Claims for Patent: 7,608,609

Summary for Patent: 7,608,609

Title:	Pharmaceutical composition
Abstract:	A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.
Inventor(s):	Gyurik; Robert J. (Exeter, NH)
Assignee:	CPEX Pharmaceuticals, Inc. (Exeter, NH)
Application Number:	12/359,183
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,608,609
Patent Claims:	1. A method for maintaining a therapeutically effective concentration of testosterone in the blood serum of a male for treating hypogonadism which comprises transdermally delivering to the male by applying to the skin a composition which is in the form of a topical gel, which has a viscosity of about 2000 to about 6000 cps and a pH of about 4 to about 8, and comprises: (A) about 0.1 to about 5 wt. % of testosterone; (B) about 0.5 to about 15 wt. % of oxacyclohexadecan-2-one; (C) about 1 to about 6 wt. % of a thickening agent; (D) a mixture of solvents which include about 40 wt. % to about 80 wt. % of ethanol. 2. The method of claim 1 further comprising about 0.001 to about 5 wt. % of polyethylene glycol as a crystallization inhibitor. 3. The method of claim 1 wherein ethanol ranges from about 50 wt. % to about 75 wt. %. 4. The method of claim 3 wherein ethanol ranges from about 60 wt. % to about 75 wt. %. 5. The method of claim 4 further comprising propylene glycol. 6. The method of claim 5 further comprising glycerin. 7. The method of claim 1 wherein said composition is maintained on said skin for a period of time sufficient for delivery of the testosterone to the body of the male and is applied to the skin in the form of a unit dose which contains about 1 to about 300 mg of testosterone and such that, following a single application of the unit dose to the skin, the amount of circulating testosterone (AUC.sub.0-24) in the blood serum of the male achieved in the 24-hour period following the application is about 100 to about 35,000 ng.h/dL greater than the amount of circulating testosterone (AUC.sub.0-24) in the blood serum of the male than would have been achieved in the same 24-hour period had the dose not been administered. 8. A method for maintaining a therapeutically effective concentration of testosterone in the blood serum of a male for treating hypogonadism which comprises transdermally delivering to the male by applying to the skin a composition which is in the form of a topical gel, which has a viscosity of about 2000 to about 6000 cps and a pH of about 4 to about 8, and comprises: (A) about 0.1 to about 5 wt. % of testosterone; (B) about 0.5 to about 15 wt. % of oxacyclohexadecan-2-one; (C) about 1 to about 6 wt. % of a thickening agent; (D) a mixture of solvents which include about 40 wt. % to about 80 wt. % of ethanol and (E) about 0.001 to about 5 wt. % of polyethylene glycol as a crystallization inhibitor; wherein said composition is maintained on said skin for a period of time sufficient for delivery of the testosterone to the body of the male and is applied to the skin in the form of a unit dose which contains about 1 to about 300 mg of testosterone and such that, following a single application of the unit dose to the skin, the amount of circulating testosterone (AUC.sub.0-24) in the blood serum of the male achieved in the 24-hour period following the application is about 100 to about 35,000 ng.h/dL greater than the amount of circulating testosterone (AUC.sub.0-24) in the blood serum of the male than would have been achieved in the same 24-hour period had the dose not been administered. 9. The method of claim 8 wherein ethanol ranges from about 50 wt. % to about 75 wt. %. 10. The method of claim 9 wherein ethanol ranges from about 60 wt. % to about 75 wt. %. 11. The method of claim 10 further comprising propylene glycol. 12. The method of claim 11 further comprising glycerin.