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盐酸普萘洛尔缓释双层片的设计与评价

Design and evaluation of sustained release bilayer tablets of propranolol hydrochloride.

作者信息

Patra Chinam Niranjan, Kumar Arethi Bharani, Pandit Hemant Kumar, Singh Satya Prakash, Devi Meduri Vimala

机构信息

P. G. Department of Pharmaceutics, College of Pharmaceutical Sciences, Berhampur-760002 Orissa, India.

出版信息

Acta Pharm. 2007 Dec;57(4):479-89. doi: 10.2478/v10007-007-0038-0.

Abstract

The objective of the present research was to develop a bilayer tablet of propranolol hydrochloride using superdisintegrant sodium starch glycolate for the fast release layer and water immiscible polymers such as ethylcellulose, Eudragit RLPO and Eudragit RSPO for the sustaining layer. In vitro dissolution studies were carried out in a USP 24 apparatus I. The formulations gave an initial burst effect to provide the loading dose of the drug followed by sustained release for 12 h from the sustaining layer of matrix embedded tablets. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. FT-IR studies revealed that there was no interaction between the drug and polymers used in the study. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p < 0.05) in the amount of drug released after 12 h from optimized formulations was observed.

摘要

本研究的目的是开发一种盐酸普萘洛尔双层片,速释层使用超级崩解剂羟丙基淀粉甘醇酸钠,缓释层使用水不溶性聚合物,如乙基纤维素、丙烯酸树脂RLPO和丙烯酸树脂RSPO。体外溶出度研究在USP 24装置I中进行。这些制剂产生了初始突释效应以提供药物的负荷剂量,随后从基质包衣片的缓释层持续释放12小时。在初始突释后,体外溶出动力学通过非菲克扩散控制释放机制遵循 Higuchi 模型。傅里叶变换红外光谱 (FT-IR) 研究表明,研究中使用的药物与聚合物之间没有相互作用。统计分析(方差分析)显示,15分钟后药物累积释放量没有显著差异,但观察到优化制剂在12小时后药物释放量有显著差异(p < 0.05)。

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