PROBLEM TO BE SOLVED: To provide an orally disintegrating sustained release tablet containing ambroxol hydrochloride.SOLUTION: An orally disintegrating sustained release tablet is manufactured by: mixing controlled-release fine particles comprising (1) core particles containing ambroxol hydrochloride and a binding agent, (2) a release-controlled layer obtained by mixing a water insoluble polymer and a water soluble polymer which covers the core particles, (3) a protecting layer which is provided outside of the release-controlled layer and contains a water soluble wax type polymer, and (4) controlled-release fine particles composed of an adhesion protecting layer which is provided outside the protecting layer and contains powder that is not dissolved and swelled in the water insoluble polymer and/or water, with quick-release fine particles obtained by covering the core particles containing ambroxol hydrochloride and the binding agent with only the water insoluble polymer or the mixture of the water insoluble polymer and the water soluble polymer so that at least part of ambroxol hydrochloride is released in the stomach and adding at least a disintegrating agent and a lubricant to the obtained mixture and then compressing and molding.COPYRIGHT: (C)2014,JPO&INPIT【課題】塩酸アンブロキソールの徐放性口腔内崩壊錠を提供する。【解決手段】(1)塩酸アンブロキソールおよび結合剤を含有するコア粒子、(2)該コア粒子を被覆する、水不溶性高分子と水溶性高分子のブレンドよりなる放出制御層、(3)放出制御層の外側の水溶性ロウ状高分子を含んでいるプロテクト層、および(4)プロテクト層の外側の、水不溶性高分子および/または水に溶解も膨潤もしない粉末を含む粘着防止層よりなる制御放出微粒子と、塩酸アンブロキソールおよび結合剤を含有するコア粒子に、少なくとも塩酸アンブロキソールの一部が胃内で放出されるように水不溶性高分子単独またはその水溶性高分子とのブレンドで被覆してなる速放性微粒子を混合し、これに少なくとも崩壊剤および滑沢剤を加えて圧縮成形し、口腔内崩壊錠を製造する。【選択図】なし
