透深度和有效样本大小对UV/Vis辐射在药品片中的表征
René Brands1, Lukas Fuchs2, Judith M Seyffer3
1Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, TU Dortmund University, 44227 Dortmund, Germany.
Journal of pharmaceutical sciences
|June 27, 2025
概括
紫外线/Vis光谱为药物片剂的实时释放测试 (RTRT) 提供了一种可靠的方法. 这项研究的特点是其有效的样本大小和透深度,证实其适用于质量控制.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 频谱学是一种光谱学.
背景情况:
- 制药行业正在转向实时释放测试 (RTRT),以提高质量和成本效益.
- 紫外线/紫外线光谱是一种具有成本效益和敏感的技术,适合RTRT.
- 描述UV/Vis光谱的有效样本大小和透深度对于验证其在RTRT中的使用至关重要.
研究的目的:
- 为了确定有效的样本大小和UV/Vis光谱的透深度,用于实时释放测试 (RTRT) 在药物片剂中.
- 通过评估样本代表性,评估UV/Vis光谱对RTRT的适用性.
主要方法:
- 制造了具有不同上层成分 (MCC,乳糖,神) 和厚度的双叶片.
- 使用直角对齐的探针记录了UV/Vis光谱,并通过实验和理论确定了透深度.
- 根据透深度计算有效样本大小,并使用微型CT来确认活性药物成分 (API) 的分布.
主要成果:
- 实验透深度达到了0.4毫米,理论最大值为1.38毫米.
- 确定最大有效样本体积为2.01mm3,显示波长和粒子大小的依赖性.
- 微CT分析证实了统一的API分布,验证了UV/Vis有效样本大小.
结论:
- 紫外线/Vis光谱学提供了可靠和验证的方法,用于RTRT在药物片剂中.
- 具有特征的有效样本大小和透深度支持使用紫外线/Vis光谱技术进行平板制剂过程中的质量控制.
- 这种技术为传统的离线测试方法提供了一个有希望的替代方案.
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