评估光学一致性断层扫描和X射线计算机断层扫描以测量平板电脑薄膜涂层厚度
Emily Sanchez1, Trent Eastman1, Jennifer Potter2
1Pharmaceutical Commercialization Technology, MMD, Merck & Co., Inc., Rahway, NJ 07065, USA.
Pharmaceutics
|September 27, 2025
概括
光学连贯断层扫描和X射线计算机断层扫描是测量平板电脑薄膜层厚度的可行方法. 方法的选择取决于药片的特性和药物开发所需的精度.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 图像技术技术的成像技术
背景情况:
- 薄膜涂层对于固体口服剂型至关重要,影响药物释放和产品完整性.
- 优化薄膜涂层厚度对于平板电脑的优雅,机械强度和可控释放功能至关重要.
- 目前关于薄膜厚度测量的研究主要侧重于制造规模的在线方法.
研究的目的:
- 评估光学一致性断层扫描 (OCT) 和X射线计算机断层扫描 (XCT) 用于测量平板电脑片膜层厚度.
- 将这些技术与药物制药产品开发背景中的Confocal显微镜基线进行比较.
- 根据平板电脑的特性和性能标准来评估方法的适用性.
主要方法:
- 评估了四种不同尺寸,形状和涂层厚度的药片类型.
- 采用光学一致性断层扫描和X射线计算机断层扫描用于厚度测量.
- 用第二个仪器验证了OCT的准确性,并使用了对焦显微镜来确定参考值.
主要成果:
- 最初的海外和海外测量显示出差异,但后续研究证实了可接受的准确性.
- 射线计算机断层扫描提供了准确的测量,但由于分辨率,它面临着精确性挑战.
- OCT是透明涂层片的理想选择;XCT更适合小小的片 (透明或不透明的涂层).
结论:
- 光学连贯断层扫描,X射线计算机断层扫描和聚焦显微镜都是有效的平板电脑膜层厚度测量.
- 最佳的方法取决于安全性,可用性,适应性和平板电脑特性等特定因素.
- 这项研究为选择平板电脑开发中最合适的薄膜厚度测量技术提供了指导.
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