摘要 |
Disclosed is a solid oral dosage form of a pharmaceutical composition which comprises: a) a therapeutically effective amount of testosterone undecanoate which is from about 0.5% w/w to about 50% w/w of the pharmaceutical composition; b) a solubilizer selected from the group consisting of a polyoxyethylenepolyoxypropylene block copolymer, a cyclodextrin, a fatty acid ester, a tocol, a tocol ester, and mixtures thereof, wherein the ratio of the solubilizer to testosterone undecanoate is from about 1: 1 w/w to about 1: 10 w/w; and c) a release modulator that is a polymeric matrix (such as a cellulose derivative, an acrylic polymer, a polyvinylpyrrolidone copolymer, shellac, polyvinyl acetate phthalate, a high molecular weight polyethylene glycol or mixtures thereof) and which is present in an amount of from 5% w/w to about 30% w/w. |