Chinese Journal of Pharmaceuticals, Volume. 56, Issue 7, 908(2025)
Investigation on Dissolution Profiles of Nitrendipine Tablets
LIU Qian, CHEN Yang, ZHANG Bin, YANG Yongjian, and JIN Wei*
Author Affiliations
NMPA Key Lab for Quality Analysis of Chemical Drug Preparations, Shanghai Institute for Food and Drug Control, Shanghai 201203show less
The in vitro dissolution behavior of nitrendipine (1) tablets produced by seven different companies and the reference formulation (Bayotensin® mite) was investigated. According to the dissolution test conditions of the Japanese Pharmacopoeia (JP18), an ultra-high performance liquid chromatography (UPLC) method was established to determine the dissolution of 1 tablets. The paddle method was used, with a speed of 100 r/min, and 900 mL of 1.5 g/L polysorbate 80 solution as the dissolution medium. The similarity factor (f2) method and the dissolution curve similarity parameter (AV value) method were used to compared the differences in dissolution behavior between 1 tablets from seven companies and the reference formulation. The results showed that there were significant differences in the dissolution curves of 1 tablets from six companies and the reference formulation, whereas the sample from E company exhibited similarity (f2=57.5, AV=13.4). In addition, a physiologically based pharmacokinetic (PBPK) model for 1 tablets was established using GastroPlusTM software, and the method for predicting the dissolution rate of JP18 showed good in vitro and in vivo correlation. Substituting the in vitro dissolution curve for virtual bioequivalence simulation, the bioequivalence prediction results were basically consistent with the similarity results of the dissolution curve, which provided a reference for the development and screening of the prescription for 1 tablets.