Testosterone gel and method of use
AssigneesLaboratoire Besins International, SAS, Unimed Pharmaceuticals, LLC
InventorsRamana Malladi, Jodi Stahlman
Life of this patent
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Abstract
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.
Claims34
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A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of a gel pharmaceutical composition consisting essentially 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.
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.
A method of treating hypogonadism in a human male comprising applying a therapeutically effective dose of a gel pharmaceutical composition consisting essentially of:
- a) about 1.62% (w/w) testosterone;
- b) about 1.0% (w/w) isopropyl myristate;
- c) about 68.1% (w/w) dehydrated ethanol;
- and
- d) about 1.0% (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.
Dependencies are inferred from the claim text.