TY - JOUR
T1 - Building quality into a coating process
AU - Naelapaa, Kaisa
AU - Veski, Peep
AU - Kristensen, Henning Gjelstrup
AU - Rantanen, Jukka Tapio
AU - Bertelsen, Poul
PY - 2010/2
Y1 - 2010/2
N2 - An effective approach towards optimal development strategy is to use the quality by design principle. However, this approach can first be implemented when possible risks impacting critical quality attributes are defined and interactions between those are fully understood. The objective of this study was to identify critical variables that affect the final modified release product performance using a risk management approach with supporting statistical tool. After risk ranking and filtering a full mixed factorial experimental design of coating experiments was performed. Experimental design clearly indicated that studied critical processes parameters have a great impact on coat integrity and hence on drug release.
AB - An effective approach towards optimal development strategy is to use the quality by design principle. However, this approach can first be implemented when possible risks impacting critical quality attributes are defined and interactions between those are fully understood. The objective of this study was to identify critical variables that affect the final modified release product performance using a risk management approach with supporting statistical tool. After risk ranking and filtering a full mixed factorial experimental design of coating experiments was performed. Experimental design clearly indicated that studied critical processes parameters have a great impact on coat integrity and hence on drug release.
U2 - 10.3109/10837450902882377
DO - 10.3109/10837450902882377
M3 - Journal article
C2 - 19694502
SN - 1083-7450
VL - 15
SP - 35
EP - 45
JO - Pharmaceutical Development and Technology
JF - Pharmaceutical Development and Technology
IS - 1
ER -