Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets
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Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets. / Fonteyne, Margot; Wickström, Henrika; Peeters, Elisabeth; Vercruysse, Jurgen; Ehlers, Henrik; Peters, Björn-Hendrik; Remon, Jean Paul; Vervaet, Chris; Ketolainen, Jarkko; Sandler, Niklas; Rantanen, Jukka; Naelapää, Kaisa; Beer, Thomas De.
In: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, Vol. 87, No. 2, 28.02.2014, p. 252-263.Research output: Contribution to journal › Journal article › peer-review
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TY - JOUR
T1 - Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets
AU - Fonteyne, Margot
AU - Wickström, Henrika
AU - Peeters, Elisabeth
AU - Vercruysse, Jurgen
AU - Ehlers, Henrik
AU - Peters, Björn-Hendrik
AU - Remon, Jean Paul
AU - Vervaet, Chris
AU - Ketolainen, Jarkko
AU - Sandler, Niklas
AU - Rantanen, Jukka
AU - Naelapää, Kaisa
AU - Beer, Thomas De
N1 - Copyright © 2014 Elsevier B.V. All rights reserved.
PY - 2014/2/28
Y1 - 2014/2/28
N2 - Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of raw material attributes, manufacturing process options and process parameters. This fits further into the Process Analytical Technology (PAT) and Quality by Design (QbD) framework. The present study evaluates the effect of variation in critical raw material properties on the critical quality attributes of granules and tablets, produced by a continuous from-powder-to-tablet wet granulation line. The granulation process parameters were kept constant to examine the differences in the end product quality caused by the variability of the raw materials properties only. Theophylline-Lactose-PVP (30-67.5-2.5%) was used as model formulation. Seven different grades of theophylline were granulated. Afterward, the obtained granules were tableted. Both the characteristics of granules and tablets were determined. The results show that differences in raw material properties both affect their processability and several critical quality attributes of the resulting granules and tablets.
AB - Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of raw material attributes, manufacturing process options and process parameters. This fits further into the Process Analytical Technology (PAT) and Quality by Design (QbD) framework. The present study evaluates the effect of variation in critical raw material properties on the critical quality attributes of granules and tablets, produced by a continuous from-powder-to-tablet wet granulation line. The granulation process parameters were kept constant to examine the differences in the end product quality caused by the variability of the raw materials properties only. Theophylline-Lactose-PVP (30-67.5-2.5%) was used as model formulation. Seven different grades of theophylline were granulated. Afterward, the obtained granules were tableted. Both the characteristics of granules and tablets were determined. The results show that differences in raw material properties both affect their processability and several critical quality attributes of the resulting granules and tablets.
U2 - 10.1016/j.ejpb.2014.02.011
DO - 10.1016/j.ejpb.2014.02.011
M3 - Journal article
C2 - 24589422
VL - 87
SP - 252
EP - 263
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
SN - 0939-6411
IS - 2
ER -
ID: 104572739