method of claim 1, wherein the lower alcohol is ethanol.

3. The method of claim 2, wherein the ethanol is absolute ethanol.

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

5. The method of claim 1, wherein the anionic polymer is a carbomer.

6. The method 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 method of claim 6, wherein the neutralizer is sodium hydroxide.

8. The method 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 method of claim 1, wherein the gel pharmaceutical composition 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.

10. The method of claim 1, wherein the gel pharmaceutical composition 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.

11. The method of claim 1, wherein the therapeutically effective dose of the gel pharmaceutical composition is 2.5 grams.

12. The method of claim 11, wherein the amount of testosterone applied in the applying step is 40.5 milligrams.

13. The method of claim 1, wherein a circulating serum concentration of testosterone greater than about 300 ng per dl serum is achieved in the human male during a time period beginning about 0.5 hours after said applying and ending about 24 hours after said applying.

14. A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of a gel pharmaceutical composition consisting of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) dehydrated ethanol; d) 1.0% (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 to an area of skin of the human male.

15. The method of claim 14, wherein the gel pharmaceutical composition consists of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol; d) 1.0% (w/w) of a carbomer which has been neutralized with sodium hydroxide; and e) water.

16. The method of claim 14, wherein the gel pharmaceutical composition consists of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol; d) 1.0% (w/w) of a carbomer; e) an amount of sodium hydroxide sufficient to form a gel; and f) water.

17. The method of claim 14, wherein the amount of testosterone applied in the applying step is 40.5 milligrams.

18. The method of claim 14, wherein the ethanol is 95% (v/v) ethanol.

19. The method of claim 14, wherein the anionic polymer is a carbomer.

20. The method of claim 14, 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.

21. The method of claim 20, wherein the neutralizer is sodium hydroxide.

22. The method of claim 14, wherein the therapeutically effective dose of the gel pharmaceutical composition is 2.5 grams.

23. The method of claim 14, wherein a circulating serum concentration of testosterone greater than about 300 ng per dl serum is achieved in the human male during a time period beginning about 0.5 hours after said applying and ending about 24 hours after said applying.

24. The method of claim 15, wherein the therapeutically effective dose of the gel pharmaceutical composition is 2.5 grams.

25. The method of claim 24, wherein the amount of testosterone applied in the applying step is 40.5 milligrams.

26. The method of claim 15, wherein a circulating serum concentration of testosterone greater than about 300 ng per dl serum is achieved in the human male during a time period beginning about 0.5 hours after said applying and ending about 24 hours after said applying.

27. The method of claim 16, wherein the therapeutically effective dose of the gel pharmaceutical composition is 2.5 grams.

28. The method of claim 26, wherein the amount of testosterone applied in the applying step is 40.5 milligrams.

29. The method of claim 16, wherein a circulating serum concentration of testosterone greater than about 300 ng per dl serum is achieved in the human male during a time period beginning about 0.5 hours after said applying and ending about 24 hours after said applying.
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