显微镜支持的磁盘溶解系统:从无形固体分散磁盘和视觉磁盘降解中的药物和聚合物溶解之间的一致性.
Shuaiqian Men1, James E Polli1
1Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Journal of pharmaceutical sciences
|October 25, 2024
概括
一个新的以显微镜启用的磁盘溶解系统 (MeDDiS) 准确地预测无形固体分散 (ASD) 的药物和聚合物释放. 溶解ASD盘的成像与测量释放概况相关,识别关键药物负载极限.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 药物输送系统 药物输送系统
背景情况:
- 无形固体分散 (ASD) 对于提高药物溶解度至关重要.
- 预测ASD中药物负载分散性极限对于配方开发至关重要.
- 现有的评估ASD表现的方法往往缺乏实时视觉反.
研究的目的:
- 开发了一种具有更大的溶解体积 (900毫升) 的新型显微镜驱动磁盘溶解系统 (MeDDiS).
- 评估MeDDiS成像数据与传统溶解测量数据之间的一致性.
- 评估MeDDiS在ASD患者不同药物负载中预测药物和聚合物释放概况的能力.
主要方法:
- 在不同的药物负载 (5-50%) 中制造含有里托纳维尔和PVPVA的ASD磁盘.
- 使用集成在1升溶解容器 (MeDDiS) 中的数字显微镜进行实时成像.
- 随着时间的推移量化磁盘直径的变化,并测量里托纳维尔和PVPVA释放.
主要成果:
- MeDDiS成像显示与测量的药物和聚合物溶解概况有很强的一致性.
- 确定了临界药物负载"悬崖",约为30%的里托纳维尔负载,低于此,释放显著减少.
- MeDDiS成功地预测了高和低释放概况,这些概况在已识别的药物负载极限以上和以下.
结论:
- 开发的MeDDiS提供了一个有前途的工具,用于实时评估ASD溶解行为.
- MeDDiS成像可以准确预测药物和聚合物释放,有助于确定最佳的ASD药物负载.
- 这种方法为ASD性能提供了有价值的见解,特别是在关键配方极限周围.
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