Building quality into a coating process.
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.
Naelapää
Kaisa
K
Department of Pharmaceutics and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark. kn@farma.ku.dk
Veski
Peep
P
Kristensen
Henning Gjelstrup
HG
Rantanen
Jukka
J
Bertelsen
Poul
P
D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry / Q000592:standards*; D004339:Drug Compounding / Q000592:standards*; D018570:Risk Assessment / Q000379:methods; D012308:Risk Management; D012995:Solubility; D013678:Technology, Pharmaceutical
D003692:Delayed-Action Preparations; C013517:ethyl cellulose; D002482:Cellulose