Testosterone gel compositions and related methods
AssigneeUpsher-Smith Laboratories, Inc.
InventorHarish K. Pimplaskar
Life of this patent
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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.
Claims30
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.
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.
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.
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.
Dependencies are inferred from the claim text.