FORMULATION AND IN-VITRO EVALUATION OF NICARDIPINE HYDROCHLORIDE BILAYERED TABLET FOR CONTROLLED RELEASE

Jyoti Bhusan Singh, P. Mourya, G. Rai, R. Shukla
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Abstract

The aim of present research work was to prepare and evaluate the controlled release bilayered tablet of Nicardipine HCL to improve its bioavailability for the treatment of hypertension. To minimize critical process parameters, two layer compression method was used for the formulation of Bilayered tablets. The appropriate formulation was achieved successfully with the combination of Polymers MCC, Carbopol 71G and HPMC K100M produced desired release profile for Metoprolol succinate extended release layer. The combination of disintegrating agents that is Sodium starch glycolate and Dicalcium phosphate produced desired release rate for Nicardipine immediate release layer. The results reveal that formulation F7 has met the objective of controlled drug release for over a period of 12 hrs. The formulation F7 ascertained the efficacy of the controlled released Bilayered tablet of Nicardipine and Metoprolol ER tablet in hypertension. This sustained release Bilayered tablet with the combination of Nicardipine and metoprolol can be used in the management of different types of hypertension. The formulation F7 of combination of Nicardipine and metoprolol showed controlled release profile among the other, Hence it was considered as an optimized formulation.
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盐酸尼卡地平双层控释片的处方及体外评价
本研究的目的是制备并评价盐酸尼卡地平控释片,以提高其治疗高血压的生物利用度。为使关键工艺参数最小化,采用双层压缩法制备双层片。通过聚合物MCC、Carbopol 71G和HPMC K100M的组合,获得了合适的处方,获得了理想的琥珀酸美托洛尔缓释层释放曲线。以乙醇酸淀粉钠和磷酸二钙为崩解剂,对尼卡地平的速释层产生了理想的释放速率。结果表明,F7制剂达到了12 h以上的控释目标。F7确定尼卡地平美托洛尔内窥镜控释双层片治疗高血压的疗效。该缓释片与尼卡地平、美托洛尔联用可用于不同类型高血压的治疗。尼卡地平与美托洛尔联用处方F7具有较好的控释效果,为最佳处方。
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