Evaluation of the crystalline and amorphous states of drug products by nanothermal analysis and Raman imaging
Evaluation of the crystalline and amorphous states of drug products by nanothermal analysis and Raman imaging
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DOI：
10.1016/j.jpba.2012.11.020
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发表时间：
2013-03-05
影响因子：
3.4
通讯作者：
Terada, Katuhide
中科院分区：
文献类型：
--
作者：
Nakamoto, Keizo;Urasaki, Tetsuhiko;Terada, Katuhide
近年来，人们对无定形制剂和其他特殊剂型的药物产品进行了研究，以实现足够的溶解度和崩解度。我们使用纳米热分析(Nano-TA)和拉曼成像方法评估了药物产品的晶态和非晶态的分布。与传统的差示扫描量热法相比，纳米TA可以更快地表征模型配方的晶态和非晶态，包括它们的成分分布，而不需要任何样品制备。在目前的研究中，根据特定模型配方获得的成像地图的视觉外观和活性药物成分(API)的物理化学性质进行了评估。此外，通过拉曼图谱对模型配方的晶态和非晶态进行了区分。研究发现，纳米TA可用于原料药的晶态和非晶态的表征以及其他成分的分布。这项技术可用于监测药物物质和剂型在炮制过程中晶型的变化。此外，纳米TA还可以用来表征非晶态。(C)2012爱思唯尔B.V.保留所有权利。
In recent years, amorphous formulations and other special dosage forms of drug products have been investigated to achieve adequate solubility and disintegration. We have evaluated the distribution of crystalline and amorphous states of a drug product using Nanothermal analysis (Nano-TA) and Raman imaging methods. Compared to conventional differential scanning calorimetry, Nano-TA can be used to more rapidly characterize the crystalline and amorphous states of model formulations, including their ingredient distributions, without any sample preparation. In the current study, imaging maps obtained for specific model formulations were evaluated on the basis of their visual appearance and the physicochemical properties of the active pharmaceutical ingredient (API). In addition, the crystalline and amorphous states of the model formulations were distinguished by Raman mapping. Nano-TA was found to be useful for the characterization of crystalline and amorphous states of APIs and the distribution of other ingredients. This technology could be used to monitor the changes in crystalline forms of drug substances and dosage forms during processing. In addition, Nano-TA can be used to characterize amorphous states. (C) 2012 Elsevier B.V. All rights reserved.