PHARMACEUTICAL COMPOSITION

  • US 20090118251A1
  • Filed: 01/23/2009
  • Published: 05/07/2009
  • Est. Priority Date: 04/19/2002
  • Status: Active Grant
First Claim
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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 0.01 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;

    (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.

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