ORALLY RAPIDLY DISINTEGRATING TABLET

• Main Authors: NARISAWA SHINJI, OKAWA AKIKO, MORIMOTO MASAYUKI, KITAOKA KENICHI, SUGIMOTO MASAAKI
• Format: Patent
• Language: English; Japanese
• Published: 20.07.2017
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

PROBLEM TO BE SOLVED: To provide a pharmaceutical preparation containing bepotastine or a pharmacologically acceptable salt thereof in which bitter taste is masked, which has both excellent oral disintegration and sufficient hardness, and can be manufactured in ordinary tablet manufacturing facility.SOLUTION: There are provided an orally rapidly disintegrating tablet containing: bepotastine or a pharmacologically acceptable salt thereof; menthol or cyclodextrin; water-insoluble polymer; and disintegrating agent, and a method for manufacturing an orally rapidly disintegrating tablet which includes: 1) a process of mixing and granulating bepotastine or a pharmacologically acceptable salt thereof and water-insoluble polymer or the like to obtain granulated granules; 2) a process of mixing the granulated granules, menthol and disintegrating agent or the like to obtain granules for tableting; and 3) a process of compression-molding the granules for tableting.SELECTED DRAWING: None 【課題】苦味がマスキングされ、優れた口腔内崩壊性と充分な硬度を併せ持ちかつ、通常の錠剤製造設備で製造可能なベポタスチンまたはその薬理学的に許容しうる塩を含有する製剤の提供。【解決手段】ベポタスチンまたはその薬理学的に許容しうる塩；メントールまたはシクロデキストリン；水不溶性高分子；および崩壊剤を含有する口腔内速崩壊性錠；ならびに、１）ベポタスチンまたはその薬理学的に許容しうる塩および水不溶性高分子等を混合・造粒して造粒顆粒を得る工程；２）当該造粒顆粒、メントールおよび崩壊剤等を混合して打錠用顆粒を得る工程；および３）当該打錠用顆粒を圧縮成形する工程；を含む口腔内速崩壊性錠の製造方法。【選択図】なし