title: Building quality into a coating process.
abstract: 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.
authors.affiliation: Department of Pharmaceutics and Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark. kn@farma.ku.dk
authors.forename: Kaisa
authors.initials: K
authors.lastname: Naelapää
authors.forename: Peep
authors.initials: P
authors.lastname: Veski
authors.forename: Henning Gjelstrup
authors.initials: HG
authors.lastname: Kristensen
authors.forename: Jukka
authors.initials: J
authors.lastname: Rantanen
authors.forename: Poul
authors.initials: P
authors.lastname: Bertelsen
mesh_terms: 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
chemical_list: D003692:Delayed-Action Preparations; C013517:ethyl cellulose; D002482:Cellulose