US 7,320,968 B2 | ||
Pharmaceutical composition | ||
Robert J. Gyurik, Exeter, N.H. (US) | ||
Assigned to Bentley Pharmaceuticals, Inc., Exeter, N.H. (US) | ||
Appl. No. 10/473,724 PCT Filed Apr. 21, 2003, PCT No. PCT/US03/12235 § 371(c)(1), (2), (4) Date Oct. 01, 2003, PCT Pub. No. WO03/088974, PCT Pub. Date Oct. 30, 2003. |
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Claims priority of provisional application 60/374103, filed on Apr. 19, 2002. | ||
Prior Publication US 2005/0192260 A1, Sep. 01, 2005 | ||
Int. Cl. A01N 45/00 (2006.01) |
U.S. Cl. 514—169 | 4 Claims |
1. A method for maintaining an 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: (i) about 60 to about 75 wt. % of ethanol or isopropanol; and (ii) propylene glycol and glycerin as co-solvents; 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 (AUC0-24) 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 (AUC0-24) in the blood serum of the male than would have been achieved in the same 24-hour period had the dose not been administered. |