Relevant considerations on pharmaceutical research of Generic Sitagliptin Phosphate Tablets
WU Xiaofei
LIU Danxing
ZHANG Xin
WANG Hongliang
Abstract：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.
Keywords：Sitagliptin phosphateGeneric drugsPharmaceutical researchNitrosamine impuritiesBiowaiver
Publication Date：2024-08-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 775-780 )