公开(公告)号：US20230355631A1

公开(公告)日：2023-11-09

申请号：US18246463

申请日：2020-11-09

申请人： NANJING GRITPHARMA CO., LTD.

发明人： Hongyan HE ,  Qianqian ZHANG ,  Jiannan YANG ,  Yazhou HE ,  Yizhang ZUO ,  Lu ZHAO ,  Weiye WEI ,  Liru HUO ,  Zhan LI

IPC分类号： A61K31/519 ,  A61K9/16 ,  A61K9/48

CPC分类号： A61K31/519 ,  A61K9/1694 ,  A61K9/1652 ,  A61K9/1635 ,  A61K9/1611 ,  A61K9/4825 ,  A61K9/485

摘要： The present invention discloses a process for improving the fluidity of palbociclib isethionate and a composition, and belongs to the field of pharmaceutical preparations. The process includes a step of conducting granulation on palbociclib isethionate and pharmaceutically acceptable auxiliary materials to obtain granules with a tap density of 0.55-0.72 g/mL and an angle of repose of less than or equal to 44°. According to the process of the present invention, the palbociclib isethionate composition has good granular fluidity during filling of capsules, and prepared palbociclib isethionate capsules have uniform content, good stability and controllable quality. A preparation method is convenient to operate and easy to understand and adjust, and has good controllability in expanded production.

公开(公告)号：US20230248731A1

公开(公告)日：2023-08-10

申请号：US18188973

申请日：2023-03-23

申请人： NANJING GRITPHARMA CO., LTD.

发明人： Hongyan HE ,  Jiannan Yang ,  Yazhou He ,  Yizhang Zuo ,  Ruju Xiong ,  Jinling Li ,  Xiaotao Wu ,  Liru Huo ,  Zhan Li

IPC分类号： A61K31/519 ,  A61K9/16

CPC分类号： A61K31/519 ,  A61K9/1611 ,  A61K9/1623 ,  A61K9/1652

摘要： The present invention discloses a composition of palbociclib isethionate and a medicament, and belongs to the technical field of pharmaceutical preparations. The composition includes palbociclib isethionate, a diluent, a disintegrant and a lubricant, as well as optionally a glidant. The palbociclib isethionate in the composition has a release rate of greater than or equal to 60% at a pH of 6.8 at 60 min. According to technical solutions of the present invention, influence of the pH environment in the human body on the release of a palbociclib isethionate medicament is reduced, the restriction that a medicament needs to be taken after a meal is overcome, and the medicament prepared from the composition of palbociclib isethionate can be taken before or after a meal without the restriction of achieving different effects when the medicament is taken before or after a meal.