|Title:||Pharmaceutical composition and method for treating hypogonadism|
|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.|
|Inventor(s):||Dudley; Robert E. (Kenilworth, IL), Drouin; Dominique (Verrieres le Buisson, FR)|
|Assignee:||BESINS HEALTHCARE INC. (Herndon, VA) UNIMED PHARMACEUTICALS, LLC (Abbott Park, IL)|
1. A method of administering testosterone to human males for treating hypogonadism, the method comprising the step of: administering once per day a therapeutically
effective dose of a pharmaceutical composition to human males, 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 is sufficient for the testosterone to reach the bloodstream of the human males to
achieve a steady state pharmacokinetic profile similar to the pharmacokinetic profile for a testosterone gel shown in FIG. 5c, further wherein the administration of the pharmaceutical composition results in continuous transdermal delivery of testosterone
for at least 24 hours, and still further wherein the administration of the pharmaceutical composition is as a gel and not as part of a patch.
2. The method of claim 1, wherein the sodium hydroxide is 0.1 N NaOH.
3. The method of claim 1, wherein the composition consists of testosterone, isopropyl myristate, ethanol, polyacrylic acid neutralized with sodium hydroxide and water.
4. The method of claim 3, wherein the ethanol is 95% (v/v) ethanol.