Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and Young's modulus of roller compacted powder blends

被引:82
作者
Gupta, A
Peck, GE
Miller, RW
Morris, KR
机构
[1] Purdue Univ, Sch Pharm, Dept Ind & Phys Pharm, W Lafayette, IN 47907 USA
[2] Bristol Myers Squibb Co, New Brunswick, NJ 08903 USA
关键词
process analytical technology (PAT); near-infrared spectroscopy; real-time monitoring; on-line monitoring; in-line monitoring; dry granulation; compaction; roller compaction; compact strength; three-point beam bending method; density; content uniformity; multivariate data analysis;
D O I
10.1002/jps.20375
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A method for real-time in-line near-infrared (NIR) monitoring of roller compaction is reported. Multivariate analysis using partial least square projections to latent structures (PLS) was used to relate the spectral data with key compact attributes: content uniformity, moisture content, relative density, tensile strength, and Young's modulus. NIR calibration curves were generated using the spectral data collected on simulated ribbons, that is, tablets prepared under uni-axial compression, and tested on the data collected on another set of simulated ribbons and by monitoring the ribbons as they exited the roller compactor. For all compact attributes, the NIR predicted values agreed well with the values measured using a reference method. (c) 2005 Wiley-Liss, Inc. and the American Pharmacists Association.
引用
收藏
页码:1589 / 1597
页数:9
相关论文
共 23 条
[1]   Development and validation of a method for the polymorphic analysis of pharmaceutical preparations using near infrared spectroscopy [J].
Blanco, M ;
Villar, A .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2003, 92 (04) :823-830
[2]   Prediction of drug content and hardness of intact tablets using artificial neural network and near-infrared spectroscopy [J].
Chen, YX ;
Thosar, SS ;
Forbess, RA ;
Kemper, MS ;
Rubinovitz, RL ;
Shukla, AJ .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2001, 27 (07) :623-631
[3]   A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in Bohle bin-blender [J].
Duong, NH ;
Arratia, P ;
Muzzio, F ;
Lange, A ;
Timmermans, J ;
Reynolds, S .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2003, 29 (06) :679-687
[4]   Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity [J].
El-Hagrasy, AS ;
Morris, HR ;
D'Amico, F ;
Lodder, RA ;
Drennen, JK .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2001, 90 (09) :1298-1307
[5]   Near-infrared mass median particle size determination of lactose monohydrate, evaluating several chemometric approaches [J].
Frake, P ;
Gill, I ;
Luscombe, CN ;
Rudd, DR ;
Waterhouse, J ;
Jayasorriya, UA .
ANALYST, 1998, 123 (10) :2043-2046
[6]   Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy [J].
Gupta, A ;
Peck, GE ;
Miller, RW ;
Morris, KR .
JOURNAL OF PHARMACEUTICAL SCIENCES, 2004, 93 (04) :1047-1053
[7]  
GUPTA A, 2005, UNPUB J PHARM SCI
[8]   Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm [J].
Kirsch, JD ;
Drennen, JK .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1999, 19 (3-4) :351-362
[9]   Near-infrared spectroscopic monitoring of the film coating process [J].
Kirsch, JD ;
Drennen, JK .
PHARMACEUTICAL RESEARCH, 1996, 13 (02) :234-237
[10]   Development and validation of a near-infrared method for the quantitation of caffeine in intact single tablets [J].
Laasonen, M ;
Harmia-Pulkkinen, T ;
Simard, C ;
Räsänen, M ;
Vuorela, H .
ANALYTICAL CHEMISTRY, 2003, 75 (04) :754-760