Testosterone gel and method of use

摘要

The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.

主权项

1. A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of a gel pharmaceutical composition consisting of:
a) 1.3% to 1.7% (w/w) testosterone; b) 0.9% to 1.0% (w/w) isopropyl myristate; c) 67.0% to 74.0% (w/w) of a lower alcohol selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, sec-butanol, and tert-butanol; d) 0.6% to 1.4% (w/w) of a gelling agent, which gelling agent is an anionic polymer that has been neutralized with an amount of neutralizer sufficient to form a gel; and e) water,to an area of skin of the human male.