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Pharmaceutical composition

DC CAFC
  • US 7,320,968 B2
  • Filed: 04/21/2003
  • Issued: 01/22/2008
  • Est. Priority Date: 04/19/2002
  • Status: Active Grant
First Claim
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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.

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