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统计优化和制作包衣脉冲式给药系统以治疗夜间酸突破

Statistical optimization and fabrication of a press coated pulsatile dosage form to treat nocturnal acid breakthrough.

机构信息

Meerut Institute of Engineering and Technology, NH-58, Baghpat Bypass, Meerut-250005, Uttar Pradesh, India.

出版信息

Curr Drug Deliv. 2013 Aug;10(4):444-52. doi: 10.2174/1567201811310040009.

DOI:10.2174/1567201811310040009
PMID:23253145
Abstract

OBJECTIVE

Present work focuses on the use of mimosa seed gum to develop a drug delivery system making combined use of floating and pulsatile principles, for the chrono-prevention of nocturnal acid breakthrough.

METHODOLOGY

The desired aim was achieved by fabricating a floating delivery system bearing time - lagged coating of Mimosa pudica seed polymer for the programmed release of Famotidine. Response Surface Methodology was the statistical tool that was employed for experiment designing, mathematical model generation and optimization study. A 3(2) full factorial design was used in designing the experiment.% weight ratio of mimosa gum to hydroxy propyl methyl cellulose in the coating combination and the coating weight were the independent variables, whereas the lag time and the cumulative % drug release in 360 minutes were the observed responses.

KEY FINDINGS

Results revealed that both the coating composition and the coating weight significantly affected the release of drug from the dosage form.

CONCLUSION

The optimized formulation prepared according to the computer generated software, Design-Expert(®) deciphered response which were in close proximity with the experimental responses, thus confirming the robustness as well as accuracy of the predicted model for the utilization of natural polymer like mimosa seed gum for the chronotherapeutic treatment of nocturnal acid breakthrough.

摘要

目的

本研究专注于使用金合欢种子胶开发一种药物递送系统,结合使用漂浮和脉冲原理,用于夜间酸突破的定时预防。

方法

通过制备一种漂浮递送系统,该系统具有时间滞后的含羞草种子聚合物涂层,用于法莫替丁的程序释放,从而实现了预期的目标。响应面法是用于实验设计、数学模型生成和优化研究的统计工具。采用 3(2)完全析因设计进行实验设计。%金合欢胶与羟丙基甲基纤维素在涂层组合中的重量比和涂层重量为自变量,而滞后时间和 360 分钟内的累积药物释放%为观察响应。

主要发现

结果表明,涂层成分和涂层重量都显著影响药物从剂型中的释放。

结论

根据计算机生成的软件 Design-Expert(®) 设计出的优化配方,其响应与实验响应非常接近,从而证实了该预测模型的稳健性和准确性,可用于利用天然聚合物如金合欢种子胶进行夜间酸突破的定时治疗。

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