Details for Patent: 7,608,606
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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) |
Filing Date: | Jan 20, 2009 |
Application Number: | 12/356,515 |
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 25 wt. % of oxacyclohexadecan-2-one; (C) about 1 to about 6 wt. % of a thickening agent; (D) a mixture of solvents which include: (i) about 60 to about 75 wt. % of ethanol or isopropanol; and (ii) propylene glycol and glycerin as co-solvents. 2. 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 ngh/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. 3. The method of claim 2 wherein the composition further comprises polyethylene glycol. 4. The method of claim 3 wherein the polyethylene glycol ranges from about 0.001 to about 5 wt. %. 5. The method of claim 1 wherein the oxacyclohexadecan-2-one present in said composition is in an amount of about 0.5 to about 15 wt. %. 6. The method of claim 5 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 ngh/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. 7. The method of claim 5 wherein the composition further comprises polyethylene glycol. 8. The method of claim 7 wherein the polyethylene glycol ranges from about 0.001 to about 5 wt. %. |