公开(公告)号：US20230129146A1

公开(公告)日：2023-04-27

申请号：US18085842

申请日：2022-12-21

申请人： ASTELLAS PHARMA INC.

发明人： Masakazu MIYAZAKI ,  Ryohei ISHIBA ,  Yuki TAKAISHI ,  Fumiaki UEJO

IPC分类号： A61K31/497 ,  A61K47/26 ,  A61K47/10 ,  A61K9/20

摘要： Provided is a stable pharmaceutical composition for oral administration comprising 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (hereinafter referred to as compound A) or a pharmaceutically acceptable salt thereof, wherein the generation of related substances during storage is inhibited. In the stable pharmaceutical composition for oral administration, the proportion of crystals of compound A or a pharmaceutically acceptable salt thereof is 60% or more with respect to the total amount of compound A or a pharmaceutically acceptable salt thereof.

公开(公告)号：US20180185359A1

公开(公告)日：2018-07-05

申请号：US15741377

申请日：2016-07-01

申请人： ASTELLAS PHARMA INC.

发明人： Masakazu MIYAZAKI ,  Ryohei ISHIBA ,  Yuki TAKAISHI ,  Fumiaki UEJO

IPC分类号： A61K31/497 ,  A61K9/20 ,  A61K47/26

摘要： Provided is a stable pharmaceutical composition for oral administration comprising 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (hereinafter referred to as compound A) or a pharmaceutically acceptable salt thereof, wherein the generation of related substances during storage is inhibited. In the stable pharmaceutical composition for oral administration, the proportion of crystals of compound A or a pharmaceutically acceptable salt thereof is 60% or more with respect to the total amount of compound A or a pharmaceutically acceptable salt thereof.