Development and Evaluation of Floating Bilayer Tablet Containing Combination of Oxethazine and Cefixime Trihydrate

Raghavendra R, Bhagawati ST, Manjunath K, Irappanavar S
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Abstract

Aim The objective of present work was to formulate and evaluate bilayer tablets of Oxethazine and Cefixime trihydrate developed by direct compression method for effectively treating gastric ulcer and H. pylori infection.Methods The tablets were prepared having immediate release layer of Oxethazine and sustained release layer of Cefixime trihydrate. Sodium starch glycolate was used as super disintegrant for immediate release layer. The bilayer tablets were prepared by direct compression method using HPMC K100 and natural polymers like xanthan gum guar gum karaya gum which release the drug for 12 hours. Pre-compression parameters post-compression parameters and physical characteristics were evaluated for prepared formulations.Results The release of the Oxethazine from the immediate release layer was found to be 94.6plusmn0.02 in 30 minutes. The release of Cefixime trihydrate for the sustained release floating layer was found to be 99.88plusmn0.06 in 12 hours. The data obtained from in vitro release were fitted into the various kinetic models Zero Order Higuchi First Order and Kors MeyerndashPepparsquos Model.Conclusion The bilayer tablets developed offer both immediate release of Oxethazine and sustained release of Cefixime trihydrate. This suggests their potential as a viable option for treating gastric ulcers and H. pylori infections using an innovative dosage form.
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氧乙嗪与三水合头孢克肟复合漂浮双层片的研制与评价
目的研制直接加压法制备的奥西嗪-三水合头孢克肟双层片,并对其治疗胃溃疡和幽门螺杆菌感染的疗效进行评价。方法采用氧乙嗪速释层和三水合头孢克肟缓释片。乙醇酸淀粉钠作为快速释放层的强力崩解剂。以HPMC K100为原料,以黄原胶、瓜尔胶、卡拉亚胶等天然聚合物为原料,采用直接加压法制备双层片,缓释时间为12小时。对制备的配方进行了预压缩参数、后压缩参数和物理特性评价。结果立即释放层在30 min内的释放量为94.6±0.02。三水合头孢克肟缓释浮层在12 h内的释放量为99.88±0.06。体外释放数据拟合为零阶Higuchi一阶动力学模型和Kors MeyerndashPepparsquos模型。结论制备的双层片既有奥西嗪的速释,又有三水合头孢克肟的缓释。这表明他们的潜力,作为一个可行的选择,治疗胃溃疡和幽门螺杆菌感染使用一种创新的剂型。
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