埃普利酮漂浮双层片的研制及评价

T. Pallavi, G. S. Sharma, B. Rama, L. Rani, B. Rajkamal
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摘要

胃保留给药系统已被广泛应用于延长剂型在胃中的保留。在各种方法中,浮动双层片剂配方具有持续的药物释放和延长的胃潴留,以及液体口服剂型的额外优势。本研究以瓜尔胶、乙基纤维素、SSG、CCS等聚合物为原料,制备了埃普勒酮漂浮双层片剂,并对其进行了评价。对制备的双层浮片进行硬度、重量变化、厚度、脆性、药物含量均匀性和体外溶出度评价。综合各项评价参数,选择F3 (IR)和F12 (SR)为最佳配方。从上述浮力研究可知,F12的总浮力时间高于其他配方。观察到F3 (IR)和F12 (SR)制剂在一定时间内释药效果最好。采用零级、一阶、Higuchi矩阵、Peppas模型方程对各制剂进行了药物释放动力学研究,其中缓释制剂均为零级释放,具有非粘性扩散机制。
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Formulation and evaluation of floating bilayer tablets of epleronone
Gastro retentive drug delivery systems have been widely used to prolong retention of dosage forms in stomach. Among the various approaches, the floating bilayer tablets formulation offers sustained drug release as well as prolonged gastric retention, along with the added advantage of liquid oral dosage form. The present study was an attempt to formulate and evaluate floating bilayer tablets of Epleronone by using various polymers like guar gum, ethyl cellulose, SSG, CCS. The prepared floating Bilayered tablets were evaluated for hardness, Weight variation, thickness, friability, drug content uniformity, and in-vitro dissolution studies. Based on various evaluation parameters formulation F3 (IR) & F12 (SR) was selected as optimized formulation. From the above floating buoyancy studies shows that F12 shows higher Total floating time than other formulations. It was observed that Formulations F3 (IR) & F12 (SR) gave maximum drug release within time. All formulations were subjected for drug release kinetics studies viz. Zero order, first order, Higuchi matrix, Peppas model equations and the formulations of sustained release (SR) formulations followed zero order release with non-fickian diffusion mechanism.
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