使用基于米散射的光板技术对可见粒子进行非破坏性分析:系统开发
Mingshu Liang1, Monica Goss2, Shawn Cao2
1California Institute of Technology, Electrical Engineering, Pasadena, CA 91125, USA.
Journal of pharmaceutical sciences
|July 20, 2024
概括
一个新的非破坏性分析仪可以检测药物产品中的可见微粒 (SbVPs),而不会损坏样品. 该方法准确量化完整瓶子中的颗粒大小和度,改善药品质量控制.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 微可见粒子 (SbVPs) 是可注射和眼科溶液的关键质量属性.
- 目前的测试方法 (光阻塞,微观计数) 是破坏性的,样本密集的.
- 需要使用非破坏性方法来分析最终药品容器中的SbVPs.
研究的目的:
- 开发和验证在药品药品 (DP) 容器中的可见微粒 (SbVPs) 的非破坏性分析仪.
- 为了能够在完整的DP容器中直接分析SbVPs,从而保持样本的完整性.
- 提高药品质量控制测试的效率,减少药品质量控制测试中的浪费.
主要方法:
- 开发一个集成光片显微镜的非破坏性SbVP分析仪.
- 利用定制的样品外来最大限度地减少容器曲率造成的光学偏差.
- 应用Mie散射理论与折射率来建模粒子散射事件和估计大小.
- 基于散射事件和光片体积的量化颗粒度.
主要成果:
- 分析仪成功检测到SbVPs直接在完整的ISO 2R和6R瓶中.
- 能够将检测到的SbVP分类到标准尺寸的容器中 (≥2μm,≥5μm,≥10μm,≥25μm).
- 可靠量化SbVP度从4.6e2到5.0e5颗粒/毫升,误差为±15% (90%置信区间).
结论:
- 开发的分析仪为制药药品中的SbVP分析提供了一个非破坏性的解决方案.
- 允许在没有样本破坏的情况下直接在现场分析关键质量属性.
- 提供精确的颗粒大小和量化,增强药品质量控制过程.
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