TY - JOUR
T1 - Towards better process understanding
T2 - Chemometrics and multivariate measurements in manufacturing of solid dosage forms
AU - Matero, Sanni Elina
AU - van der Berg, Franciscus Winfried J
AU - Poutiainen, Sami
AU - Rantanen, Jukka
AU - Pekka Pajander, Jari
N1 - Copyright © 2013 Wiley Periodicals, Inc.
PY - 2013
Y1 - 2013
N2 - The manufacturing of tablets involves many unit operations that possess multivariate and complex characteristics. The interactions between the material characteristics and process related variation are presently not comprehensively analyzed due to univariate detection methods. As a consequence, current best practice to control a typical process is to not allow process-related factors to vary i.e. lock the production parameters. The problem related to the lack of sufficient process understanding is still there: the variation within process and material properties is an intrinsic feature and cannot be compensated for with constant process parameters. Instead, a more comprehensive approach based on the use of multivariate tools for investigating processes should be applied. In the pharmaceutical field these methods are referred to as Process Analytical Technology (PAT) tools that aim to achieve a thorough understanding and control over the production process. PAT includes the frames for measurement as well as data analyzes and controlling for in-depth understanding, leading to more consistent and safer drug products with less batch rejections. In the optimal situation, by applying these techniques, destructive end-product testing could be avoided. In this paper the most prominent multivariate data analysis measuring tools within tablet manufacturing and basic research on operations are reviewed.© 2013 Wiley-Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1385-1403, 2013.
AB - The manufacturing of tablets involves many unit operations that possess multivariate and complex characteristics. The interactions between the material characteristics and process related variation are presently not comprehensively analyzed due to univariate detection methods. As a consequence, current best practice to control a typical process is to not allow process-related factors to vary i.e. lock the production parameters. The problem related to the lack of sufficient process understanding is still there: the variation within process and material properties is an intrinsic feature and cannot be compensated for with constant process parameters. Instead, a more comprehensive approach based on the use of multivariate tools for investigating processes should be applied. In the pharmaceutical field these methods are referred to as Process Analytical Technology (PAT) tools that aim to achieve a thorough understanding and control over the production process. PAT includes the frames for measurement as well as data analyzes and controlling for in-depth understanding, leading to more consistent and safer drug products with less batch rejections. In the optimal situation, by applying these techniques, destructive end-product testing could be avoided. In this paper the most prominent multivariate data analysis measuring tools within tablet manufacturing and basic research on operations are reviewed.© 2013 Wiley-Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1385-1403, 2013.
U2 - 10.1002/jps.23472
DO - 10.1002/jps.23472
M3 - Review
C2 - 23423769
VL - 102
SP - 1385
EP - 1403
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
SN - 0022-3549
IS - 5
ER -