Testosterone gel and method of use
DCFirst Claim
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1. A gel pharmaceutical composition obtained by combining the following ingredients which consist 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, and isopropanol;
d) 0.6% to 1.4% (w/w) of a gelling agent which is a polyacrylic acid;
e) an amount of a neutralizer of the polyacrylic acid sufficient to form a gel; and
f) 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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18 Claims
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1. A gel pharmaceutical composition obtained by combining the following ingredients which consist of:
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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, and isopropanol; d) 0.6% to 1.4% (w/w) of a gelling agent which is a polyacrylic acid; e) an amount of a neutralizer of the polyacrylic acid sufficient to form a gel; and f) water. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A gel pharmaceutical composition obtained by combining the following ingredients which consist of:
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a) 1.62% (w/w) testosterone; b) 1.0% (w/w) isopropyl myristate; c) 68.1% (w/w) absolute ethanol or 73.5% (w/w) of 95% (v/v) of ethanol; d) 1.0% (w/w) of a gelling agent which is a polyacrylic acid; e) an amount of a neutralizer of the polyacrylic acid sufficient to form a gel, wherein the neutralizer is selected from the group consisting of;
sodium hydroxide, ammonium hydroxide, potassium hydroxide, arginine, aminomethyl propanol, tetrahydroxypropyl ethylenediamine, triethanolamine, tromethamine, PEG-15 cocamine, diisopropanolamine and triisopropanolamine and combinations thereof; andf) water. - View Dependent Claims (14, 15, 16, 17, 18)
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Specification