Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes
Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes
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DOI：
10.1016/j.ijpharm.2010.12.012
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发表时间：
2011-09-30
影响因子：
5.8
通讯作者：
Vervaet, C.
中科院分区：
文献类型：
--
作者：
De Beer, T.;Burggraeve, A.;Vervaet, C.
在过程分析技术（PAT）框架内，在制药加工过程中获得关键工艺和配方信息至关重要。过程分析仪是实时过程监控和控制的重要PAT工具，因为它们提供从中提取相关过程和产品信息以及结论的数据。近十年来，近红外（NIR）和拉曼光谱越来越多地用于关键工艺和产品属性的实时测量，因为这些技术无需样品制备即可进行快速无损测量。此外，这两种技术都提供了化学和物理信息，从而增加了对过程的理解。通过光纤电缆连接到光谱仪的探头可以直接应用到过程流中，从而实现连续的过程中测量。本文旨在回顾拉曼和近红外光谱在PAT设置中的使用，即，在加工过程中，特别强调制药和剂型。(C)2010 Elsevier B.V.保留所有权利。
Within the Process Analytical Technology (PAT) framework, it is of utmost importance to obtain critical process and formulation information during pharmaceutical processing. Process analyzers are the essential PAT tools for real-time process monitoring and control as they supply the data from which relevant process and product information and conclusions are to be extracted. Since the last decade, near infrared (NIR) and Raman spectroscopy have been increasingly used for real-time measurements of critical process and product attributes, as these techniques allow rapid and nondestructive measurements without sample preparations. Furthermore, both techniques provide chemical and physical information leading to increased process understanding. Probes coupled to the spectrometers by fiber optic cables can be implemented directly into the process streams allowing continuous in-process measurements. This paper aims at reviewing the use of Raman and NIR spectroscopy in the PAT setting, i.e., during processing, with special emphasis in pharmaceutics and dosage forms. (C) 2010 Elsevier B.V. All rights reserved.