基于曼尼托尔的配方中的pioglitazone化的压缩性行为:使用压缩模拟器和QbD方法进行的一项研究
Joseph Turemi Chunu1, Yildiz Ozalp1, Nailla Jiwa1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Near East University, Nicosia, TRNC, Turkey.
Pakistan journal of pharmaceutical sciences
|October 23, 2023
概括
这项研究使用压缩模拟器和统计软件优化了Pioglitazone Hydrochloride (PGZ) 口服可分散片. 结果显示,关键过程参数显著影响平板电脑的性能和药物释放,使得强大的配方开发.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 皮奥格利塔化 (PGZ) 是一种主要的抗糖尿病药物.
- 口服可分散片提供了改善的患者遵守.
- 了解平板电脑的压缩性对于配方开发至关重要.
研究的目的:
- 为了研究 Pioglitazone 化 (PGZ) 在口服可分散片中的可压缩性.
- 为了评估颗粒大小,助剂和压缩力对药片性质的影响.
- 使用压缩模拟器和统计分析优化PGZ平板电脑配方.
主要方法:
- 通过使用曼尼托尔和Ludiflash®直接压缩制备PGZ口服可分散片.
- 使用压缩模拟器在不同力 (5kN-20kN) 下压缩配方.
- 评估平板电脑的特性 (硬度,易碎性,分解,溶解) 和 Minitab 19TM 的应用以优化.
主要成果:
- 所有PGZ配方都表现出良好的压缩性.
- 压缩力和辅助剂选择显著影响了药片的性能和药物释放.
- 由Minitab 19TM预测的优化配方显示了可接受范围内的结果.
结论:
- 压缩模拟和Minitab 19TM是预测PGZ平板电脑压缩性的有效工具.
- 关键过程参数 (CPP) 可以调整以修改压缩性和优化平板电脑配方.
- 这项研究为开发强大的PGZ口服可分散片提供了宝贵的见解.
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