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Parameter optimization in a continuous direct compression process of commercially batch-produced bisoprolol tablets.

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  • 1School of Pharmacy, PromisLab, University of Eastern Finland, Kuopio, Finland.

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|November 7, 2022
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Summary

Continuous direct compression successfully transferred tablet manufacturing from batch processes. This method achieved desired tablet quality using the original formulation, overcoming material challenges.

Keywords:
Continuous powder blendingMulti-tip punchesPaddle speedPharmaceutical continuous manufacturingProcess conversionTableting

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering

Background:

  • Traditional batch manufacturing is being challenged by continuous manufacturing for tablets.
  • Technology transfer from batch to continuous processes requires careful evaluation.

Purpose of the Study:

  • To assess technology transfer from batch to continuous direct compression for a commercial tablet formulation.
  • To maintain the original formulation composition during the transfer.

Main Methods:

  • Powder characterization of raw materials.
  • Tableting studies using multi-tip punches.
  • Process parameter optimization (force feeder and mixer impeller RPM) using experimental design.
  • Long-term tableting run (3 hours) to evaluate optimized parameters.

Main Results:

  • Tablet weight variability was significantly reduced through process parameter optimization.
  • Optimized settings enabled adequate control of tablet weights within specification criteria.
  • Tablets produced via continuous direct compression met all quality criteria, comparable to batch-produced tablets.
  • Successful production was achieved despite challenging powder flowability.

Conclusions:

  • Continuous direct compression is a viable alternative to batch manufacturing for this tablet formulation.
  • Technology transfer is achievable without altering the original formulation composition.
  • Process optimization is key to managing material challenges in continuous manufacturing.