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A Scalable Balz-Schiemann Reaction Protocol in a Continuous Flow Reactor
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Multi-scale flowsheet simulation of an integrated continuous purification-downstream pharmaceutical manufacturing

Maitraye Sen1, Anwesha Chaudhury, Ravendra Singh

  • 1Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA.

International Journal of Pharmaceutics
|February 6, 2013
PubMed
Summary

Continuous manufacturing uses process modeling to link active pharmaceutical ingredient (API) properties to final tablet quality. Understanding API crystallization impacts downstream powder mixing and tablet attributes, enhancing quality by design (QbD).

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Area of Science:

  • Chemical Engineering
  • Pharmaceutical Manufacturing
  • Process Systems Engineering

Background:

  • Active pharmaceutical ingredient (API) properties critically affect solid dosage form quality attributes (CQAs).
  • Continuous manufacturing offers a promising alternative to traditional batch processing in the pharmaceutical industry.
  • Quantitative modeling is essential for understanding upstream API characteristics' impact on downstream processing and ensuring Quality by Design (QbD).

Purpose of the Study:

  • To present a dynamic flowsheet simulation of an integrated API purification and downstream processing.
  • To quantitatively analyze how upstream API properties influence downstream processing quality metrics.
  • To demonstrate the coupling of particle-scale and process-scale information for enhanced simulation dynamics.

Main Methods:

  • Dynamic flowsheet simulation integrating API crystallization, filtration, drying, and powder mixing.
  • Utilized a hybrid Population Balance Model (PBM) and Discrete Element Method (DEM) model.
  • Analyzed the influence of crystallization temperature profiles on crystal size distribution (CSD).

Main Results:

  • The crystallization temperature profile significantly impacts CSD.
  • CSD directly influences the relative standard deviation (RSD) and API concentration in powder mixing.
  • Powder mixing quality metrics have a direct effect on final tablet properties.

Conclusions:

  • Process modeling provides a quantitative link between API properties and downstream quality metrics.
  • Understanding crystallization dynamics is key to controlling powder mixing and tablet attributes in continuous manufacturing.
  • Hybrid PBM-DEM modeling enhances the elucidation of integrated pharmaceutical process dynamics.