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

Last Updated: April 10, 2024

Details for Patent: 9,662,340


✉ Email this page to a colleague

« Back to Dashboard


Title:Testosterone gel compositions and related methods
Abstract: Described are gel compositions containing active pharmaceutical ingredient such as testosterone, solvent, and thickener, the gel compositions being useful for transdermal administration of the active ingredient to a patient, and related methods. Certain embodiments of the gel composition specifically exclude Hsieh enhancer.
Inventor(s): Pimplaskar; Harish K. (Charlotte, NC)
Assignee: UPSHER-SMITH LABORATORIES, INC. (Maple Grove, MN)
Filing Date:Mar 25, 2016
Application Number:15/081,402
Claims:1. A method for treating hypogonadism in a patient, the method comprising applying a pharmaceutical gel composition on a patient's skin, wherein the composition comprises: about 0.5 to about 10 weight percent testosterone; lower alcohol; cosolvent system consisting essentially of diisopropyl adipate, methyl laurate, and oleyl alcohol, and being present in an amount in a range from about 2 to about 10 weight percent; polyol system being present in an amount in a range from about 7 to about 14 weight percent; gel-forming polymer; purified water; and optional pH-modifier; wherein the weight percent is based on total weight of the pharmaceutical gel composition.

2. The method of claim 1, wherein the lower alcohol consists essentially of ethanol, isopropanol, or a combination thereof.

3. The method of claim 1, wherein the composition comprises about 0.5 to about 2 weight percent testosterone.

4. The method of claim 1, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from (0.8-1.2) to (0.1-0.7) to 1.

5. The method of claim 1, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from 6:1:6.

6. The method of claim 1, wherein the polyol system consists essentially of glycerine, propylene glycol, and polyethylene glycol.

7. The method of claim 1, wherein the polyol system consists essentially of about 3 to about 7 weight percent glycerine, about 3 to about 7 weight percent propylene glycol, and about 0.3 to about 0.7 weight percent polyethylene glycol, based on total weight of the pharmaceutical gel composition.

8. The method of claim 1, wherein the composition excludes a Hseih enhancer.

9. The method of claim 1, wherein the composition excludes isopropyl myristate.

10. The method or claim 1, wherein the composition consists essentially of: about 0.5 to about 5 weight percent testosterone; from about 75 to about 85 weight percent ethyl alcohol; from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol, about 7 to about 14 weight percent polyol system; gel-forming polymer; purified water; and optional pH-modifier, based on total weight of the pharmaceutical gel composition.

11. The method or claim 1, wherein the composition consists essentially of: about 0.5 to about 10 weight percent testosterone; from about 75 to about 85 weight percent ethyl alcohol; cosolvent system consisting of from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol, about 7 to about 14 weight percent polyol system consisting of glycerine, propylene glycol, and polyethylene glycol; gel-forming polymer; purified water; and optional pH-modifier, based on total weight of the pharmaceutical gel composition.

12. The method of claim 1, further comprising maintaining the composition on the skin for period of time sufficient to deliver an amount of circulating testosterone (AUC.sub.0-24) to the patient's blood stream in a 24-hour period following the application that is about 46,000 to about 95,000 pgh/mL (picogram-hour/milliliter) greater than the amount of circulating testosterone (AUC.sub.0-24) in the patient's blood serum achieved in the same 24-hour period without the application.

13. The method of claim 1, wherein the patient's skin is selected from shoulder, upper arm, axilla, upper torso, thigh, or a combination thereof.

14. A pharmaceutical gel composition comprising: about 0.5 to about 10 weight percent testosterone; lower alcohol; cosolvent system consisting essentially of diisopropyl adipate, methyl laurate, and oleyl alcohol, and being present in an amount in a range from about 2 to about 10 weight percent; polyol system being present in an amount in a range from about 7 to about 14 weight percent; gel-forming polymer; purified water; and optional pH-modifier; wherein the weight percent is based on total weight of the pharmaceutical gel composition.

15. The pharmaceutical composition of claim 14, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from (0.8-1.2) to (0.1-0.7) to 1.

16. The pharmaceutical composition of claim 14, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol in a ratio from 6:1:6.

17. The pharmaceutical composition of claim 14, wherein the polyol system consists essentially of about 3 to about 7 weight percent glycerine, about 3 to about 7 weight percent propylene glycol, and about 0.3 to about 0.7 weight percent polyethylene glycol, based on total weight of the pharmaceutical gel composition.

18. The pharmaceutical composition of claim 14, wherein the composition consists essentially of: about 0.5 to about 5 weight percent testosterone; from about 75 to about 85 weight percent ethyl alcohol; from about 2 to about 10 weight percent cosolvent system consisting of diisopropyl adipate, methyl laurate, and oleyl alcohol; about 7 to about 14 weight percent polyol system consisting of glycerine, propylene glycol, and polyethylene glycol; gel-forming polymer; purified water; and optional pH-modifier; based on total weight of the pharmaceutical gel composition.

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.