Preparation and Evaluation of Sustained Release Matrix Tablets of Acelofenac and Comparision of Formulated and Marketed Product

Vimal Singh, Vipin Kumar Sharma, Praveen Kumar, J. Kumar, Madhav Mohan, Neda Anzar, Tushar Cheetu, Raj Kumar
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Abstract

The aim of performing this study is to develop matrix tablet to improve the dissolution rate of aceclofenac and release the drug in a controlled manner over a period of 24 hours. Matrix tablets of aceclofenac, using various viscosity of hydrophilic polymer HPMC in two different proportions, hydrophobic polymer ethyl cellulose and Guar gum were prepared by wet granulation method and subjected to in vitro drug release studies. Tablets were evaluated for in vitro drug release profile in phosphate buffer with pH 7.5. The thickness and hardness of prepared tablets were 3.8 ± 0.2 to 3.9 ±0.2 mm and 4 ± 3 to 5 ± 3 kg/cm2, respectively. The friability was within the acceptable limits of pharmacopeial specifications (0.31 to 0.71%), which indicates the good mechanical strength of the tablets. The in vitro drug release from the proposed system was best explained by Higuchi’s model, indicating that drug release from tablets displayed a diffusion-controlled mechanism. Based on the study results, formulation F7 was selected as the best formulation.
阿塞洛芬酸缓释基质片的制备和评估以及制剂与市场产品的比较
本研究旨在开发基质片剂,以提高醋氯芬酸的溶解速率,并在 24 小时内以可控方式释放药物。研究人员采用湿法制粒法,以两种不同比例的亲水性聚合物 HPMC、疏水性聚合物乙基纤维素和瓜尔胶为原料,制备了不同粘度的醋氯芬酸基质片剂,并进行了体外药物释放研究。片剂在 pH 值为 7.5 的磷酸盐缓冲液中进行了体外药物释放谱评价。所制备片剂的厚度和硬度分别为 3.8 ± 0.2 至 3.9 ± 0.2 mm 和 4 ± 3 至 5 ± 3 kg/cm2。片剂的易碎性在药典规定的可接受范围内(0.31% 至 0.71%),这表明片剂具有良好的机械强度。樋口模型最能解释拟议体系的体外药物释放情况,表明片剂的药物释放表现出一种扩散控制机制。根据研究结果,配方 F7 被选为最佳配方。
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