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1. 发明公开

EP2368544A1 ORALLY RAPIDLY DISINTEGRATING TABLET, AND PROCESS FOR PRODUCING SAME 审中-公开
标题翻译： RASCH IM MUND ZERFALLENDE TABLETTE UND VERFAHREN ZU IHRER HERSTELLUNG
公开(公告)号：EP2368544A1
公开(公告)日：2011-09-28
申请号：EP09829094.3
申请日：2009-11-25
申请人： Mitsubishi Tanabe Pharma Corporation
发明人： SUGIMOTO, Masaaki , KITAOKA, Kenichi , SAITO, Yasunori , UEMURA, Katsuji
IPC分类号： A61K9/20 , A61K31/138 , A61K31/4166 , A61K31/444 , A61K31/513 , A61K31/519 , A61K47/10 , A61K47/32 , A61K47/38
CPC分类号： A61K31/138 , A61K9/0056 , A61K9/2027 , A61K9/2054 , A61K31/4166 , A61K31/444 , A61K31/513 , A61K31/519
摘要： Disclosed is an orally rapidly disintegrating tablet characterized in that the tablet can be produced in a conventional tablet manufacturing facility and has a satisfactory level of hardness for practical applications, and the change in properties of the tablet (i.e., decreased in hardness of the tablet, and delay of the disintegration time of the tablet in the oral cavity) are rarely caused by factors such as humidity. The orally rapidly disintegrating tablet has hardness of 40N or more, can be disintegrated in the oral cavity within 60 seconds, and is produced by compressing of a mixture of (a) an active ingredient, (b) an excipient having good water wettability, (c) a water-insoluble polymer that is well compactible and does not substantially cause a decrease in the water wettability of the excipient and (d) a disintegrating agent.
摘要翻译：公开了一种口服快速崩解片剂，其特征在于片剂可以在常规的片剂制造设备中制备，并且在实际应用中具有令人满意的硬度水平，并且片剂的性能变化（即，片剂的硬度降低，并且片剂在口腔中的崩解时间的延迟）很少由湿度等因素引起。口服快速崩解片剂的硬度为40N以上，可以在60秒内在口腔内分解，通过压缩（a）活性成分，（b）具有良好的水润湿性的赋形剂（ c）非常可压缩并且基本上不引起赋形剂的水润湿性降低的水不溶性聚合物和（d）崩解剂。

2. 发明公开

EP2702995A1 RAPIDLY DISSOLVING ORAL TABLET 审中-公开
标题翻译：快速溶解口服片剂
公开(公告)号：EP2702995A1
公开(公告)日：2014-03-05
申请号：EP12777027.9
申请日：2012-04-20
申请人： Mitsubishi Tanabe Pharma Corporation
发明人： NARISAWA, Shinji , SUGIMOTO, Masaaki , KITAOKA, Kenichi , OOKAWA, Akiko , MORIMOTO, Masayuki
IPC分类号： A61K31/4545 , A61K9/20 , A61K47/10 , A61K47/26 , A61K47/32 , A61K47/36 , A61K47/38 , A61K47/40
CPC分类号： A61K47/40 , A61K9/0056 , A61K9/2013 , A61K9/2018 , A61K9/205 , A61K9/2054 , A61K9/5042 , A61K31/4545 , A61K47/10
摘要： Provided is an orally disintegrating tablet comprising a bitter-tasting pharmaceutically active ingredient in the form of bepotastine or a pharmacologically acceptable salt thereof that enables the bitter taste thereof to be masked, has both superior oral cavity disintegration and adequate hardness, and can be produced with ordinary tablet production equipment. The present invention relates to an orally disintegrating tablet containing bepotastine or a pharmacologically acceptable salt thereof, menthol or cyclodextrin, a water-insoluble polymer, and a disintegrating agent; and a method for producing an orally disintegrating tablet, comprising: 1) a step for obtaining granulated granules by mixing and granulating bepotastine or a pharmacologically acceptable salt thereof, a water-insoluble polymer, and optionally a vehicle, 2) a step for obtaining granules for tableting by mixing the granulated granules, menthol, a disintegrating agent, and optionally a lubricant and/or sweetener, and 3) a step for compressing the granules for tableting.
摘要翻译：本发明提供一种口腔崩解片剂，其含有贝他斯汀或其药理学上可接受的盐形式的苦味药物活性成分，其能够掩盖苦味，具有优异的口腔崩解性和适当的硬度，并且可以用普通片剂生产设备。本发明涉及含有贝他斯汀或其药理学上可接受的盐，薄荷醇或环糊精，水不溶性聚合物和崩解剂的口腔崩解片剂; 以及制备口腔崩解片的方法，其包括：1）通过将贝他斯汀或其药理学上可接受的盐，水不溶性聚合物和任选的载体混合造粒以获得造粒颗粒的步骤，2）获得颗粒用于通过混合造粒颗粒，薄荷醇，崩解剂和任选的润滑剂和/或甜味剂进行压片，以及3）压制用于压片的颗粒的步骤。

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