基于直接可压缩的即时和持续释放配方的稳定性性能,优化了兰尼蒂丁化的优化
Ali Aun1, Sana Hanif2, Ijaz Ali3
1Faculty of Pharmacy, The University of Lahore, Pakistan.
Pakistan journal of pharmaceutical sciences
|August 2, 2023
概括
这项研究开发了一种稳定的ranitidine化物 (RTD) 配方,使用直接压缩以乙纤维素. 优化的配方在六个月内表现出持续的药物释放和稳定性.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 兰尼提丁化 (RTD) 的稳定性受到水分的影响,特别是在湿颗粒时.
- 直接压缩提供了一个替代方案,以克服与湿颗粒处理相关的稳定性问题.
研究的目的:
- 开发一个稳定的RTD配方使用直接压缩与乙烯基纤维素.
- 优化RTD配方,以持续释放药物和增强稳定性.
主要方法:
- RTD与非高透性乙烯纤维素混合并直接压缩.
- 评估了物理,物理化学和稳定性特征.
- 进行了富里埃变换红外线 (FTIR) 分析和体外药物释放动力学.
主要成果:
- 优化的配方 (E2) 含有10%的乙纤维素显示持续释放长达6小时.
- 物理特性不受聚合物变化的影响;易碎性和重量变化符合USP限制.
- FTIR证实配方成分之间没有相互作用;遵循希克森-克劳尔动力学.
结论:
- 用乙纤维素直接压缩成功提高了RTD稳定性和持续的药物释放.
- 含有4%粉1500和10%乙烯纤维素的优化配方 (E2) 至少稳定六个月.
- 这种方法提供了一个可行的替代方案,用于配方湿度敏感药物,如RTD.
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