富马酸奎硫平胃保留黏附片的研制与表征

A. Setia
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引用次数: 0

摘要

研究背景与目的:开发胃保留体给药系统是口服给药途径的新途径之一。延长胃潴留时间是使药物获得更大治疗效果的理想选择。本研究旨在研制延长停留时间的奎硫平胃保留黏附片。方法:采用湿造粒法,以羟丙基甲基纤维素K4M、羟丙基纤维素、壳聚糖、卡波醇934P、羧甲基纤维素钠等不同黏附聚合物不同组合,制备不同配方(F1-F12)。对各制剂进行了溶胀指数、黏附强度、体外释药特性和物理性能等评价指标。结果:壳聚糖与卡波醇934P (F7)复配制剂具有良好的溶胀指数,黏附强度高达192.66 g,最大体外停留时间为10.14 h, 24 h体外累积释药率为96.26%。进一步采用x线法测定优化后的配方(F7)在家兔体内的滞留时间,并进行加速稳定性研究。结论:从释放研究、肿胀研究和黏附研究中可以看出,该制剂(F7)具有实现预期目标的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
FORMULATION AND CHARACTERIZATION OF GASTRORETENTIVE MUCOADHESIVE QUETIAPINE FUMARATE TABLETS
Background and the purpose of the study: Development of gastroretentive delivery system is one of novel approach in oral route of drug administration. Prolonging the gastric retention time is desirable for achieving greater therapeutic benefit of drug substance. The research was aimed to develop gastroretentive mucoadhesive tablets of quetiapine for prolonged residence time. Methods: The wet granulation method was used for the preparation of various formulations (F1-F12) using different mucoadhesive polymers viz. hydroxyl propyl methyl cellulose K4M, hydroxyl propyl cellulose, chitosan, carbopol 934P and sodium carboxy methyl cellulose in different combinations. The formulations were subjected to various evaluation parameters such as swelling index, mucoadhesive strength, in vitro drug release profile and physical properties. Results: The study showed that the formulation containing chitosan and carbopol 934P in combination (F7) exhibited good swelling index, high mucoadhesive strength of 192.66 g and maximum in vitro residence time (10.14 hrs) and in vitro cumulative drug release after 24 hrs (96.26%). The optimized formulation (F7) was further subjected to in vivo retention time determination in rabbit by X-ray technique and accelerated stability studies. Conclusion: The formulation (F7) had shown promising potential to achieve desired goal as depicted from the release studies, swelling studies & mucoadhesion studies.
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