You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for Patent: 9,132,089


✉ Email this page to a colleague

« Back to Dashboard


Title:Pharmaceutical composition and method for treating hypogonadism
Abstract: A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.
Inventor(s): Dudley; Robert E. (Kenilworth, IL), Drouin; Dominique (Verrieres le Buisson, FR)
Assignee: BESINS HEALTHCARE INC. (Herndon, VA) UNIMED PHARMACEUTICALS, LLC (Abbott Park, IL)
Filing Date:Jul 15, 2013
Application Number:13/942,245
Claims:1. A method of treating hypogonadism in a human male, the method comprising the steps of: applying, once per day, a therapeutically effective dose of a pharmaceutical composition to an area of skin of the human male, the pharmaceutical composition consisting of: (i) 0.1% to 10% (w/w) testosterone; (ii) 0.10% to 5.0% (w/w) isopropyl myristate; (iii) 30.0% to 98.0% (w/w) of ethanol, isopropanol or combinations thereof; (iv) 0.1% to 5.0% of a polyacrylic acid, wherein the polyacrylic acid is neutralized with sodium hydroxide; and (v) water; wherein the administration of the pharmaceutical composition is as a gel and not as part of a patch, and further wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 4 hours or less before returning to an approximately constant level.

2. The method of claim 1, wherein the sodium hydroxide is 0.1 N NaOH.

3. The method of claim 1, wherein the composition consists of testosterone, isopropyl myristate, ethanol, polyacrylic acid neutralized with sodium hydroxide and water.

4. The method of claim 3, wherein the ethanol is 95% (v/v) ethanol.

5. The method of claim 1, wherein the hypogonadism is primary hypogonadism, secondary hypogonadism or age-related hypogonadism.

6. The method of claim 1, wherein the pharmaceutical composition is administered to the left upper arm, the right upper arm, the left shoulder or the right shoulder.

7. The method of claim 1, wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 2 hours or less before returning to a relatively constant level.

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.