公开(公告)号：EP3257511A1

公开(公告)日：2017-12-20

申请号：EP15882014.2

申请日：2015-09-10

申请人： FUJIFILM Corporation

发明人： OKADA, Kotaro ,  MORI, Hisahiro ,  TSUJIHATA, Shigetomo ,  SAKATA, Yoshinori

IPC分类号： A61K31/46 ,  A61K9/20 ,  A61K47/04 ,  A61K47/12 ,  A61K47/14 ,  A61K47/20 ,  A61K47/32 ,  A61P1/06 ,  A61P13/06 ,  A61P21/02 ,  A61P25/08

CPC分类号： A61K9/0056 ,  A61K9/2009 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2081 ,  A61K9/2086 ,  A61K9/2095 ,  A61K31/46 ,  A61K31/5383

摘要： An orally disintegrating tablet including: fine granules, each fine granule having, at its center, an active pharmaceutical ingredient-containing core that includes butylscopolamine bromide and water-insoluble particles, and having an intermediate layer that includes water-insoluble particles and coats the active pharmaceutical ingredient-containing core, and a bitterness-masking layer that includes talc and at least one water-insoluble polymer, in sequence from the active pharmaceutical ingredient-containing core side; and an excipient component positioned on the outside of the fine granules, and a method for producing the same.

摘要翻译： 一种口腔内崩解片剂，其特征在于，含有细粒，所述细粒在中央部具有含有丁基东莨菪碱溴化物和水不溶性粒子的活性药物成分核，具有含有非水溶性粒子的中间层， 含有药物成分的芯和含有滑石和至少一种水不溶性聚合物的苦味掩蔽层，从含活性药物成分的芯侧开始依次; 以及位于微粒外部的赋形成分及其制造方法。

公开(公告)号：EP3257511B1

公开(公告)日：2018-10-24

申请号：EP15882014.2

申请日：2015-09-10

申请人： FUJIFILM Corporation

发明人： OKADA, Kotaro ,  MORI, Hisahiro ,  TSUJIHATA, Shigetomo ,  SAKATA, Yoshinori

IPC分类号： A61K31/46 ,  A61K9/20 ,  A61K47/04 ,  A61K47/12 ,  A61K47/14 ,  A61K47/20 ,  A61K47/32 ,  A61P1/06 ,  A61P13/06 ,  A61P21/02 ,  A61P25/08

CPC分类号： A61K9/0056 ,  A61K9/2009 ,  A61K9/2013 ,  A61K9/2027 ,  A61K9/2081 ,  A61K9/2086 ,  A61K9/2095 ,  A61K31/46 ,  A61K31/5383

摘要： An orally disintegrating tablet including: fine granules, each fine granule having, at its center, an active pharmaceutical ingredient-containing core that includes butylscopolamine bromide and water-insoluble particles, and having an intermediate layer that includes water-insoluble particles and coats the active pharmaceutical ingredient-containing core, and a bitterness-masking layer that includes talc and at least one water-insoluble polymer, in sequence from the active pharmaceutical ingredient-containing core side; and an excipient component positioned on the outside of the fine granules, and a method for producing the same.