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Processes 2018, 6(9), 154; https://doi.org/10.3390/pr6090154

Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology

1
98 Brett Rd., Department of Chemical and Biochemical Engineering, Rutgers-The State University of New Jersey, Piscataway, NJ 08854, USA
2
Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ 08854, USA
Currently at Kura Oncology Inc., Drug Product Development, 3033 Science Park Rd., San Diego, CA 92121, USA.
*
Author to whom correspondence should be addressed.
Received: 15 June 2018 / Revised: 2 August 2018 / Accepted: 21 August 2018 / Published: 1 September 2018
(This article belongs to the Special Issue Process Modelling and Simulation)
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Abstract

An experimental study in industry was previously carried out on a batch fluid bed granulation system by varying the inlet fluidizing air temperature, binder liquid spray atomization pressure, the binder liquid spray rate and the disintegrant composition in the formulation. A population balance model framework integrated with heat transfer and moisture balance due to liquid addition and evaporation was developed to simulate the fluid bed granulation system. The model predictions were compared with the industry data, namely, the particle size distributions (PSDs) and geometric mean diameters (GMDs) at various time-points in the granulation process. The model also predicted the trends for binder particle dissolution in the wetting liquid and the temperatures of the bed particles in the fluid bed granulator. Lastly, various process parameters were varied and extended beyond the region studied in the aforementioned experimental study to identify optimal regimes for granulation. View Full-Text
Keywords: fluid bed granulation; heat and mass balance; population balance model; binder dissolution; kernel development fluid bed granulation; heat and mass balance; population balance model; binder dissolution; kernel development
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Muddu, S.V.; Tamrakar, A.; Pandey, P.; Ramachandran, R. Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology. Processes 2018, 6, 154.

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