PROBLEM TO BE SOLVED: To provide a stable candesartan cilexetil-containing formulation in which generation of related substances is suppressed even if undergoing tableting process.SOLUTION: Granules for tableting are produced by spraying an active pharmaceutical ingredient dispersion liquid obtained by dispersing candesartan cilexetil in a water containing at least a binder or a hydrous ethanol, to D-mannitol granules with particle sizes in a range of 75-150 μm. An orally disintegrating tablet is produced by adding at least an excipient, a disintegrator and a lubricant to the granules for tableting and performing compression molding.COPYRIGHT: (C)2015,JPO&INPIT【課題】打錠工程を経ても類縁物質の生成が抑制される安定なカンデサルタンシレキセチル含有製剤を提供する。【解決手段】粒度範囲が75~150μmにあるD-マンニトール顆粒に、少なくとも結合剤を含む水または含水エタノールにカンデサルタンシレキセチルを分散した原薬分散液を噴霧して打錠用顆粒を製造する。この打錠用顆粒に、少なくとも賦形剤と崩壊剤と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
