Generated: May 24, 2017
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.