ORALLY DISINTEGRATING TABLET FORMULATION COMPRISING AMLODIPINE-CONTAINING COATED GRANULATED MATERIAL

PROBLEM TO BE SOLVED: To provide technical means for producing orally disintegrating tablet formulations of irbesartan/amlodipine besylate in which the chemical stability of drug substances in the case of storage under severe conditions, such as high temperature high humidity environment, is highly improved.SOLUTION: The present invention provides an orally disintegrating tablet containing irbesartan and amlodipine besylate, wherein a granulated material comprising amlodipine besylate is coated with a coating agent and the coating agent is a pH independent water-insoluble polymer. Preferably, the pH independent water-insoluble polymer is selected from an ethylcellulose, ethylcellulose water dispersion, and the like.SELECTED DRAWING: None 【課題】高温高湿度環境下等の過酷な条件下で保存した場合における原薬の化学的な安定性が高く改善されたイルベサルタン／アムロジピンベシル酸塩の配合口腔内崩壊錠を製造するための技術的手段を提供すること。【解決手段】イルベサルタン及びアムロジピンベシル酸塩を含み、アムロジピンベシル酸塩を含む造粒物がコーティング剤で被覆され、其のコーティング剤がｐＨ非依存性水不溶性高分子である、口腔内崩壊錠を提供する。前記のｐＨ非依存性水不溶性高分子はエチルセルロース、エチルセルロース水分散液等から選ばれることが好ましい。【選択図】なし