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Claims for Patent: 9,295,675

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Claims for Patent: 9,295,675

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)
Application Number:14/307,085
Patent Claims: 1. A pharmaceutical composition in the form of a gel, consisting essentially of: about 0.5 to about 10 weight percent testosterone; ethyl alcohol; diisopropyl adipate; methyl laurate; oleyl alcohol; glycerine; propylene glycol; polyethylene glycol polyol; gel-forming polymer; purified water; and optional pH-modifier, wherein the weight percent is based on total weight of the pharmaceutical composition.

2. A pharmaceutical composition according to claim 1 wherein the testosterone is present in a range from about 0.5 to about 2 weight percent.

3. A pharmaceutical composition according to claim 1 wherein the ethyl alcohol is present in a range from about 75 to about 85 weight percent.

4. A pharmaceutical composition according to claim 1 wherein a combination of the diisopropyl adipate, the methyl laurate and the oleyl alcohol is present in the composition in a range from about 1 to about 12 weight percent.

5. A pharmaceutical composition according to claim 1 wherein a combination of the glycerine, the propylene glycol and the polyethylene glycol polyol is present in the composition in a range from about 7 to about 14 weight percent.

6. A pharmaceutical composition according to claim 1 wherein the pH-modifier is tromethamine.

7. A pharmaceutical composition according to claim 1, wherein the gel-forming polymer is a carbomer polymer.

8. A pharmaceutical composition according to claim 1, consisting essentially of: 1 weight percent testosterone; 75 to 85 weight percent ethyl alcohol; 1 to 2 weight percent diisopropyl adipate; 0.2 to 0.4 weight percent methyl laurate; 1 to 2 weight percent oleyl alcohol; 3 to 7 weight percent glycerine; 3 to 7 weight percent propylene glycol; 0.3 to 0.7 weight percent polyethylene glycol; 1 to 3 weight percent weight percent gel-forming polymer; purified water; and pH-modifier.

9. A pharmaceutical composition according to claim 1, consisting essentially of: about 1 weight percent testosterone; about 78 weight percent ethyl alcohol; about 1.5 weight percent diisopropyl adipate; about 0.25 weight percent methyl laurate; about 1.5 weight percent oleyl alcohol; about 5 weight percent glycerine, about 5 weight percent propylene glycol, about 0.5 weight percent polyethylene glycol; 1.8 weight percent weight percent carbomer gel-forming polymer; about 4 weight percent purified water; and about 0.1 weight percent tromethamine.

10. A pharmaceutical composition according to claim 1 wherein the polyethylene glycol comprises polyethylene glycol 1000.

11. A pharmaceutical composition according to claim 1 wherein the pharmaceutical composition can be applied to skin of a patient in the form of a unit dose that contains about 25 mg to about 200 mg of testosterone, and maintained on the skin for a period of time sufficient for delivery of the testosterone to the patient's systemic circulation such that, following a single application of the unit dose to the skin, the amount of circulating testosterone (AUC.sub.0-24) in blood serum of the patient achieved in a 24-hour period following the application 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 blood serum of the patient that would have been achieved in the same 24-hour period had the dose not been administered.

12. A package containing from 3 to 6 grams pharmaceutical composition according to claim 1.

13. A package containing from 3 to 6 grams pharmaceutical composition according to claim 1, wherein the package is adapted for dispensing a single dose of the pharmaceutical composition.

14. A package containing from 3 to 6 grams pharmaceutical composition according to claim 1, wherein the package is adapted for dispensing a metered volume of the pharmaceutical composition.

15. A package according to claim 14, wherein the package comprises multiple doses.

16. A package according to claim 12, wherein the package is a pump.

17. A pharmaceutical composition according to claim 1 wherein the diisopropyl adipate, methyl laurate and oleyl alcohol are present in the composition in a ratio from (0.8:1.2) to (0.1-0.7) to 1.

18. A method of treating a condition associated with a deficiency of endogenous testosterone in a male patient, the method comprising administering to the patient a pharmaceutical composition consisting essentially of: about 0.5 to about 10 weight percent testosterone; ethyl alcohol; diisopropyl adipate; methyl laurate; oleyl alcohol; glycerine; propylene glycol; polyethylene glycol polyol; gel-forming polymer; purified water; and optional pH-modifier, wherein the weight percent is based on total weight of the pharmaceutical composition.

19. The method of claim 18, wherein the pharmaceutical composition is administered to the patient's shoulder, upper arm, axilla, upper torso, thigh, or combination thereof.

20. A package comprising multiple doses of a pharmaceutical composition, the composition consisting essentially of: about 0.5 to about 2 weight percent testosterone; about 75 to about 85 weight percent ethyl alcohol; about 2 to about 10 weight percent cosolvent system, wherein the cosolvent system consists of diisopropyl adipate, methyl laurate, and oleyl alcohol; about 7 to about 14 weight percent polyol system, wherein the polyol system consists of glycerine, propylene glycol, polyethylene glycol, and combinations thereof; about 0.5 to about 3 weight percent carbomer gel forming polymer; and pH-modifier, wherein the weight percent is based upon the total weight of the pharmaceutical composition.
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