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使用同步龙X射线微型计算机断层扫描对含有乙氨基或卡巴马的单个药剂颗粒进行动态干燥的实验研究

Carter Blocka¹, Xiao Fan Ding², Ning Zhu³

¹Department of Chemical and Biological Engineering, University of Saskatchewan, Saskatoon, SK, Canada.

International journal of pharmaceutics

|September 11, 2024

概括

这项研究使用X射线成像观察制药颗粒干燥,揭示了成分和干燥时间如何影响内部变化. 结果显示,材料特性在干燥过程中显著影响水分去除和毛孔结构演变.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
化学工程是化学工程的重要组成部分.

背景情况:

干燥在制药片制造中至关重要,因为它会影响颗粒的特性.
在单颗粒干燥过程中量化内部变化在实验上具有挑战性.
当前的方法通常依赖于建模和模拟.

研究的目的:

为了研究单个药品颗粒的动态干燥,使用现场同步基X射线成像.
通过实验量化干燥过程中的内部变化.
了解颗粒组成和干燥参数对干燥动力学的影响.

主要方法:

使用乳糖单水合物 (LMH),微晶纤维素 (MCC),乙氨基 (APAP) 和碳氨酸 (CBZ) 作为纯成分或二元混合物生成单个制药颗粒.
利用现场基于同步射线的X射线成像来监测动态干燥.
控制的水分含量在25%至30%之间.

主要成果:

干燥时间和成分对大多数样品的孔积演变和湿度比有显著的影响.
干燥空气的速度和温度对孔隙连接性和水分去除有不同的影响,这取决于样品的成分.
活性成分加载对卡巴马泽 (CBZ) 干燥的影响最小,而乙氨基 (APAP) 混合物的干燥主要是由于其水友性.

结论:

在现场的X射线成像为内部颗粒干燥动态提供了新的见解.
颗粒的成分,特别是水性,是干燥行为的关键决定因素.
了解这些干燥机制有助于优化制药制造工艺.

关键词:

干燥干燥干燥颗粒状材料是一种颗粒状材料.含水量含水量含水量药品制造业药品制造业药品制造业药品制造业多孔性多孔性同步机同步机同步机.在X射线成像中使用X射线成像.

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