TY - JOUR
T1 - Near-infrared chemical imaging (NIR-CI) as a process monitoring solution for a production line of roll compaction and tableting
AU - Khorasani, Milad
AU - Amigo, José M.
AU - Sun, Changquan Calvin
AU - Bertelsen, Poul
AU - Rantanen, Jukka
N1 - Publisher Copyright:
© 2015 Elsevier B.V. All rights reserved.
PY - 2015/5/26
Y1 - 2015/5/26
N2 - In the present study the application of near-infrared chemical imaging (NIR-CI) supported by chemometric modeling as non-destructive tool for monitoring and assessing the roller compaction and tableting processes was investigated. Based on preliminary risk-assessment, discussion with experts and current work from the literature the critical process parameter (roll pressure and roll speed) and critical quality attributes (ribbon porosity, granule size, amount of fines, tablet tensile strength) were identified and a design space was established. Five experimental runs with different process settings were carried out which revealed intermediates (ribbons, granules) and final products (tablets) with different properties. Principal component analysis (PCA) based model of NIR images was applied to map the ribbon porosity distribution. The ribbon porosity distribution gained from the PCA based NIR-CI was used to develop predictive models for granule size fractions. Predictive methods with acceptable R2 values could be used to predict the granule particle size. Partial least squares regression (PLS-R) based model of the NIR-CI was used to map and predict the chemical distribution and content of active compound for both roller compacted ribbons and corresponding tablets. In order to select the optimal process, setting the standard deviation of tablet tensile strength and tablet weight for each tablet batch was considered. Strong linear correlation between tablet tensile strength and amount of fines and granule size was established, respectively. These approaches are considered to have a potentially large impact on quality monitoring and control of continuously operating manufacturing lines, such as roller compaction and tableting processes.
AB - In the present study the application of near-infrared chemical imaging (NIR-CI) supported by chemometric modeling as non-destructive tool for monitoring and assessing the roller compaction and tableting processes was investigated. Based on preliminary risk-assessment, discussion with experts and current work from the literature the critical process parameter (roll pressure and roll speed) and critical quality attributes (ribbon porosity, granule size, amount of fines, tablet tensile strength) were identified and a design space was established. Five experimental runs with different process settings were carried out which revealed intermediates (ribbons, granules) and final products (tablets) with different properties. Principal component analysis (PCA) based model of NIR images was applied to map the ribbon porosity distribution. The ribbon porosity distribution gained from the PCA based NIR-CI was used to develop predictive models for granule size fractions. Predictive methods with acceptable R2 values could be used to predict the granule particle size. Partial least squares regression (PLS-R) based model of the NIR-CI was used to map and predict the chemical distribution and content of active compound for both roller compacted ribbons and corresponding tablets. In order to select the optimal process, setting the standard deviation of tablet tensile strength and tablet weight for each tablet batch was considered. Strong linear correlation between tablet tensile strength and amount of fines and granule size was established, respectively. These approaches are considered to have a potentially large impact on quality monitoring and control of continuously operating manufacturing lines, such as roller compaction and tableting processes.
KW - Near-infrared chemical imaging
KW - Partial least squares
KW - Principal component analysis
KW - Ribbon chemical map
KW - Ribbon porosity map
KW - Roll compaction/dry granulation
KW - Tablet chemical map
UR - http://www.scopus.com/inward/record.url?scp=84930201473&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84930201473&partnerID=8YFLogxK
U2 - 10.1016/j.ejpb.2015.04.008
DO - 10.1016/j.ejpb.2015.04.008
M3 - Article
C2 - 25917640
AN - SCOPUS:84930201473
SN - 0939-6411
VL - 93
SP - 293
EP - 302
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
ER -