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首页> 外文期刊>Journal of Young Pharmacists >Formulation and Evaluation of Cephalexin Extended-release Matrix Tablets Using Hydroxy Propyl Methyl Cellulose as Rate-controlling Polymer
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Formulation and Evaluation of Cephalexin Extended-release Matrix Tablets Using Hydroxy Propyl Methyl Cellulose as Rate-controlling Polymer

机译：以羟丙基甲基纤维素为速率控制聚合物的头孢氨苄缓释基质片的研制与评价

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The present investigation reports the design and evaluation of six-hour extended release film-coated matrix tablets of cephalexin using different grades of hydrophilic polymer hydroxypropylmethylcellulose (HPMC) employing direct compression method. The preformulation studies performed included the physical compatibility studies, Differential Scanning Calorimetry analysis, drug characterization using Fourier Transform Infra Red spectroscopic analysis and particle size analysis using sieve method. The tablets were evaluated for weight variation, hardness, thickness and friability. Results of the studies indicate that the polymers used have significant release-retarding effect on the formulation. The dissolution profile comparison of the prepared batches P1 to P8 and market preparation (Sporidex AF 375) was done by using Food and Drug Administration-recommended similarity factor (f 2) determination. The formulation P8 (10% HPMC K4M, 15% HPMC 15cps) with a similarity factor (f 2) of 77.75 was selected as the optimized formulae for scale-up batches. The dissolution data of the best formulation P8 was fitted into zero order, first order, Higuchi and Korsemeyer-Peppas models to identify the pharmacokinetics and mechanism of drug release. The results of the accelerated stability study of best formulation P8 for three months revealed that storage conditions were not found to have made any significant changes in final formulation F3. The release of cephalexin was prolonged for 6 h by using polymer combinations of HPMC and a twice daily matrix tablet was formulated.
机译：本研究报告了使用不同等级的亲水聚合物羟丙基甲基纤维素（HPMC）采用直接压片法对头孢氨苄的六小时缓释膜包衣基质片剂进行设计和评估。进行的预制剂研究包括物理相容性研究，差示扫描量热分析，使用傅立叶变换红外光谱分析的药物表征和使用筛分法的粒度分析。评价片剂的重量变化，硬度，厚度和易碎性。研究结果表明，所用聚合物对制剂具有显着的缓释作用。使用食品和药物管理局推荐的相似因子（f 2 ）测定，对制得的批次P1至P8和市售制剂（Sporidex AF 375）的溶出度进行比较。选择具有77.75的相似因子（f 2 ）的配方P8（10％HPMC K4M，15％HPMC 15cps）作为按比例放大批次的优化配方。将最佳制剂P8的溶出度数据拟合为零阶，一阶，Higuchi和Korsemeyer-Peppas模型，以确定药物动力学和药物释放机理。最佳配方P8的三个月加速稳定性研究的结果表明，未发现储存条件对最终配方F 3 有任何显着变化。通过使用HPMC的聚合物组合，头孢氨苄的释放延长了6小时，并配制了每日两次的基质片剂。

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