Near-Infrared Spatially Resolved Spectroscopy for Tablet Quality Determination

被引:18
作者
Igne, Benoit [1 ]
Talwar, Sameer [2 ]
Feng, Hanzhou [2 ]
Drennen, James K. [1 ,2 ]
Anderson, Carl A. [1 ,2 ]
机构
[1] Duquesne Univ, Duquesne Ctr Pharmaceut Technol, Pittsburgh, PA 15219 USA
[2] Duquesne Univ, Grad Sch Pharmaceut Sci, Pittsburgh, PA 15282 USA
关键词
near-infrared spectroscopy; partial least squares; multivariate analysis; chemometrics; content uniformity; diffuse reflectance; tableting; spatially resolved spectroscopy; IN-LINE; DIFFUSE-REFLECTANCE; NONINVASIVE DETERMINATION; GRANULATION PROCESS; CONTENT UNIFORMITY; PHOTON MIGRATION; PART; VALIDATION; FORMULATIONS; SPECTROMETRY;
D O I
10.1002/jps.24618
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Near-infrared (NIR) spectroscopy has become a well-established tool for the characterization of solid oral dosage forms manufacturing processes and finished products. In this work, the utility of a traditional single-point NIR measurement was compared with that of a spatially resolved spectroscopic (SRS) measurement for the determination of tablet assay. Experimental designs were used to create samples that allowed for calibration models to be developed and tested on both instruments. Samples possessing a poor distribution of ingredients (highly heterogeneous) were prepared by under-blending constituents prior to compaction to compare the analytical capabilities of the two NIR methods. The results indicate that SRS can provide spatial information that is usually obtainable only through imaging experiments for the determination of local heterogeneity and detection of abnormal tablets that would not be detected with single-point spectroscopy, thus complementing traditional NIR measurement systems for in-line, and in real-time tablet analysis. (C) 2015 Wiley Periodicals, Inc.
引用
收藏
页码:4074 / 4081
页数:8
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