公开(公告)号：US20240076261A1

公开(公告)日：2024-03-07

申请号：US18270725

申请日：2022-03-24

申请人： ZHEJIANG NHU COMPANY LTD.

发明人： JINLONG LIU ,  SHUMIN LV ,  RUIJUN HU ,  XUEZHONG HE ,  MENGLIANG DU ,  XIAOCHUN WANG ,  ZIYU WANG ,  LANYING LIANG

IPC分类号： C07C51/43

CPC分类号： C07C51/43 ,  C07B2200/13

摘要： The present invention discloses a method for preparing an ibuprofen spherical crystal having high bulk density and a product thereof. The method includes: (1) heating ibuprofen until a molten liquid state is reached; and (2) pressurizing the molten liquid state of ibuprofen, dropping the molten liquid state of ibuprofen into a crystallizer filled with water through a liquid distributor for crystallization under stirring conditions until the molten liquid state of ibuprofen is completely dropped, lowering the rotation speed of stirring to allow crystal growing, and finally, subjecting a resulting crystal slurry to post-treatment to obtain the ibuprofen spherical crystal having high bulk density. The ibuprofen spherical crystal has a bulk density of 0.50-0.70 g/mL, a tap density of 0.63-0.89 g/mL, a median particle size of 300-1,000 μm and an angle of repose of 22-29°. The method of the present invention features that the process thereof is simple, and that no additives are used, such that the method is suitable for industrial production. The ibuprofen spherical crystal prepared has regular crystal habit, smooth crystal surface, good fluidity, high bulk density and high product purity. The quality of a product meets requirements of CP2020, EP9.8, USP41 and other pharmacopoeias.