経口テストステロンエステル配合剤およびそれを含むテストステロン欠損を処置する方法

摘要

PROBLEM TO BE SOLVED: To provide an oral formulation of a testosterone ester, which provides optimum serum testosterone levels that are clinically effective to treat hypogonadal men over an extended period of time.SOLUTION: An oral pharmaceutical composition comprises testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant in a total lipophilic surfactant to total hydrophilic surfactant ratio (w/w) falling in the range of about 6:1 to 3.5:1. Upon once- or twice-daily oral administration, the composition provides an average serum testosterone concentration at a steady state falling in the range of about 300 to about 1100 ng/dL.SELECTED DRAWING: None