Study Of Felodipine Sustained Release Tablets'

In this paper, a sustained release tablet with Felodopine as a model drug was prepared in order to provide an effective drug for the treatment of high blood pressure with prolonged and mild action.The formulation of felodopine sustained release tablets with a dosage of 5 mg was optimized and its quality and stability was carried out, and its quality control standard was established.The formulation of felodopine sustained release tablets was optimized by the evaluation of felodopine release. The formulation for 1000 tablets contained felodopine 5 g, HPMC (k15M) 35 g, HPMC (50cps), and microcrystalline cellulose 133 g.Oxidized product, relative substances and content of felodopine in the sustained release tablet were evaluated and compared with reference drug Plendil. Quality of the resulting sustained release tablet meet the state quality standard. Felodopine sustained release tablets and Plendil were quantitatively equivalent. The release rate of felodopine from HPMC matrix tablets followed zero-order release, and accumulating release amount was as the same as Plendil.Effective factors on the stability of the sustained release tablets were high temperature and light rays. The three-batch samples in pilot-scale and manufacturing-scale were investigated in accelerated condition for six-month and the long-term experiments. The oxidized product, relative substances and drug content had no significant changes. It is suggested that the sustained release tablets should be stored at room temperature tightly and free from light.