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1. 发明公开

US20240009134A1 PREPARATION CONTAINING SAXAGLIPTIN AND METHOD FOR PRODUCING THE SAME 审中-公开
公开(公告)号：US20240009134A1
公开(公告)日：2024-01-11
申请号：US18371932
申请日：2023-09-22
申请人： SAWAI PHARMACEUTICAL Co., Ltd.
发明人： Kenji NOZAWA , Wataru IZUI , Ayane NATSUME , Daiki BIRUKAWA
IPC分类号： A61K9/20 , A61K31/403
CPC分类号： A61K9/2086 , A61K9/2018 , A61K9/2059 , A61K9/2009 , A61K9/2054 , A61K31/403
摘要： A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.

2. 发明授权

US11406600B2 Anhydrous dasatinib-containing preparation 有权
公开(公告)号：US11406600B2
公开(公告)日：2022-08-09
申请号：US16879408
申请日：2020-05-20
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： Michinori Oikawa , Hiroyuki Yamamoto , Hiroaki Kikuoka
IPC分类号： A61K9/28 , A61K31/506
摘要： An anhydrous dasatinib-containing preparation comprising an anhydrous dasatinib and a titanium oxide or colorant or antioxidant is provided. In one embodiment, the anhydrous dasatinib-containing preparation improves photostability upon storage. The weight ratio of the titanium oxide per the anhydrous dasatinib may be more than 0 and 2 or less, or the weight ratio of the colorant per the anhydrous dasatinib may be more than 0 and 1 or less, or the weight ratio of the antioxidant per the anhydrous dasatinib may be more than 0 and 0.5 or less.

3. 发明授权

US10588856B2 Orally disintegrating tablet coated with film 有权
公开(公告)号：US10588856B2
公开(公告)日：2020-03-17
申请号：US15233534
申请日：2016-08-10
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： Michinori Oikawa , Hiroyuki Yamamoto , Hiroaki Kikuoka
IPC分类号： A61K9/00 , A61K9/28
摘要： Provided is an orally disintegrating tablet coated with film that allows the time elapsed before a film thereof dissolves to be shorter, has a good feel when the tablet is taken, and is capable of being easily mass-produced. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature, and contains the plasticizer in 10% by weight or more with respect to a weight of the film coating base.

4. 发明申请

US20190154647A1 MOUTHFEEL EVALUATION METHOD AND MOUTHFEEL EVALUATION APPARATUS FOR ORALLY DISINTEGRATING TEST OBJECT 审中-公开
公开(公告)号：US20190154647A1
公开(公告)日：2019-05-23
申请号：US16258317
申请日：2019-01-25
申请人： SAWAI PHARMACEUTICAL Co., Ltd.
发明人： Masatoshi NAKATANI , Masaru SUGITA , Nobuaki IKEJI , Hiroaki KIKUOKA
IPC分类号： G01N33/02 , G01N3/40 , G01N3/08
摘要： A mouthfeel evaluation method for an orally disintegrating test object is provided, the method including, by a measurement apparatus, giving a predetermined distortion with a predetermine cycle as applying a predetermined pressure to the orally disintegrating test object, adding a predetermined amount of a test liquid to the test object, and measuring a loss tangent of the test object with time.

5. 发明申请

US20230083072A1 FILM-COATED GRANULE, PHARMACEUTICAL PREPARATION CONTAINING THE SAME, AND MANUFACTURING METHODS THEREOF 有权
公开(公告)号：US20230083072A1
公开(公告)日：2023-03-16
申请号：US17941129
申请日：2022-09-09
申请人： SAWAI PHARMACEUTICAL Co., Ltd.
发明人： Katsuhiko OMAGARI , Shinya TAKADA , Ryota KIMATA , Naoki YOSHIHARA
IPC分类号： A61K9/16 , A61K45/06
摘要： One of the problems of one embodiment of the present invention is to provide film-coated granules which have a new film constitution. Alternatively, one of the problems of one embodiment of the present invention is to provide a pharmaceutical preparation containing the film-coated granules which have a new film constitution. Alternatively, one of the problems of one embodiment of the present invention is to provide a new dry manufacturing method of the film-coated granules. Alternatively, one of the problems of one embodiment of the present invention is to provide a new dry manufacturing method of the pharmaceutical preparation containing the film-coated granules. According to one embodiment of the present invention, a film-coated granule is provided that comprises a core particle having a melt component, and a film arranged on a surface of the core particle, wherein the film includes a porous substance, a plasticizer and a polymer.

6. 发明申请

US20220370365A1 SOLID PREPARATION CONTAINING TAFAMIDIS AND METHOD FOR PRODUCING THE SAME 有权
公开(公告)号：US20220370365A1
公开(公告)日：2022-11-24
申请号：US17747276
申请日：2022-05-18
申请人： SAWAI PHARMACEUTICAL Co., Ltd.
发明人： Wataru IZUI , Daiki BIRUKAWA , Ayane NATSUME
IPC分类号： A61K9/20 , A61K31/423
摘要： A solid preparation containing tafamidis includes tafamidis, and a carrier containing one or more selected from a group consisting of magnesium aluminometasilicate, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and calcium silicate, and a method for producing the same are provided.

7. 发明授权

US11167031B2 Additive composition for orally disintegrating tablet 有权
公开(公告)号：US11167031B2
公开(公告)日：2021-11-09
申请号：US16294114
申请日：2019-03-06
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： Yoichi Higashiyama , Wataru Izui , Ayako Harada , Satoru Ogihara , Kenji Nozawa , Hiroaki Kikuoka
IPC分类号： A61K47/10 , A61K47/38 , A61K47/32 , A61K9/20 , A61K9/00
摘要： Provided is a novel additive for an orally disintegrating tablet providing quick disintegrability and tablet hardness to the orally disintegrating tablet, and a producing method therefor. According to an embodiment of the present invention, there is provided an additive for an orally disintegrating tablet characterized by including D-mannitol, low-substituted hydroxypropyl cellulose (however, excluding the low-substituted hydroxypropyl cellulose having a mean particle size of 20 μm or less and a substitution degree of hydroxypropoxy groups of 11%, a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 14%, and a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 11% and a 90% cumulated particle size of 100 μm or less), crospovidone, and microcrystalline cellulose, wherein the low-substituted hydroxypropyl cellulose and the crospovidone are included in a ratio of 5:4.

8. 发明申请

US20190201529A1 ADDITIVE COMPOSITION FOR ORALLY DISINTEGRATING TABLET 审中-公开
公开(公告)号：US20190201529A1
公开(公告)日：2019-07-04
申请号：US16294114
申请日：2019-03-06
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： Yoichi HIGASHIYAMA , Wataru IZUI , Ayako HARADA , Satoru OGIHARA , Kenji NOZAWA , Hiroaki KIKUOKA
IPC分类号： A61K47/10 , A61K47/38 , A61K47/32 , A61K9/20
CPC分类号： A61K47/10 , A61K9/20 , A61K9/2027 , A61K9/2054 , A61K9/2095 , A61K47/32 , A61K47/38
摘要： Provided is a novel additive for an orally disintegrating tablet providing quick disintegrability and tablet hardness to the orally disintegrating tablet, and a producing method therefor. According to an embodiment of the present invention, there is provided an additive for an orally disintegrating tablet characterized by including D-mannitol, low-substituted hydroxypropyl cellulose (however, excluding the low-substituted hydroxypropyl cellulose having a mean particle size of 20 μm or less and a substitution degree of hydroxypropoxy groups of 11%, a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 14%, and a mean particle size of 45 μm or less and a substitution degree of hydroxypropoxy groups of 11% and a 90% cumulated particle size of 100 μm or less), crospovidone, and microcrystalline cellulose, wherein the low-substituted hydroxypropyl cellulose and the crospovidone are included in a ratio of 5:4.

9. 发明申请

US20160346199A1 ORALLY DISINTEGRATING TABLET COATED WITH FILM 审中-公开
标题翻译：用薄膜涂抹的表面消毒片
公开(公告)号：US20160346199A1
公开(公告)日：2016-12-01
申请号：US15233534
申请日：2016-08-10
申请人： SAWAI PHARMACEUTICAL CO., LTD.
发明人： Michinori OIKAWA , Hiroyuki YAMAMOTO , Hiroaki KIKUOKA
IPC分类号： A61K9/00 , A61K9/28
摘要： Provided is an orally disintegrating tablet coated with film that allows the time elapsed before a film thereof dissolves to be shorter, has a good feel when the tablet is taken, and is capable of being easily mass-produced. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature. The orally disintegrating tablet coated with film is coated with a film coating composition, the film coating composition comprises a water-soluble and ethanol-insoluble film coating base; and at least one plasticizer selected from the group consisting of propylene glycol and polyethylene glycol in a liquid or semisolid state at room temperature, and contains the plasticizer in 10% by weight or more with respect to a weight of the film coating base.
摘要翻译：本发明提供一种涂膜的口腔崩解片，其能够使其膜溶解时间短，在使用片剂时具有良好的手感，能够容易地批量生产。涂覆有薄膜的口腔崩解片剂涂覆有薄膜包衣组合物，该薄膜包衣组合物包含水溶性和不溶于乙醇的薄膜包衣基料; 和在室温下以液体或半固体状态选自丙二醇和聚乙二醇的至少一种增塑剂。涂覆有薄膜的口腔崩解片剂涂覆有薄膜包衣组合物，该薄膜包衣组合物包含水溶性和不溶于乙醇的薄膜包衣基料; 和在室温下以液态或半固体状态选自丙二醇和聚乙二醇的至少一种增塑剂，相对于薄膜包衣基质的重量，含有10重量％以上的增塑剂。

10. 发明授权

US11786472B2 Preparation containing saxagliptin and method for producing the same 有权
公开(公告)号：US11786472B2
公开(公告)日：2023-10-17
申请号：US17354167
申请日：2021-06-22
申请人： SAWAI PHARMACEUTICAL Co., Ltd.
发明人： Kenji Nozawa , Wataru Izui , Ayane Natsume , Daiki Birukawa
IPC分类号： A61K9/20 , A61K31/403
CPC分类号： A61K9/2086 , A61K9/2009 , A61K9/2018 , A61K9/2054 , A61K9/2059 , A61K31/403
摘要： A preparation containing saxagliptin having improved stability and a method for producing the same are provided. According to an embodiment of the present invention, a preparation containing saxagliptin including a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part, and a film coating part in contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof, and a method for producing the same are provided.

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