A new method based on flow-through cell apparatus to evaluate dissolution consistency of nimodipine tablets

VernacularTitle:基于流通池装置的新溶出方法用于尼莫地平片的一致性评价
Author: Hui LI ¹ ; Yueqing ZHAO ; Niyanhan JIANG ; Zeneng CHENG
Author Information

1. 中南大学湘雅药学院
Keywords: flow-through cell; dissolution test; in vitro and in vivo correlation; consistency evaluation; nimodipine tablet
From: Journal of China Pharmaceutical University 2018;49(3):301-309
CountryChina
Language:Chinese
Abstract: A new method of dissolution test was established to better simulate the in vivo dissolution behavior of drugs from preparations and to distinguish the quality difference between drug preparations. With flow-through cell being chosen to be the dissolution apparatus and nimodipine tablet to be the model drugs,this study developed,on the basis of IVIVC theory,a new dissolution method which was subsequently used to evaluate the dissolution con-sistency of domestically produced nimodipine tablet as test preparation and its reference preparation. Meanwhile, conventional four-dissolution-curves method based on paddle apparatus was selected for comparison to evaluate the efficiency of the new dissolution method. The results indicated that the new dissolution method not only had a good correlation with the in vivo process of drugs,but also could reveal the internal quality differences between pharmaceutical preparations effectively. This research will provide further theoretical support for the application of flow-through cell apparatus in IVIVC study.