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Active pharmaceutical ingredient (API) production involving continuous processes--a process system engineering

Albert E Cervera-Padrell1, Tommy Skovby, Søren Kiil

  • 1Department of Chemical and Biochemical Engineering, Technical University of Denmark (DTU), Kgs. Lyngby, Denmark.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|July 24, 2012
PubMed
Summary
This summary is machine-generated.

A new framework integrates continuous flow technologies and process systems engineering for designing pharmaceutical manufacturing. This approach accelerates process development, enhances understanding, and reduces environmental impact, as shown in a zuclopenthixol API case study.

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Area of Science:

  • Chemical Engineering
  • Pharmaceutical Manufacturing
  • Process Systems Engineering

Background:

  • Traditional batch pharmaceutical manufacturing faces challenges in efficiency and process understanding.
  • Designing active pharmaceutical ingredient (API) synthetic processes requires a systematic approach to manage complexity.
  • Integrating novel technologies like continuous flow is crucial for modernizing drug production.

Purpose of the Study:

  • To propose a systematic framework for designing continuous pharmaceutical manufacturing processes.
  • To leverage continuous flow technologies and Process Systems Engineering (PSE) for faster process design and deeper understanding.
  • To guide the transition from early drug discovery to detailed process design, optimizing for cost and environmental footprint.

Main Methods:

  • Development of a systematic design framework integrating continuous flow (e.g., microfluidics) and PSE tools.
  • Application of the framework to structure design challenges from solvent selection to purification.
  • Utilizing literature examples of PSE methods in pharmaceutical process design and novel production technologies.

Main Results:

  • The framework successfully guided the retrofit of a batch API process (zuclopenthixol) to continuous mode.
  • Achieved higher yields and significant process simplification.
  • Reduced the process mass intensity (material and environmental footprint) by 50%, with potential for further improvements.

Conclusions:

  • The proposed framework effectively facilitates the design and optimization of continuous pharmaceutical manufacturing.
  • Continuous processing offers significant advantages in yield, efficiency, and sustainability.
  • The framework is applicable to both novel and existing API manufacturing processes.