HIGH-STRENGTH TESTOSTERONE UNDECANOATE COMPOSITIONS

摘要

The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.

主权项

1. A pharmaceutical composition comprising from about 14 weight % (wt %) to about 35 wt % testosterone undecanoate and a pharmaceutically acceptable carrier, said testosterone undecanoate being not fully dissolved at room temperature.