基于质量设计的快速分散的尼莫迪平片的开发:配方属性和释放动力学评估
Hira Akhtar1, Ghazala Raza Naqvi1, Farya Zafar2
1Department of Pharmaceutics, Faculty of Pharmacy, Federal Urdu University of Arts, Science & Technology, Karachi, Pakistan.
Pakistan journal of pharmaceutical sciences
|August 2, 2023
概括
快速分散的尼莫迪平片是使用设计质量方法开发的. 经过优化后的配方表现出了很好的易碎性,分解性和溶解性,遵循韦布尔模型.
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
背景情况:
- 快速分散的片剂可以改善患者的服药性,并快速释放药物.
- 尼莫迪平是一种通道阻塞剂,用于下大脑关节出血.
研究的目的:
- 使用设计质量 (QbD) 方法开发和优化快速分散的尼莫迪平片.
- 为了研究Avicel PH 102和Crospovidone对药片特性的影响.
主要方法:
- 使用中央复合材料设计的直接压缩方法.
- 选择Avicel PH 102和Crospovidone作为独立变量.
- 对配方的易碎性,分解性,硬度和溶解性的评估.
- 使用扫描电子显微镜 (SEM),热重力测量分析 (TGA) 和差分热分析 (DTA) 的表征.
主要成果:
- 优化的配方 (F4) 含有35%的阿维塞尔PH102和5%的克罗斯波维.
- F4表现出理想的特性:0.59%的脆性,9秒的分解,95.703%的溶解和4.14公斤的硬度.
- 响应表面方法 (RSM) 图表有效指导了优化过程.
结论:
- QbD方法成功优化了快速分散的尼莫迪平片.
- 优化的配方显示出出色的物理和性能特征.
- 所有开发的配方都遵循韦布尔的药物释放动力学模型.
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