Evaluation of Three Approaches for Real-Time Monitoring of Roller Compaction with Near-Infrared Spectroscopy

被引:37
作者
Acevedo, David [1 ]
Muliadi, Ariel [2 ]
Giridhar, Arun [3 ]
Litster, James D. [3 ,4 ]
Romanach, Rodolfo J. [5 ]
机构
[1] Univ Puerto Rico, Dept Chem Engn, Mayaguez, PR 00682 USA
[2] Purdue Univ, Sch Mech Engn, W Lafayette, IN 47907 USA
[3] Purdue Univ, Sch Chem Engn, W Lafayette, IN 47907 USA
[4] Purdue Univ, Dept Ind & Phys Pharm, W Lafayette, IN 47907 USA
[5] Univ Puerto Rico, Dept Chem, Mayaguez, PR 00682 USA
来源
AAPS PHARMSCITECH | 2012年 / 13卷 / 03期
基金
美国国家科学基金会;
关键词
density distribution; near-infrared spectroscopy; process analytical technology; quality by design; roller compaction; PHARMACEUTICAL POWDERS; GRANULAR SOLIDS; ROLLING THEORY; PARAMETERS; STRENGTH; DENSITY;
D O I
10.1208/s12249-012-9825-0
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Three different approaches have been evaluated for monitoring ribbon density through real-time near-infrared spectroscopy measurements. The roll compactor was operated to produce microcrystalline cellulose (MCC) ribbons of varying densities. The first approach used the slope of the spectra which showed a variation through the ribbon that could be attributed to density. A second qualitative approach was also developed with a principal component analysis (PCA) model with spectra taken in-line during the production of ribbons in an ideal roll pressure range. The PCA (i.e., real-time) density scans show that the model was able to qualitatively capture the density responses resulting from variation in process parameters. The third approach involved multivariate partial least squares (PLS) calibration models developed at wavelength regions of 1,120-1,310 and 1,305-2,205 nm. Also, various PLS models were developed using three reference methods: caliper, pycnometer, and in-line laser. The third approach shows a quantitative difference between the model-predicted and the measured densities. Models developed at high-wavelength region showed highest accuracy compared with models at low-wavelength region. All the PLS models showed a high accuracy along the spectra collected throughout the production of the ribbons. The three methods showed applicability to process control monitoring by describing the changes in density during in-line sampling.
引用
收藏
页码:1005 / 1012
页数:8
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