“FORMULATION DEVELOPMENT AND EVALUATION OF GASTRORETENTIVE FLOATING FILMS OF LAFUTIDINE”

Hir. R. Mehta, V. Patel
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Abstract

The present invention was aimed to formulate and evaluate Lafutidine gastro retentive films. The films were prepared by solvent casting technique using different film forming polymers like HPMC and Ethyl cellulose. PEG 400 used as a plastsizer. The prepared films were evaluated for number of parameters like Physical appearance, Weight variation, Thickness, Folding endurance, Tensile strength, unfolding behavior, floating properties, drug content and In vitro drug release studies. From the trial batches the best release for gastroretentive film was shown by formulation T5 (Ethyl cellulose and PEG 400). Formulation T5 exhibited good appearance, better mechanical strength with acceptable flexibility. Also, formulation T5 was given more than 90 % drug released after 12 hr and 97.56 % Drug content.  For optimization of formulation, 32 factorial design was applied by taking Ethyl cellulose and PEG 400 as an independent variables. Drug release at 8 hour and folding endurance selected as dependent variables. Based on drug release study, L8 batch found most satisfactory in all formulation and the effect of Ethyl cellulose and PEG 400 found significant. L8 batch found stable during stability study. Key words: Lafutidine, Floating Films, Ethyl Cellulose.
拉弗丁胃保留漂浮膜的配方开发与评价
本发明旨在制备和评价拉富丁胃保留膜。采用溶剂铸造技术,采用HPMC和乙基纤维素等不同成膜聚合物制备膜。peg400用作塑化剂。对制备的膜进行了物理外观、重量变化、厚度、折叠耐力、拉伸强度、展开行为、漂浮性能、药物含量和体外药物释放研究等参数的评价。从试验批次来看,配方T5(乙基纤维素和peg400)对胃保留膜的释放效果最好。配方T5具有良好的外观,较好的机械强度和可接受的柔韧性。制剂T5 12 h释药率达90%以上,药物含量达97.56%。以乙基纤维素和PEG 400为自变量,采用32因子设计优化配方。8小时药物释放和折叠时间作为因变量。药物释放试验结果表明,L8批在所有剂型中效果最理想,乙基纤维素和PEG 400效果显著。稳定性研究发现L8批次是稳定的。关键词:拉弗丁,浮膜,乙基纤维素
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