Comparison of dissolution of felodipine tablets of four pharmaceutical factories

Key words: 
• felodipine tablets /
• dissolution /
• similar factor

Abstract: Objective :To compare the dissolution in vitro of felodipine tablets of four pharmaceutical factories so as to make a reference to clinical application of felodipine tablets. Methods :The dissolubility of felodipine tablets of four pharmaceutical factories was inspected in the following 5 mediums:water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution(the above 4 mediums were used according to the project of drug quality's re-evaluation in Japan)and the mediums that used in ChP 2005.The dissolution tests were proceeded using paddle method at 50 r/min. Results :The cumulative dissolution of all felodipine tablets in 30 min was over 80% when the mediums regulated in ChP 2005 was used.However,when the mediums that regulated in the project of drug quality's re-evaluation in Japan were used,only the products of one manufacture could dissolved over 90% in 6h. Conclusion :The dissolution of the same batch of felodipine tablets in different mediums verifies obviously.There are significant difference among the quality of the felodipine tablets of different pharmaceutical factories,which should be given attention to in clinical application.