摘要
磷酸西格列汀片为全球首个上市的二肽基肽酶-4(DPP-4)抑制剂,用于改善2型糖尿病患者的血糖控制,其仿制药的研发和注册申报成为近几年的一个热点。本文结合文献调研及近年审评经验,从处方开发、工艺研究、质量研究和控制、亚硝胺杂质控制、稳定性研究以及多规格间的BE试验豁免等方面,对磷酸西格列汀片仿制药药学研究中可能需要关注的问题进行探讨,以期为相关研发者提供一定的参考。
Sitagliptin Phosphate Tablets was the first DPP-4 inhibitor that had been approved for the therapy of type 2 diabetes in the world,and the development and application of its generic drugs have become one of the hot spots in recent years.Based on literature investigation and recent review experience,this paper discusses some issues which may be considered during pharmaceutical research and development of Generic Sitagliptin Phosphate Tablets from the aspects of formulation design,manufacturing process development,quality research and control,nitrosamine impurities control,stability studies and additional strength biowaiver,etc.,in order to provide some references for researchers.
作者
吴小飞
刘丹杏
张歆
王宏亮
WU Xiaofei;LIU Danxing;ZHANG Xin;WANG Hongliang(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《药学研究》
CAS
2024年第8期775-780,共6页
Journal of Pharmaceutical Research
关键词
磷酸西格列汀
仿制药
药学研究
亚硝胺杂质
生物等效性豁免
Sitagliptin phosphate
Generic drugs
Pharmaceutical research
Nitrosamine impurities
Biowaiver
