Application of DEM to understand, predict, and de-risk segregation in the manufacturing of pharmaceutical drug products
William Ketterhagen, AbbVie
The successful manufacture of oral solid drug products in the pharmaceutical industry is dependent upon meeting a number of criteria that help ensure quality products are made available to patients. One criterion is achievement of sufficient distribution and uniformity of the active drug substance across the dosage forms. As such, powder blending processes must be designed to sufficiently mix disparate raw materials within the formulation. Further, subsequent processing and powder transfer operations must not induce significant segregation of the well-mixed blend. In this presentation, application of the discrete element method (DEM) to examine blending and segregating systems is described, including application to bin blending processes, bin discharge, chute transfer, and powder flow through rotary tablet press feed frames. In each of these cases, the simulations can used to better inform engineering insight of the process, make decisions to guide process development, and de-risk process scale-up.
Bill Ketterhagen is a Principal Research Engineer in the Process Engineering Sciences group within AbbVie Research and Development in North Chicago, IL. He has extensive experience in developing and implementing predictive models and engineering solutions in support of pharmaceutical drug product development. He has driven the use of materials characterization and small-scale experimentation to ensure models are parameterized and validated with robust experimental data. These combined experimental / modeling predictive approaches have been applied across drug product processing operations, including the areas of powder storage and handling, feeding, granulation, and film coating processes, amongst others. Bill has published work in numerous peer-reviewed papers and invited presentations at national and international conferences. Bill earned a B.S. in Chemical Engineering from the University of Wisconsin – Madison and a Ph.D. in Chemical Engineering from Purdue University.