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Claims for Patent: 8,486,925

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Claims for Patent: 8,486,925

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), Miller; Jodi (Marietta, GA)
Assignee: Unimed Pharmaceuticals, LLC (Abbott Park, IL) Laboratoires Besins International, SAS (Paris, FR)
Application Number:13/253,867
Patent Claims: 1. A hydroalcoholic gel consisting of: a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 73.5% (w/w) ethanol; d) 1.0% (w/w) of a polyacrylic acid; e) 7.0% (w/w) of 0.1 N sodium hydroxide; and f) water.

2. The hydroalcoholic gel of claim 1, wherein the ethanol is about 95% (v/v) ethanol.

3. The hydroalcoholic gel of claim 1, wherein the polyacrylic acid has been neutralized by combining 1.0% (w/w) of the polyacrylic acid with 7.0% (w/w) of the 0.1 N sodium hydroxide.

4. The hydroalcoholic gel of claim 1, wherein the polyacrylic acid is a carbomer.

5. The hydroalcoholic gel of claim 3, wherein the polyacrylic acid is a carbomer.

6. The hydroalcoholic gel of claim 1, wherein a therapeutically effective dose of the hydroalcoholic gel for treatment of hypogonadism in a human male is 2.5 grams.

7. The hydroalcoholic gel of claim 6, wherein the dose of testosterone administered by applying the therapeutically effective dose to the human male is 40.5 milligrams.
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