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Formulation Designing and Evaluation of pH responsive Enteric layered preparation of Model Drug

Rakesh Patel , Bijal Prajapati , Rajesh K S , Hardik Patel


The aim of this study was to prevent the drug release in stomach. The pellets were prepared based on full factorial design. Independent variables were % of PVP K30 (1, 3, 5) and ratio of Eudragit S100 to Eudragit L100 (2:1, 1:1, 1:2). The evaluated response were Drug content, % Drug release in 0.1N HCL, % Drug release in phosphate buffer. Surface characteristics, Sphericity, Aspect ratio, Friability of pellet were also evaluated. Linear regression and response surface modeling was used for analysis result. It show that addition of higher amount of PVP K30 result in higher drug release in 0.1N HCL, high drug content, no effect on drug release in phosphate buffer and has complex effect on overall desirability. Addition of Eudragit S100: Eudragit L100 in ratio of 1:2 show high drug release in phosphate buffer because high amount of Eudragit L100 dissolve fast and disappear enteric coating layer and release drug faster. Eudragit S100:Eudragit L100 has complex effect on drug content and overall desirability. Desirability function was employed to select an optimized batch. The batch that had desirability value near to one was considered to be optimized. In the present work, Batch G had highest desirability value of 0.75.

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