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多尺度X射线成像和药物剂量形式的表征

Martina Olsson¹, Rydvikha Govender², Ana Diaz³

¹Department of Physics, Chalmers University of Technology, SE-412 96 Gothenburg, Sweden.

International journal of pharmaceutics

|July 6, 2023

概括

这项研究引入了一种多尺度成像方法,将图形X射线计算纳米图形 (PXCT) 和扫描小和广角X射线散射 (S/WAXS) 结合起来,以分析固体剂型. 该技术揭示了药物形态和固态相分布,这对于配方性能至关重要.

科学领域:

材料科学材料科学材料科学
制药科学制药科学
先进的成像技术,以及先进的成像技术.

背景情况:

固体剂型的性能严重依赖于药物形态和固态阶段.
理解结构-属性关系需要从纳米到毫米的多尺度表征.
当前的成像技术往往缺乏能够完全捕捉复杂的固体剂型结构的分辨率或尺度.

研究的目的:

提出一种相关的多尺度成像方法,用于可视化和量化固体剂型的形态.
建立一个多尺度分析的工作流程,将纳米到毫米尺度的桥梁.
证明该方法在描述特定药物配方中的药物形态和固态阶段方面的能力.

主要方法:

结合图形X射线计算纳米图形 (PXCT) 以80nm分辨率进行3D形态可视化.
使用扫描小和广角X射线散射 (S/WAXS) 进行纳米结构和多态形状分析.
将综合方法应用于在乙烯纤维素中化卡巴马西的热挤压固体分散.

主要成果:

PXCT揭示了晶体药物领域的定向3D形态,与扩展体积的挤出方向保持一致.
S/WAXS在挤出线丝的截面上显示出一致的纳米结构,在域大小和方向上有轻微的辐射变化.
WAXS在固体分散中发现了 I 和 II 形式的转移性卡巴马泽的异质分布.

结论:

开发的多尺度成像方法允许对固体剂型进行全面的结构性表征.
这种方法增强了对形态,处理和性能之间的复杂关系的理解.
这些发现为通过详细的结构洞察力优化药物配方提供了基础.

关键词:

卡巴马西平是一种碳化合物.图形图像X射线计算纳米图形学扫描SAXS/WAXS的扫描固体的分散固体的分散的 μXRDD 的值.

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