使用光学连贯性断层扫描在实验室中监测药物释放过程
Matthias Wolfgang1, Tihana Baniček1, Amrit Paudel2
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, Graz 8010, Austria.
Journal of pharmaceutical and biomedical analysis
|June 3, 2024
概括
这项研究引入了一种新的光学连贯性断层扫描 (OCT) 方法,用于在现场分析修饰释放药物释放的药片. 该技术精确地监测薄膜厚度,胀和多孔性,增强剂型设计.
科学领域:
- 药品制造 药品制造 药品制造
- 生物医学工程 生物医学工程
- 材料科学 材料科学 材料科学
背景情况:
- 修改释放片对于在胃肠道 (GI) 内向药物输送至关重要.
- 了解涂层剂型中药物释放过程中的物理化学过程至关重要,但没有得到充分描述.
- 现有的方法缺乏分辨率来研究在体外药物释放过程中的地下现象.
研究的目的:
- 开发和验证一种新的体外试验,用于在薄膜片中药物释放过程中的地表下过程的现场调查.
- 利用光学连贯断层扫描 (OCT) 进行高分辨率的监测,以检测修饰释放剂型中的动态变化.
- 提高对药物释放机制的理解,以实现以患者为中心的剂型设计.
主要方法:
- 开发一种使用光学连贯性断层扫描 (OCT) 的新型体外试验系统.
- 薄膜涂层修改释放药片的现场监测,特别是透控制释放口服输送系统 (OROS).
- 高分辨率 (微米尺度) 和高时间 (小于10毫秒) 的图像成像,在溶解过程中显示片的微观结构变化.
主要成果:
- 基于OCT的方法成功监测了膜厚度和可变性,表面粗性,核心胀和矩阵孔隙性.
- 证明了在体外药物释放过程中跟踪OROS平板微观结构内的动态变化的能力.
- 实现了前所未有的空间和时间分辨率,用于分析药物溶解过程中的地下现象.
结论:
- 这种基于OCT的新型体外试验提供了一个强大的工具,用于在现场描述修饰释放剂型的剂型.
- 这种方法可以更深入地了解控制复杂药片配方药物释放的物理化学动态.
- 这些发现为先进的以患者为中心的药物输送系统的设计,优化和质量控制开辟了新的途径.
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