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Claims for Patent: 8,754,070

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Claims for Patent: 8,754,070

Title:Testosterone gel and method of use
Abstract: The present invention relates to an improved transdermal hydroalcoholic testosterone gel 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:13/831,217
Patent Claims: 1. A gel pharmaceutical composition consisting of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol; and 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.

2. The gel pharmaceutical composition of claim 1, wherein the anionic polymer is a polyacrylic acid.

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

4. 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.

5. The gel pharmaceutical composition of claim 4, wherein the neutralizer is sodium hydroxide.

6. The gel pharmaceutical composition of claim 1, which consists of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol; and d) 1.0% (w/w) of a carbomer which has been neutralized with sodium hydroxide; and e) water.

7. The gel pharmaceutical composition of claim 1, which consists of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol; and d) 1.0% (w/w) of a carbomer; e) an amount of sodium hydroxide sufficient to form a gel; and f) water.

8. 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 comprises 40.5 milligrams of testosterone.
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