A Process Analytical Technology approach to near-infrared process control of pharmaceutical powder blending: Part II: Qualitative near-infrared models for prediction of blend homogeneity

The successful implementation of near-infrared spectroscopy (NIRS) in process control of powder blending requires constructing an inclusive spectral database that reflects the anticipated voluntary or involuntary changes in processing conditions, thereby minimizing bias in prediction of blending beh...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2006-02, Vol.95 (2), p.407-421
Main Authors: El-Hagrasy, Arwa S., Delgado-Lopez, Miriam, Drennen, James K.
Format: Article
Language:English
Subjects:
Algorithms
Biological and medical sciences
blend uniformity analysis
Chemistry, Pharmaceutical - methods
General pharmacology
global model
Lactose - chemistry
Medical sciences
Methanol - chemistry
mixing
Models, Chemical
Multivariate Analysis
near-infrared spectroscopy
nonparametric pattern recognition algorithms
Particle Size
Pharmaceutical Preparations - chemistry
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Powders - chemistry
principal component analysis
Process Analytical Technology (PAT)
Salicylic Acid - chemistry
SIMCA
Spectroscopy, Near-Infrared - methods
Technology, Pharmaceutical
UV/VIS spectroscopy
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Summary:The successful implementation of near-infrared spectroscopy (NIRS) in process control of powder blending requires constructing an inclusive spectral database that reflects the anticipated voluntary or involuntary changes in processing conditions, thereby minimizing bias in prediction of blending behavior. In this study, experimental design was utilized as an efficient way of generating blend experiments conducted under varying processing conditions such as humidity, blender speed and component concentration. NIR spectral data, collected from different blending experiments, was used to build qualitative models for prediction of blend homogeneity. Two pattern recognition algorithms: Soft Independent Modeling of Class Analogies (SIMCA) and Principal Component Modified Bootstrap Error-adjusted Single-sample Technique (PC-MBEST) were evaluated for qualitative analysis of NIR blending data. Optimization of NIR models, for the two algorithms, was achieved by proper selection of spectral processing, and training set samples. The models developed were successful in predicting blend homogeneity of independent blend samples under different processing conditions. © 2005 Wiley-Liss, Inc. and the American Pharmacists Association
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20466