Testosterone gel and method of use
DCFirst Claim
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1. A method of treating hypogonadism in a human male in need thereof comprising the step of:
- a) applying a therapeutically effective dose of a hydroalcoholic gel to an area of skin of a human male, the hydroalcoholic gel consisting of;
i) 1.3% to 1.7% (w/w) testosterone;
ii) 0.9% to 1.0% (w/w) isopropyl myristate;
iii) 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;
iv) 0.6% to 1.4% (w/w) of a polyacrylic acid;
v) 1.0% to 10.0% (w/w) of 0.1 N sodium hydroxide; and
vi) water.
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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.
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8 Claims
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1. A method of treating hypogonadism in a human male in need thereof comprising the step of:
a) applying a therapeutically effective dose of a hydroalcoholic gel to an area of skin of a human male, the hydroalcoholic gel consisting of; i) 1.3% to 1.7% (w/w) testosterone; ii) 0.9% to 1.0% (w/w) isopropyl myristate; iii) 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;iv) 0.6% to 1.4% (w/w) of a polyacrylic acid; v) 1.0% to 10.0% (w/w) of 0.1 N sodium hydroxide; and vi) water. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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