公开(公告)号：US20240293402A1

公开(公告)日：2024-09-05

申请号：US18567435

申请日：2022-06-08

Applicant: CHUGAI SEIYAKU KABUSHIKI KAISHA

Inventor： Kenichi SAKAI ,  Hiromasa UCHIYAMA ,  Tomoyuki MINODA ,  Mayumi YOSHIKAWA ,  Shigemori NATSUMOTO ,  Ryusuke TAKANO

IPC: A61K31/506 ,  A61K9/48

CPC classification number: A61K31/506 ,  A61K9/4858 ,  A61K9/4866

Abstract: The present invention provides a pharmaceutical composition having excellent dissolution property and content uniformity and a production method thereof by mixing a p-toluenesulfonate of 7-[[2,3-difluoro-4-[2-[2-methoxyethyl(methyl)amino]ethoxy]phenyl]methyl]-10-hydroxy-6-methyl-8-oxo-N-[4-(trifluoromethyl)-2-[6-(trifluoromethyl)pyrimidin-4-yl]phenyl]-6,7-diazaspiro[4,5]deca-9-ene-9-carboxamide with specific additives, and formulating the mixture.