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Related Concept Videos

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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249
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
249

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Towards a novel continuous HME-Tableting line: Process development and control concept.

Stephan Sacher1, Selma Celikovic2, Jakob Rehrl1

  • 1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.

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Summary

This study developed a novel continuous tablet manufacturing line using hot melt extrusion (HME) and direct compaction (DC). Advanced control strategies were implemented for automated feedback control, enhancing pharmaceutical production efficiency.

Keywords:
Advanced process controlContinuous manufacturingControl conceptDirect compactionHot melt extrusionModel predictive controlPat strategy

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Drug Delivery Systems

Background:

  • Continuous manufacturing offers advantages in pharmaceutical production.
  • Hot melt extrusion (HME) and direct compaction (DC) are key technologies for advanced formulations.
  • Automated control is crucial for robust continuous processes but remains challenging.

Purpose of the Study:

  • To develop a novel closed-loop controlled continuous tablet manufacturing line.
  • To integrate HME for pellet production and DC for tableting.
  • To implement advanced control strategies for automated feedback control.

Main Methods:

  • Developed a continuous manufacturing line combining HME and DC.
  • Implemented Proportional Integral Derivative (PID) controllers for blend concentration, strand temperature, and pellet thickness.
  • Utilized a model predictive controller (MPC) for tablet press hopper level control.
  • Simulated different master unit control concepts for mass flow rate coordination.

Main Results:

  • Successfully implemented closed-loop control for key process parameters.
  • Demonstrated automated feedback control for intermediate and product quality attributes.
  • Evaluated various master unit configurations for mass flow rate control via simulation.

Conclusions:

  • The developed continuous manufacturing line with integrated HME and DC is controllable.
  • Advanced control strategies, including PID and MPC, are effective for automated pharmaceutical production.
  • The study provides insights into master unit selection for mass flow rate coordination in continuous lines.