Atomic force microscopy-based screening of drug-excipient miscibility and stability of solid dispersions.
Atomic force microscopy-based screening of drug-excipient miscibility and stability of solid dispersions.
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DOI：
10.1007/s11095-010-0306-4
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发表时间：
2011-03
影响因子：
3.7
通讯作者：
Alsenz, Jochem
中科院分区：
文献类型：
--
作者：
Lauer, Matthias Eckhard;Grassmann, Olaf;Siam, Monira;Tardio, Joseph;Jacob, Laurence;Page, Susanne;Kindt, Johannes Heinrich;Engel, Andreas;Alsenz, Jochem
开发了一种使用基于熔融的混合方法来评估药物/聚合物的相容性和固体分散体稳定性的方法。制备了非晶态断裂薄膜，并结合拉曼显微镜和原子力显微镜对其进行了表征，以区分均匀和非均匀混合的药物/聚合物组合。进一步分析了均匀组合在压力条件下的物理稳定性，例如增加的湿度或温度。确定了有可能形成分子分散混合物的组合。它们的相分离潜力是通过分子长度尺度的成像来确定的，这导致了较短的观察时间。通过相分离分析来量化解混，并对药物/聚合物组合进行排序以确定最稳定的组合。结果表明，用原子力显微镜可以分析药物/聚合物的相容性和固体分散体的稳定性，具有许多机理细节。该检测方法可以在几小时或几天内鉴定出相容良好和稳定的组合。本文的在线版本(doi：10.1007/s11095.010306-4)包含补充材料，授权用户可以使用。
Development of a method to assess the drug/polymer miscibility and stability of solid dispersions using a melt-based mixing method. Amorphous fractured films are prepared and characterized with Raman Microscopy in combination with Atomic Force Microscopy to discriminate between homogenously and heterogeneously mixed drug/polymer combinations. The homogenous combinations are analyzed further for physical stability under stress conditions, such as increased humidity or temperature. Combinations that have the potential to form a molecular disperse mixture are identified. Their potential to phase separate is determined through imaging at molecular length scales, which results in short observation time. De-mixing is quantified by phase separation analysis, and the drug/polymer combinations are ranked to identify the most stable combinations. The presented results demonstrate that drug/polymer miscibility and stability of solid dispersions, with many mechanistic details, can be analyzed with Atomic Force Microscopy. The assay allows to identify well-miscible and stable combinations within hours or a few days. The online version of this article (doi:10.1007/s11095-010-0306-4) contains supplementary material, which is available to authorized users.
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