Formulation and Evaluation of Sustained Release Matrix Tablet of Itopride

G. Reddy, Ashok Kumar V, S. V. Kulkarni
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Abstract

The objective of this research work was to carry out design and evaluation of sustained release matrix tablets of Itopride by use of natural and synthetic polymers. Matrix tablets were prepared by wet granulation technique by using natural polymers like Carbopol 934, Tamarind poly saccharide, Locust bean gum, Ethyl cellulose, HPMC K 100 as matrix forming agent and excipients such as Lactose, Starch 1500, Magnesium stearate, MCC and talc were used. The dissolution medium consisted of 900 ml of 0.1 N HCl for first 2 hours and then 7.4 phosphate buffer for remaining 10 hours. The release of Itopride from matrix containing lactose, micro crystalline cellulose and starch 1500 as diluents. The drug release rate was found in order of lactose> micro crystalline cellulose>starch 1500. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The release data were fit into different kinetic models (zero-order, first- order, Higuchi’s equation and Korsmeyer-Peppas equation). Optimized formulation was tested for their compatibility with Itopride by FT-IR studies, which revealed that there is no chemical interaction occurred with polymer and other excipients. The drug release profile of the best formulation was well controlled and uniform throughout the dissolution studies. Keywords: Matrix tablets, Itopride, Carbopol 934, HPMC K 100, Ethyl cellulose.
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依托普利缓释基质片的处方及评价
本研究的目的是利用天然聚合物和合成聚合物对依托必利基质缓释片进行设计和评价。以卡波波尔934、罗望子多糖、槐豆胶、乙基纤维素、HPMC k100等天然高聚物为基质形成剂,以乳糖、淀粉1500、硬脂酸镁、MCC、滑石粉等辅料为辅料,采用湿造粒技术制备基质片。溶解介质为900 ml 0.1 N HCl,前2小时用,后10小时用7.4磷酸缓冲液。以乳糖、微晶纤维素和淀粉1500为稀释剂的基质中释放依托必利。药物释放率为乳糖>微晶纤维素>淀粉1500。以可接受的片剂性能和体外释放度为指标,对处方进行优化。将释放数据拟合为不同的动力学模型(零阶、一阶、Higuchi方程和Korsmeyer-Peppas方程)。通过红外光谱(FT-IR)测试了优化后的制剂与依托必利的配伍性,发现其与聚合物和其他赋形剂无化学相互作用。在整个溶出度研究中,最佳制剂的药物释放曲线控制良好且均匀。关键词:基质片,依托普利,卡波波尔934,HPMC k100,乙基纤维素
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