Mathematical Model for Development and Robustness Evaluation of Fluidised Bed Drying Processes
Pfizer GmbH, Arzneimittelwerk Gödecke, Freiburg/Breisgau
Correspondence: Dr.-Ing. Mads Grünberg, Verdunstr. 28, 28211 Bremen (Germany), e-mail: firstname.lastname@example.org*)
Fluidised bed technology is commonly used in the pharmaceutical industry for drying of granulations. The objective of the following work is to derive a mathematical model, which is able to predict the product moisture content and the exhaust air temperature during fluidised bed drying processes. At low product moisture contents, this is often very challenging. To overcome this problem it is suggested to incorporate adsorption isotherm models. It was found that for the aqueous granulation studied the best results were achieved by using the Guggenheim- Anderson-de Boer (GAB) isotherm. The mathematical model can be used to aid process development and robustness testing. The science-based approach may potentially support design space filings of new pharmaceutical products.
*) New address; author is no longer affiliated with Pfizer GmbH, Arzneimittelwerk Gödecke, Freiburg/Breisgau (Germany).
Key words Computer-aided process development • Design space • Fluidised bed drying, GAB isotherm, mathematical model, process robustness
pharmind 2008, Nr. 10, Seite 1239