Similarity Evaluation of the Dissolution Curves between Generic and Original Metoprolol Tartrate Tablets

VernacularTitle:酒石酸美托洛尔片仿制药与原研药溶出曲线的相似性评价
Author: Bin KONG ; Xinxia LI ; Guizhen PEI ; Xinwen QI ; Wenjun LI
Keywords: Metoprolol tartrate tablets; Dissolution curves; Fiber-optical drug dissolution real-time measurement instrument; Similarity factor
From: China Pharmacy 2017;28(9):1262-1264
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To establish the method for dissolution determination of Metoprolol tartrate tablets,and to evaluate the similarity of dissolution curves of generics and original drugs. METHODS:The paddle method was adopted with rotational the speed of 50 r/min,using pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. Fiber-optical drug dissolution real-time measurement instrument was used to determine the dissolution curves of generic and original Metoprolol tartrate tablets with optical distance of 10 mm. Similarity factor (f2) method was used to evaluate its similarity. RESULTS:In 3 dissolution mediums,the f2 of generic and original Metoprolon tartrate tablets were 80.5,66.8, 69.4,respectively,which indicated that the dissolution curves showed similarity. CONCLUSIONS:Established real-time dissolution process analysis method is suitabe for the dissolution determination of Metoprolol tartrate tablets. Generic and eriginal show the sim-ilarity in dissolation behavier,so they have good consistency in quality.