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A commentary on scale-up of pan coating process using microenvironmental control.

Preetanshu Pandey1, Dilbir S Bindra1

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Summary

Traditional scale-up rules for aqueous pan-coating often fail. A new real-time monitoring tool tracks thermodynamic changes, ensuring process consistency and successful scale-up for sensitive systems.

Keywords:
EEF factorcoatingmicroenvironmentprocess analytical technology (PAT)processingquality by design (QbD)scale-upsolid dosage formunit operations

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Aqueous pan-coating processes have established scale-up rules.
  • Small-scale experiments do not always predict large-scale outcomes accurately.
  • Gaps exist in traditional scale-up methodologies.

Purpose of the Study:

  • To review traditional scale-up methods for aqueous pan-coating.
  • To identify limitations in current scale-up rules.
  • To introduce a novel real-time monitoring tool for scale-up.

Main Methods:

  • Review of existing scale-up strategies.
  • Identification of discrepancies between small and large-scale results.
  • Application of a real-time process monitoring tool.

Main Results:

  • Traditional scale-up rules have limitations.
  • The new monitoring tool provides real-time thermodynamic data.
  • This tool helps maintain equivalent process conditions during scale-up.

Conclusions:

  • Real-time monitoring of thermodynamic changes is crucial for successful scale-up.
  • The new tool enhances scale-up success, particularly for thermodynamically sensitive systems.
  • Ensuring environmentally equivalent conditions improves process reproducibility.