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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 (Abbott Park, IL) Laboratoires Besins International, SAS (Paris, FR)|
1. A hydroalcoholic gel 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 polyacryclic acid; e) 1.0% to 10.0% (w/w) of 0.1 N sodium hydroxide; and f) water.
2. The hydroalcoholic gel of claim 1, wherein the lower alcohol is about 95% (v/v) ethanol.
3. The hydroalcoholic gel of claim 1, wherein the amount of the polyacrylic acid is 1.0% (w/w) and the amount of the 0.1 N sodium hydroxide is 7.0% (w/w), wherein the polyacrylic acid has been neutralized by combining the 1.0% (w/w) of the polyacrylic acid with the 7.0% (w/w) 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.