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|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) Laboratoires Besins International, SAS (Paris, FR)|
1. A method of treating hypogonadism in a human male in need thereof comprising the step of: a) applying a therapeutically effective dose of a hydroalcoholic gel to an area
of skin of a human male, the hydroalcoholic gel consisting of: i) 1.3% to 1.7% (w/w) testosterone; ii) 0.9% to 1.0% (w/w) isopropyl myristate; iii) 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; iv) 0.6% to 1.4% (w/w) of a polyacrylic acid; v) 1.0% to 10.0% (w/w) of 0.1 N sodium hydroxide; and vi) water.
2. The method of claim 1, wherein the lower alcohol is 95% (v/v) ethanol.
3. The method of claim 1, wherein the polyacrylic acid is a carbomer in an amount of 1.0% (w/w) and the 0.1 N sodium hydroxide is in an amount of 7.0% (w/w), wherein the carbomer has been neutralized by combining the 1.0% (w/w) of the carbomer with the 7.0% (w/w) 0.1 N sodium hydroxide.
4. The method of claim 1, wherein after the applying of the hydroalcoholic gel, the hydroalcoholic gel provides sufficient testosterone to achieve a circulating blood serum testosterone concentration in the human male of between about 298 and about 1043 ng testosterone per dl serum.
5. The method of claim 1, wherein after the applying of the hydroalcoholic gel, the serum testosterone concentration in the human male is maintained between about 300 and about 1050 ng testosterone per dl serum.
6. The method of claim 1, wherein the polyacrylic acid is a carbomer.
7. The method of claim 1, wherein the therapeutically effective dose of the hydroalcoholic gel is 2.5 grams.
8. The method of claim 7, wherein the dose of the testosterone administered to the human male by the applying is 40.5 milligrams.