Building quality into a coating process

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 -