傅里叶变换近红外分析在药物热熔挤出过程中的在线实时监测中的应用：技术说明。
Application of FT-NIR Analysis for In-line and Real-Time Monitoring of Pharmaceutical Hot Melt Extrusion: a Technical Note.
机构信息
Department of Pharmaceutics and Drug Delivery, University of Mississippi, University, Mississippi, 38677, USA.
Thermo Fisher Scientific, Waltham, Massachusetts, USA.
出版信息
AAPS PharmSciTech. 2018 Nov;19(8):3425-3429. doi: 10.1208/s12249-018-1091-3. Epub 2018 Jun 13.
Abstract
Continuous manufacturing, a gaining interest paradigm in the pharmaceutical industry, requires in-process monitoring of critical process parameters to ensure product consistency. This study demonstrated the application of Fourier transform near-infrared (FT-NIR) spectroscopy in conjunction with chemometrics modeling for in-line hot melt extrusion process monitoring. The obtained results suggested that inline FT-NIR analysis, along with a tailored NIR reflector, is a viable process analytical tool to monitor active pharmaceutical ingredient concentration as well as processing parameters.
摘要
连续制造是制药行业日益关注的一个范例，需要对关键工艺参数进行过程监测，以确保产品的一致性。本研究展示了傅里叶变换近红外（FT-NIR）光谱结合化学计量学建模在热熔挤出过程在线监测中的应用。结果表明，在线 FT-NIR 分析结合特制的 NIR 反射镜是一种可行的过程分析工具，可用于监测活性药物成分浓度以及加工参数。
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