DrugPatentWatch Database Preview
« Back to Dashboard
Summary for Patent: 8,466,138
|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)|
1. A method of treating hypogonadism in a human male in need thereof comprising the step of: applying a therapeutically effective dose of a hydroalcoholic gel to an area of
skin of a human male, the hydroalcoholic gel consisting of: i) 1.62% (w/w) testosterone; ii) 1.0% (w/w) isopropyl myristate; iii) 73.5% (w/w) ethanol; iv) 1.0% (w/w) of a polyacrylic acid; v) 7.0% (w/w) of 0.1 N sodium hydroxide; and vi) water.
2. The method of claim 1, wherein the ethanol is 95% (v/v) ethanol.
3. The method of claim 1, wherein the polyacrylic acid is has been neutralized by combining the polyacrylic acid 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 application 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 3, wherein the polyacylic acid is a carbomer.
8. The method of claim 1, wherein the therapeutically effective dose of the hydroalcoholic gel is 2.5 grams.
9. The method of claim 8, wherein the dose of the testosterone administered to the human male by the applying is 40.5 milligrams.
For more information try a trial or see the plans and pricing
Serving hundreds of leading biopharmaceutical companies globally:
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.