Article (Scientific journals)
Design space approach in the optimization of the spray-drying process
Lebrun, Pierre; Krier, Fabrice; Mantanus, Jérôme et al.
2012In European Journal of Pharmaceutics and Biopharmaceutics, 80 (1), p. 226-234
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Keywords :
Spray-drying; design of experiments; quality by design; risk-based design space; Critical Quality Attributes; specifications; Bayesian statistical predictive methodology; multivariate regression; process optimization
Abstract :
[en] From a quality by design perspective, the aim of the present study was to demonstrate the applicability of a Bayesian statistical methodology to identify the design space (DS) of a spray-drying process. Following the ICH Q8 guideline, the DS is defined as the “multidimensional combination and interaction of input variables (e.g., materials attributes) and process parameters that have been demonstrated to provide assurance of quality”. Thus, a predictive risk-based approach was set up in order to account for the uncertainties and correlations found in the process and in the derived critical quality attributes such as the yield, the moisture content, the inhalable fraction of powder, the compressibility index and the Hausner ratio. This allowed quantifying the guarantees and the risks to observe whether the process shall run according to specifications. These specifications describe satisfactory quality outputs and were defined a priori given safety, efficiency and economical reasons. Within the identified DS, validation of the optimal condition was effectuated. The optimized process was shown to perform as expected, providing a product for which the quality is built in by the design and controlled set-up of the equipment, regarding identified critical process parameters: the inlet temperature, the feed rate and the spray flow rate.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Lebrun, Pierre ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Krier, Fabrice ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Mantanus, Jérôme ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Grohganz, Holger
Yang, Mingshi
Rozet, Eric ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Boulanger, Bruno ;  Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Evrard, Brigitte  ;  Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Rantanen, Jukka
Hubert, Philippe  ;  Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
Design space approach in the optimization of the spray-drying process
Publication date :
2012
Journal title :
European Journal of Pharmaceutics and Biopharmaceutics
ISSN :
0939-6411
eISSN :
1873-3441
Publisher :
Elsevier Science, Amsterdam, Netherlands
Volume :
80
Issue :
1
Pages :
226-234
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 23 October 2011

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