Design space approach in the optimization of the spray-drying process.pdf

European Journal of Pharmaceutics and Biopharmaceutics 80 (2012) 226–234 Contents lists available at SciVerse ScienceDirect European Journal of Pharmaceutics and Biopharmaceutics journal homepage: /locate/ejpb Research paper Design space approach in the optimization of the spray-drying process ? Pierre Lebrun a,d, , Fabrice Krier b, Jér?me Mantanus a, Holger Grohganz c, Mingshi Yang c, Eric Rozet a, Bruno Boulanger d, Brigitte Evrard b, Jukka Rantanen c, Philippe Hubert a a Laboratory of Analytical Chemistry, CIRM, University of Liège, Liège, Belgium b Laboratory of Pharmaceutical Technology, CIRM, University of Liège, Liège, Belgium c Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen, Copenhagen, Denmark d Arlenda, Liège, Belgium article info abstract Article history: From a quality by design perspective, the aim of the present study was to demonstrate the applicability of Received 12 July 2011 a Bayesian statistical methodology to identify the Design Space (DS) of a spray-drying process. Following Accepted in revised form 22 September the ICH Q8 guideline, the DS is de?ned as the ‘‘multidimensional combination and interaction of input 2011 variables (e.g., materials attributes) and process parameters that have been demonstrated to provide Available online 29 September 2011 assurance of quality.’’ Thus, a predictive risk-based approach was set up in order to account for the uncer- tainties and correlations found in the process and in the derived critical quality attributes such as the Keywords: