From compression to coating: FEM and DEM simulations for continuous tablet manufacturing
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In-silico simulations are becoming essential tools in pharmaceutical product development, offering an innovative approach to accelerate development and improve process understanding. This talk highlights the application and challenges of numerical modelling, i.e., the Finite Element Method (FEM) and the Discrete Element Method (DEM), to key stages of oral solid dosage development, including Residence Time prediction, tableting and liquid film coating. In tableting, FEM was applied as a qualitative tool to evaluate stress and density distribution within tablets. The tool provides insight into mechanical strength and defect formation based on compression process, tablet design and formulation. Current models face challenges in quantitative validation and to account for air entrapment. For continuous manufacturing, DEM simulations were employed to predict the residence time distribution (RTD) in the full scale ConsiGma 25 line [1] and using pharmaceutical powders which are challenging to model due to size and cohesiveness. The model predictions were compared to experimental data. For tablet coating, ongoing activities focus on Discrete Element Method coupled with Discrete Droplet Method to model liquid film coating and to predict intra-tablet and inter-tablet coating variability, with validation experiments currently ongoing. These case studies demonstrate the potential of simulations to support digital transformation in pharmaceutical manufacturing. However, significant effort is still required to reach the level of accuracy and robustness necessary for the models to meet pharmaceutical industry and regulatory expectations.
