Journal
POWDER TECHNOLOGY
Volume 354, Issue -, Pages 199-210Publisher
ELSEVIER
DOI: 10.1016/j.powtec.2019.05.078
Keywords
Flowsheet modeling; Pharmaceutical manufacturing; Sensitivity analysis; Continuous manufacturing; Continuous direct compression
Categories
Funding
- U.S. Food and Drug Administration (USFDA)United States of America cooperate research project, Process Modeling and Assessment Tools for Simulation, Risk Management and Design Space Development of Integrated Pharmaceutical Manufacturing Processes [5U01FD005294]
- Merck & Co., Inc., Kenilworth, NJ USA
- Merck & Co., Inc., (Kenilworth, NJ USA)
- USFDA
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A flowsheet model for a continuous direct compression tableting process is developed and applied to process data generated at production scale. The model contains powder feeding, blending and tablet compaction unit operations. The dataset was provided by Merck & Co., Inc., Kenilworth, NJ USA using a GEA ConsiGma (TM) continuous direct compression process designed for approximately 50 kg/h throughput using a six ingredient, potentially commercial, formulation. A tanks-in-series methodology is used to model the transport of powders through the blending units and a number of tablet compaction equations are selectable which can illustrate how upstream changes in composition are propagated to tablet properties. The flowsheet model performed well based on the available dataset with accurate predictions of API concentration and tablet hardness. Monte Carlo simulations were used along with the flowsheet model to investigate the contribution of feeder flowrate variability to measurement noise and the sensitivity of tablet hardness to process parameters and material properties. (C) 2019 Published by Elsevier B.V.
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