PROBLEM TO BE SOLVED: To provide a solid oral controlled-release formulation suitable for 24-hourly administration to a human patient.SOLUTION: A solid oral controlled-release formulation comprises a) in a pharmaceutically acceptable matrix, an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof in combination with controlled-release material or b) a plurality of inert pharmaceutically acceptable beads coated with an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof and overcoated with a controlled-release material. The formulation provides a C24/Cmax ratio of 0.55 to about 0.85 after administration to a human patient and a therapeutic effect for at least about 24 hours after administration to a human patient.COPYRIGHT: (C)2015,JPO&INPIT【課題】ヒト患者への24時間おきの投与に適する固体経口放出制御製剤の提供。【解決手段】a)製薬上許容しうるマトリックスの中に、放出制御物質と組み合わしたヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量を含むか、またはb)複数の不活性な製薬上許容しうるビーズ上にヒドロコドンまたは製薬上許容しうるその塩の鎮痛有効量をコートし、更に放出制御物質でオーバーコートしたものを含み、ヒト患者への投与後に0.55~約0.85のC24/Cmax比を有し、かつ、ヒト患者への投与後に少なくとも約24時間治療効果を有する、前記固体経口放出制御製剤。【選択図】なし
