Title:
STABLE PHARMACEUTICAL COMPOSITION FOR ORAL ADMINSITRATION
Document Type and Number:
WIPO Patent Application WO/2017/006855
Kind Code:
A1
Abstract:
Provided is a stable pharmaceutical composition for oral administration containing 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidine-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (compound A hereinafter), or a pharmacologically acceptable salt thereof, that suppresses the generation of related substances during storage. The proportion of crystals of the compound A or pharmacologically acceptable salt thereof in the stable pharmaceutical composition for oral administration is 60% or higher relative to the total weight of the compound A or pharmacologically acceptable salt thereof.
Inventors:
MIYAZAKI MASAKAZU (JP)
ISHIBA RYOHEI (JP)
TAKAISHI YUUKI (JP)
UEJO FUMIAKI (JP)
ISHIBA RYOHEI (JP)
TAKAISHI YUUKI (JP)
UEJO FUMIAKI (JP)
Application Number:
PCT/JP2016/069615
Publication Date:
January 12, 2017
Filing Date:
July 01, 2016
Export Citation:
Assignee:
ASTELLAS PHARMA INC (JP)
International Classes:
A61K31/497; A61K9/20; A61K47/10; A61K47/26; A61P35/00
Domestic Patent References:
| WO2010128659A1 | 2010-11-11 | |||
| WO2015119122A1 | 2015-08-13 |
Foreign References:
| JP2014501770A | 2014-01-23 |
Other References:
YOSHINOBU NAKAI: "Relationship between powder characteristics and the pharmaceutical preparations", JOURNAL OF THE SOCIETY OF POWDER TECHNOLOGY, JAPAN, vol. 25, no. 6, 1988, pages 388 - 394, XP055344928, ISSN: 0386-6157
See also references of EP 3318259A4
See also references of EP 3318259A4
Attorney, Agent or Firm:
MORITA Kenichi et al. (JP)
Download PDF: