曼尼托尔涂层基基甲基纤维素作为湿度敏感药物的直接可压缩可控制释放辅助剂:稳定性前景
Christina Yong Xin Kang1,2, Keat Theng Chow1, Yuan Siang Lui1
1Roquette Asia Pacific Pte. Ltd., 11 Biopolis Way, Helios, #05-06, Singapore 138667, Singapore.
Pharmaceuticals (Basel, Switzerland)
|September 28, 2024
概括
曼尼托尔涂层基基甲基纤维素 (HPMC) 通过降低水分吸收,与标准HPMC相比,改善控制释放片中的药物稳定性,有利于对水分敏感的药物.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 基甲基纤维素 (HPMC) 是控制释放矩阵片中常见的水友性聚合物.
- 由于HPMC具有吸引水分的特性,可能会损害对水分敏感药物的稳定性.
研究的目的:
- 为了评估辅助剂的水分吸附行为和在矩阵片中的阿司匹林稳定性.
- 为了比较标准HPMC与新型曼尼托尔涂层HPMC的性能.
主要方法:
- 含有阿司匹林的矩阵片使用HPMC和涂有曼尼托尔的HPMC进行了配方.
- 辅助剂的水分吸附和药物稳定性在加快条件下 (40°C,75%RH) 在开放和关闭的盘中进行了评估.
主要成果:
- 曼尼托尔涂层HPMC药片的阿司匹林降解速度比标准HPMC药片慢.
- 最初的水分含量和湿度可视性是药物稳定性的关键预测因素.
- 由于潜在的自催化,阿司匹林降解在后期阶段在封闭条件下加速.
结论:
- 谨慎的辅助剂选择对于最大限度地提高湿度敏感药物的化学稳定性至关重要.
- 曼尼托尔涂层HPMC是一种可行的辅助剂,用于直接压缩,可控释放剂型,增强药物稳定性.
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