高度悬浮剂的注射性使用模型微粒
Kavin Kowsari1, Lynn Lu1, Steven C Persak1
1Device Development and Technology, Merck Research Laboratories, Merck & Co. Inc., Rahway, NJ 07065, USA.
Journal of pharmaceutical sciences
|October 6, 2024
概括
高度颗粒悬浮剂可以在注射过程中堵塞针头. 这项研究开发了一种可视化和测量堵塞的方法,发现更大的针径和颗粒密度减少了堵塞,而粘度和颗粒大小增加了堵塞.
科学领域:
- 制药科学 制药科学
- 生物材料工程 生物材料工程
- 药物输送系统 药物输送系统
背景情况:
- 高度颗粒悬浮剂由于针塞,对注射具有挑战性.
- 在注射器-针系统中的颗粒桥梁和过,危及剂量准确性和可注射性.
- 对于这些输送系统中堵塞的启动存在有限的理解.
研究的目的:
- 为了实验性地描述悬浮剂的短暂注射行为.
- 调查影响悬浮颗粒堵塞和针塞的因素.
- 为量化含药物颗粒悬浮物中堵塞风险提供一个框架.
主要方法:
- 开发了一种定制的光标记和成像技术,配有集成的力传感器.
- 在注射过程中,视觉观察局部颗粒度和监测活塞力.
- 系统地研究了粒子特性,载体粘度,注射速率,装置尺寸和组织逆压的影响.
主要成果:
- 增加了针的内径 (ID) 和颗粒密度,显著降低了堵塞风险.
- 增加的车辆粘度,颗粒大小和组织反压力显著增加了堵塞.
- 确定了影响悬浮剂注射性和剂量输送的关键参数.
结论:
- 开发的实验框架有效量化了颗粒悬浮中的堵塞风险.
- 结果为平衡药物影响的颗粒设计与注射可行性提供了指导方针.
- 可以对配方和设备参数做出明智的决定,以优化药物输送.
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