Pharmaceutical composition and method for treating hypogonadism
DCFirst Claim
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1. A method of treating hypogonadism in a human male, the method comprising the steps of:
- applying, once per day, a therapeutically effective dose of a pharmaceutical composition to an area of skin of the human male, the pharmaceutical composition consisting of;
(i) 0.1% to 10% (w/w) testosterone;
(ii) 0.10% to 5.0% (w/w) isopropyl myristate;
(iii) 30.0% to 98.0% (w/w) of ethanol, isopropanol or combinations thereof;
(iv) 0.1% to 5.0% of a polyacrylic acid, wherein the polyacrylic acid is neutralized with sodium hydroxide; and
(v) water;
wherein the administration of the pharmaceutical composition is as a gel and not as part of a patch, andfurther wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 4 hours or less before returning to an approximately constant level.
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Abstract
A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.
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7 Claims
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1. A method of treating hypogonadism in a human male, the method comprising the steps of:
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applying, once per day, a therapeutically effective dose of a pharmaceutical composition to an area of skin of the human male, the pharmaceutical composition consisting of; (i) 0.1% to 10% (w/w) testosterone; (ii) 0.10% to 5.0% (w/w) isopropyl myristate; (iii) 30.0% to 98.0% (w/w) of ethanol, isopropanol or combinations thereof; (iv) 0.1% to 5.0% of a polyacrylic acid, wherein the polyacrylic acid is neutralized with sodium hydroxide; and (v) water; wherein the administration of the pharmaceutical composition is as a gel and not as part of a patch, and further wherein the administration once per day is sufficient for the testosterone to reach the bloodstream of the human male to achieve a steady state profile in which there is an increase in serum testosterone levels of the human male for a period of time of 4 hours or less before returning to an approximately constant level. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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