Claims for Patent: 7,935,690

Summary for Patent: 7,935,690

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:	11/928,467
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,935,690
Patent Claims:	1. A method for maintaining a therapeutically effective concentration of an androgen in the blood serum of a male for treating of 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 500 to about 20,000 cps and a pH of about 3 to about 9, and comprises: (A) about 0.1 to about 5 wt. % of an androgen selected from the group consisting of testosterone, DHEA (dehydroepiandrosterone), pregnenolone, progesterone, 17-OH-progesterone, and androsterone; (B) about 8 to about 25 wt. % of a macrocyclic enhancer selected from the group consisting of 3-methylcyclopentadecanone, 9-cycloheptadecen-1-one, cyclohexadecanone, cyclopentadecanone, oxacyclohexadecan-2-one and mixtures thereof; and (C) about 0.1 to about 10 wt. % of a thickening agent; (D) a mixture of solvents which include about 40 wt. % to about 80% of ethanol. 2. The method of claim 1 wherein the composition further comprises polyethylene glycol. 3. The method of claim 2 wherein the polyethylene glycol is present in an amount that ranges from about 0.001 to about 5 wt. %. 4. The method of claim 1 the viscosity ranges from about 1,000 cps to about 9,000 cps. 5. The method of claim 1 wherein the viscosity ranges from about 2,000 cps to about 8,000 cps. 6. The method of claim 1 wherein the viscosity ranges from about 3,000 cps to about 7,000 cps. 7. The method of claim 1 wherein the pH ranges from about 4 to about 8. 8. The method of claim 1 wherein ethanol ranges from about 50 wt. % to about 75 wt. %. 9. The method of claim 1 wherein ethanol ranges from about 60 wt. % to about 75 wt. %. 10. The method of claim 9 further comprising propylene glycol. 11. The method of claim 10 further comprising glycerin. 12. The method of claim 1 wherein the macrocyclic enhancer is oxacyclohexadecan-2-one. 13. The method of claim 1 wherein the macrocyclic enhancer is 3-methylcyclopentadecanone. 14. The method of claim 1 wherein the macrocyclic enhancer is 9-cycloheptadecen-1-one. 15. The method of claim 1 wherein the macrocyclic enhancer is cyclohexadecanone. 16. The method of claim 1 wherein the macrocyclic enhancer is cyclopentadecanone.