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Claims for Patent: 8,785,426

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Claims for Patent: 8,785,426

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:14/177,765
Patent Claims: 1. A pharmaceutical 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 comprises a polyol selected from 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.

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

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

4. The pharmaceutical composition of claim 1, having 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.

5. The pharmaceutical composition of claim 1 having: purified water.

6. The pharmaceutical composition of claim 1, wherein the pH-modifier is tromethamine that is present at about 0.1 weight percent.

7. A pharmaceutical composition consisting essentially of: about 0.5 to about 2 weight percent testosterone; about 75 to about 85 weight percent ethyl alcohol; about 1 to about 2 weight percent diisopropyl adipate; about 0.2 to about 0.4 weight percent methyl laurate; about 1 to about 2 weight percent oleyl alcohol; about 3 to about 7 weight percent glycerine; about 3 to about 7 weight percent propylene glycol; about 0.3 to about 0.7 weight percent polyethylene glycol; about 1 to about 3 weight percent gel-forming polymer, purified water, and about 0.1 weight percent tromethamine, wherein the weight percent is based upon the total weight of the pharmaceutical composition.

8. The pharmaceutical composition according to claim 7 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.

9. A method for transdermal delivery of testosterone to a patient, the method comprising administering to the patient a pharmaceutical composition in the form of a gel, 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 comprises a polyol selected from 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.

10. A method according to claim 9, wherein the diisopropyl adipate, methyl laurate, and oleyl alcohol are present in the cosolvent system in a ratio of (0.8-1.2) to (0.1-0.7) to 1.

11. A method according to claim 9, wherein the diisopropyl adipate, methyl laurate, and oleyl alcohol are present in the cosolvent system in a ratio of 6:1:6.

12. A method according to claim 9, further comprising applying the pharmaceutical composition to skin of the male in the form of a unit dose that contains about 25 mg to about 200 mg of testosterone.

13. A method according to claim 12, further comprising maintaining the pharmaceutical composition on the skin for a period of time sufficient for delivery of the testosterone to the male'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 male 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 male that would have been achieved in the same 24-hour period had the dose not been administered.

14. A method according to claim 9, wherein the patient has a condition associated with a deficiency of endogenous testosterone.

15. A method according to claim 9, wherein the patient is a male patient.

16. A method according to claim 15, wherein the male patient has hypogonadism.

17. A method according to claim 16, further comprising: applying the pharmaceutical composition to the male patient's skin in the form of a unit dose that contains about 25 mg to about 200 mg of testosterone; and maintaining the pharmaceutical composition on the skin for a period of time sufficient for delivery of the testosterone to the male's systemic circulation such that, following a single application of the unit dose to the skin, the amount of circulating testosterone (AUC0-24) in blood serum of the male 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 (AUC0-24) in the blood serum of the male that would have been achieved in the same 24-hour period had the dose not been administered.

18. A pharmaceutical composition according to claim 1 having about 1 weight percent testosterone.

19. A pharmaceutical composition according to claim 7 having about 1 weight percent testosterone.

20. A pharmaceutical composition according to claim 7 having about 78 weight percent ethyl alcohol.

21. A pharmaceutical composition according to claim 7 having about 1.5 weight percent diisopropyl adipate.

22. A pharmaceutical composition according to claim 7 having about 25 weight percent methyl laurate.

23. A pharmaceutical composition according to claim 7 having about 1.5 weight percent oleyl alcohol.

24. A package containing a pharmaceutical 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 comprises a polyol selected from 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.

25. A package according to claim 24 containing from 3 to 6 grams of the pharmaceutical composition.

26. A package according to claim 24 wherein the package is adapted for dispensing a single dose of the pharmaceutical composition.

27. A package according to claim 24, wherein the package is adapted for dispensing a metered volume of the pharmaceutical composition.

28. A package according to claim 27, wherein the metered volume comprises multiple doses.

29. A package according to claim 28, wherein the package is a pump.

30. A package according to claim 24, wherein the package is a pump.
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