Reference : Design space approach in the optimization of the spray-drying process
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/100593
Design space approach in the optimization of the spray-drying process
English
Lebrun, Pierre mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Krier, Fabrice mailto [Université de Liège - ULg > Département de pharmacie > Pharmacie galénique >]
Mantanus, Jérôme mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Grohganz, Holger [ > > ]
Yang, Mingshi [ > > ]
Rozet, Eric mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Evrard, Brigitte [Université de Liège - ULg > Département de pharmacie > Pharmacie galénique >]
Rantanen, Jukka [ > > ]
Hubert, Philippe mailto [Université de Liège - ULg > Département de pharmacie > Chimie analytique >]
2012
European Journal of Pharmaceutics & Biopharmaceutics
Elsevier Science
80
1
226-234
Yes
International
0939-6411
Amsterdam
The Netherlands
[en] Spray-drying ; design of experiments ; quality by design ; risk-based design space ; Critical Quality Attributes ; specifications ; Bayesian statistical predictive methodology ; multivariate regression ; process optimization
[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.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/100593

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