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Continuous Twin-Screw Granulation Processing

In: Optimization of Pharmaceutical Processes

Author

Listed:
  • Uttom Nandi

    (University of Greenwich
    CIPER Centre for Innovation and Process Engineering Research)

  • Tumpa Dey

    (University of Greenwich
    CIPER Centre for Innovation and Process Engineering Research)

  • Dennis Douroumis

    (University of Greenwich
    CIPER Centre for Innovation and Process Engineering Research)

Abstract

Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest for the development of oral dosage forms. The technology has evolved rapidly due to the flexibility of the equipment design, the selection of the process variables and the wide range of processed materials. Most importantly, TSG offers the benefits of both batch and continuous manufacturing for pharmaceutical products accompanied with excellent process control, high product quality which can be achieved through the implementation of quality by design (QbD) approaches and the integration of process analytical technologies (PAT). Here we present the basic concepts of the various twin-screw granulation techniques and present in detail their advantages and disadvantages. In addition, we discuss the detail of the instrumentation used for TSG and how the critical processing parameters (CPPs) affect the critical quality attributes (CQAs) of the produced granules. Finally, we present recent advances in TSG continuous manufacturing including paradigms of QbD approaches coupled with PAT monitoring for granule optimisation and process understanding.

Suggested Citation

  • Uttom Nandi & Tumpa Dey & Dennis Douroumis, 2022. "Continuous Twin-Screw Granulation Processing," Springer Optimization and Its Applications, in: Antonios Fytopoulos & Rohit Ramachandran & Panos M. Pardalos (ed.), Optimization of Pharmaceutical Processes, pages 135-169, Springer.
    • Handle: RePEc:spr:spochp:978-3-030-90924-6_6
    DOI: 10.1007/978-3-030-90924-6_6
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