- 专利标题: STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION
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申请号: US18085842申请日: 2022-12-21
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公开(公告)号: US20230129146A1公开(公告)日: 2023-04-27
- 发明人: Masakazu MIYAZAKI , Ryohei ISHIBA , Yuki TAKAISHI , Fumiaki UEJO
- 申请人: ASTELLAS PHARMA INC.
- 申请人地址: JP Tokyo
- 专利权人: ASTELLAS PHARMA INC.
- 当前专利权人: ASTELLAS PHARMA INC.
- 当前专利权人地址: JP Tokyo
- 优先权: JP2015-134817 20150703
- 主分类号: A61K31/497
- 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.
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