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1. 发明公开

EP2698159A1 PITAVASTATIN-CONTAINING PREPARATION AND METHOD FOR PRODUCING SAME 审中-公开
标题翻译： PITAVASTATINHALTIGES制备及其制造方法
公开(公告)号：EP2698159A1
公开(公告)日：2014-02-19
申请号：EP12770994.7
申请日：2012-04-10
申请人： Sawai Pharmaceutical Co., Ltd.
发明人： HAMAGUCHI, Nobuko , HOSAKA, Shouichi , NOZAWA, Kenji , OKAMURA, Yasufumi
IPC分类号： A61K31/47 , A61K47/02 , A61P3/06
CPC分类号： A61K47/02 , A61K9/2009 , A61K31/47
摘要： The present invention provides: a pitavastatin-containing preparation, which is characterized by containing pitavastatin or a pharmacologically acceptable salt thereof and at least one basic additive selected from the group consisting of basic magnesium compounds and basic calcium compounds, and which is also characterized in that an aqueous solution or aqueous dispersion thereof has a pH of more than 8 but 10 or less; and a method for producing a pitavastatin-containing preparation, which is characterized in that the above-described specific basic additive is blended with pitavastatin or a pharmacologically acceptable salt thereof so that an aqueous solution or aqueous dispersion thereof has a pH of more than 8 but 10 or less.

2. 发明公开

EP2522348A1 ATROVASTATIN-CONTAINING COATED PREPARATION 有权
标题翻译：含阿托伐他汀的包衣制剂
公开(公告)号：EP2522348A1
公开(公告)日：2012-11-14
申请号：EP10839079.0
申请日：2010-11-08
申请人： Sawai Pharmaceutical Co., Ltd.
发明人： YANAGI, Toshihiro , NOZAWA, Kenji , MAEDA, Kazuaki , TAKADA, Shinya , OKAMURA, Yasufumi
IPC分类号： A61K31/40 , A61K9/32 , A61K47/32 , A61P3/06
CPC分类号： A61K9/284 , A61K31/40
摘要： An atrovastatin-containing coated preparation characterized by comprising a solid material comprising atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt and a coating agent comprising a poly(vinyl alcohol) copolymer, wherein the solid material is coated with the coating agent; and a method for preventing the production of an analogue of atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt and a method for stabilizing atrovastatin, a pharmacologically acceptable salt thereof or a solvate of atrovastatin or the pharmacologically acceptable salt, each of which is characterized by coating the solid material with a coating agent comprising a poly(vinyl alcohol) copolymer.
摘要翻译：一种含阿托伐他汀的包衣制剂，其特征在于包含含有阿托伐他汀，其药理学上可接受的盐或阿托伐他汀的溶剂化物或其药理学上可接受的盐的固体物质和包含聚（乙烯醇）共聚物的包衣剂，其中所述固体物质用涂层剂; 以及预防阿托伐他汀类似物，其药理学上可接受的盐或阿托伐他汀溶剂化物或其药理学上可接受的盐的生成方法以及阿托伐他汀及其药理学上可接受的盐或阿托伐他汀或其药理学上可接受的盐的溶剂化物的稳定化方法其每一个的特征在于用包含聚（乙烯醇）共聚物的涂布剂涂布固体材料。

3. 发明公开

EP2308483A1 PROCESS FOR PRODUCTION OF SPHERICAL MICROPARTICLES COMPRISING TAMSULOSIN HYDROCHLORIDE 审中-公开
标题翻译： PROCESS FOR球形颗粒MICRO盐酸坦索罗辛THE PRODUCTION
公开(公告)号：EP2308483A1
公开(公告)日：2011-04-13
申请号：EP09773152.5
申请日：2009-06-29
申请人： Sawai Pharmaceutical Co., Ltd.
发明人： YANAGI, Toshihiro , IWAKURA, Yoshitaka , SANGAWA, Hisaya , OKAMURA, Yasufumi
IPC分类号： A61K31/18 , A61K9/14 , A61K9/20 , A61K9/50 , A61K47/38
CPC分类号： A61K9/5005 , A61K9/0056 , A61K9/1652 , A61K9/2054 , A61K9/2077 , A61K9/2081 , A61K31/18
摘要： Disclosed are: a process for producing spherical microparticles comprising tamsulosin hydrochloride; spherical microparticles produced by the process; coated microparticles produced by coating the spherical microparticles; and an orally disintegrating tablet comprising the coated microparticles. The process comprises the following steps (1) to (3): (1) mixing/stirring tamsulosin hydrochloride (a), microcrystalline cellulose (b) and water together until water is penetrated into the mixture of the components (a) and (b) homogeneously; (2) granulating the mixture produced in step (1) into granules by using a rotating granulator in which the peripheral speed is set to 5.5 to 9.0 m/s; and (3) drying the granules produced in step (2).
摘要翻译：公开的是：制造球形微粒，其包括盐酸坦索罗辛的方法; 通过该方法制备的球形微粒; 通过涂覆球状微粒子产生包被的微粒; 和口腔内崩解片剂，其包含经涂覆的微粒。该过程包括以下步骤（1）至（3）：（1）混合/搅拌坦洛新盐酸盐（a）中，微晶纤维素（b）和水，直到水一起渗透到各组分的混合物（a）和（b ）均匀; （2）通过使用旋转制粒机，其中所述的圆周速度被设定为5.5至造粒在步骤（1）中产生的混合物制成颗粒9.0米/秒; 和（3）干燥步骤（2）中产生的颗粒。

4. 发明公开

EP2233129A1 ORAL CAVITY DISINTEGRATING TABLET AND METHOD OF PRODUCING THE SAME 有权
标题翻译：在DERMUNDHÖHLEZERFALLENDE TABLETTE UND VERFAHREN ZU IHRER HERSTELLUNG
公开(公告)号：EP2233129A1
公开(公告)日：2010-09-29
申请号：EP08868222.4
申请日：2008-12-26
申请人： Sawai Pharmaceutical Co., Ltd.
发明人： OKUMURA, Tomonori , HAMAGUCHI, Nobuko , OKAMURA, Yasufumi
IPC分类号： A61K9/20 , A61K31/4422 , A61K47/10 , A61K47/26 , A61K47/38 , A61P9/12
CPC分类号： A61K31/4422 , A61K9/0056 , A61K9/2018 , A61K9/2054 , A61K9/2095
摘要： The present invention provides an orally disintegrating tablet which is rapidly disintegrated in an oral cavity, is easily produced, has desired appropriate hardness, and is superior in storage stability, and a production method thereof.
An orally disintegrating tablet containing (a) one or more saccharides or sugar alcohols selected from the group consisting of mannitol, lactose, xylitol, sucrose, erythritol and glucose and (b) low substituted hydroxypropylcellulose and substantially free of a starch disintegrant, which tablet is produced by steps of granulating a composition containing the above-mentioned components (a) and (b) by an agitation granulation method, and compression-molding the obtained granulation product. A method of producing an orally disintegrating tablet substantially free of a starch disintegrant, including steps of granulating a composition containing the above-mentioned components by an agitation granulation method, and compression-molding the obtained granulation product.
摘要翻译：本发明提供一种口腔崩解片剂，其在口腔内快速崩解，容易制造，具有所需适当的硬度，且储存稳定性优异，且其制备方法。一种口服崩解片，其含有（a）一种或多种选自甘露糖醇，乳糖，木糖醇，蔗糖，赤藓糖醇和葡萄糖的糖或糖醇，和（b）低取代羟丙基纤维素，基本上不含淀粉崩解剂，通过使用搅拌造粒法将含有上述成分（a）和（b）的组合物成粒的工序来制造，对所得造粒物进行压缩成型。一种生产基本上不含淀粉崩解剂的口腔崩解片剂的方法，包括通过搅拌造粒法将含有上述组分的组合物制粒的步骤，并将所得制粒产品压缩成型。

5. 发明授权

EP2522348B1 ATORVASTATIN-CONTAINING COATED PREPARATION 有权
标题翻译：含阿托伐他汀的包衣制剂
公开(公告)号：EP2522348B1
公开(公告)日：2016-05-25
申请号：EP10839079.0
申请日：2010-11-08
申请人： Sawai Pharmaceutical Co., Ltd.
发明人： YANAGI, Toshihiro , NOZAWA, Kenji , MAEDA, Kazuaki , TAKADA, Shinya , OKAMURA, Yasufumi
IPC分类号： A61K31/40 , A61K9/32 , A61K47/32 , A61P3/06
CPC分类号： A61K9/284 , A61K31/40

6. 发明授权

EP2233129B1 ORAL CAVITY DISINTEGRATING TABLET AND METHOD OF PRODUCING THE SAME 有权
标题翻译：在口腔崩解片及其制造方法
公开(公告)号：EP2233129B1
公开(公告)日：2014-05-07
申请号：EP08868222.4
申请日：2008-12-26
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： OKUMURA, Tomonori , HAMAGUCHI, Nobuko , OKAMURA, Yasufumi
IPC分类号： A61K9/00 , A61K9/20 , A61K31/4422
CPC分类号： A61K31/4422 , A61K9/0056 , A61K9/2018 , A61K9/2054 , A61K9/2095

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