摘要 |
<p>PROBLEM TO BE SOLVED: To provide a steroid-containing delayed-release oral formulation suitable for providing therapeutically effective amounts of at least one steroid to individuals.SOLUTION: The present invention provides an oral pharmaceutical composition comprising 1-50%w/w of one or more testosterone C2-C13 alkyl ester; 1-90%w/w of a hydrophilic carrier, and/or 1-90%w/w of a lipophilic carrier; and 1-50%w/w of a coagulant. When the composition is put in a USP Type-II (paddle) apparatus with conditions at 37±0.5°C and at 100 rpm, and a release test is performed in the aqueous medium which is deionized water comprising 8% w/v of Triton X-100, the oral pharmaceutical composition releases 90% or less of the testosterone C2-C13 alkyl ester into the aqueous medium within 30 minutes.</p> |