Pedro Cardoso Valentea
a Hovione Farmaciência S.A., R&D Center, Campus do Lumiar, Edifício S, 1649-038 Lisboa, Portugal
We explore lean, model-based, process development strategies for the blending unit operations in continuous direct compression (CDC). The main function of the continuous blending operation is to micro-mix the ingredients and filter out any disturbances from the loss-in-weigh feeders and thus enables the process to operate continuously from dosing to tablet compression.
We present case-studies with different modelling approaches that reduce the number of experiments and material consumption need to develop and optimize the blending process. These different modelling approaches have varying degrees of complexity and range from mechanistic to first principles models based on Discrete Element Methods (Figure 1).
We also discuss the prospect of enabling the next generation of lean process development relying solely on raw material analytical characterization and discuss the main scientific questions that need to be addressed to enable this objective.
Figure 1 – Discrete Element Method simulation of powder blending.
Dr. Pedro Valente is the Director of Oral Drug Product Development at Hovione R&D specializing in formulation, particle engineering and process development of pharmaceutical drug products. Prior to joining Hovione, Pedro was an invited Lecturer and Researcher at the University of Lisbon covering the areas of Fluid Mechanics and Turbulence. Previously he was an aero-thermodynamics engineer at Volvo Aero Corp. (now GKN aerospace). Pedro Valente holds a Ph.D. from Imperial College London, U.K. in Aeronautics and MScs from the U. Lisbon, Portugal (Mech. Eng.) and from Chalmers Technical University, Sweden (Turbulence).
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