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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Process Modeling and Simulation of Tableting-An Agent-Based Simulation Methodology for Direct Compression.

Niels Lasse Martin1,2, Ann Kathrin Schomberg2,3, Jan Henrik Finke2,3

  • 1Institute of Machine Tools and Production Technology (IWF), Technische Universität Braunschweig, Langer Kamp 19b, 38106 Braunschweig, Germany.

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Summary
This summary is machine-generated.

This study introduces an agent-based simulation model for predicting active pharmaceutical ingredient (API) tablet structures. This novel approach enhances tracking and tracing in pharmaceutical manufacturing processes.

Keywords:
agent-based modeling and simulationprocess modeling and simulationproduct structures and characteristicstableting

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Computational Modeling

Background:

  • Reliable production of high-quality pharmaceutical products is paramount.
  • Simulation and digital twins offer virtual experimentation for process planning and operation.
  • Industrial tablet production involves complex, interdependent sub-processes affecting material structure and properties.

Purpose of the Study:

  • To present a novel agent-based simulation model for predicting structures and properties in industrial tableting.
  • To demonstrate the methodology for developing product and process agents in agent-based simulations.
  • To enable prediction, tracking, and tracing of intermediate structures and properties during API tableting.

Main Methods:

  • Development of an agent-based simulation model incorporating physical models.
  • Identification and development of product and process agents.
  • Experimental characterization of pilot-scale rotary press tablet production for calibration and validation.

Main Results:

  • The agent-based simulation model successfully predicts the structures of intermediate products in tableting.
  • Physical models within the simulation effectively describe the impact of process parameters on material structures.
  • Simulation predictions of final tablet structures were validated against experimental data.

Conclusions:

  • Agent-based simulation provides a powerful tool for predicting and understanding pharmaceutical tableting processes.
  • The developed methodology enables accurate tracking and tracing of material structures and properties.
  • This approach supports enhanced quality control and process optimization in pharmaceutical manufacturing.