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Model-Based Scale-Up Methodologies for Pharmaceutical Granulation.

Eun Ha Jang1, Yun Sang Park2, Min-Soo Kim3

  • 1Department of Pharmaceutical Engineering, Inje University, Gyeongnam 621749, Korea.

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Summary

Scaling up pharmaceutical manufacturing processes, especially granulation, presents quality challenges. This study reviews three model-based scale-up methods—engineering, process analytical technology, and physics-based—to ensure consistent drug product quality.

Keywords:
PAT-based modelingengineering-based modelingpharmaceutical granulationphysics-based modelingscale-up

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Scale-up

Background:

  • Maintaining consistent drug product quality during batch scale changes (lab to commercial) is a significant pharmaceutical industry challenge.
  • Pharmaceutical processes involve multiple unit operations (blending, granulation, milling, tableting, coating), where process parameters critically impact final drug quality.
  • Granulation is particularly sensitive to scale variations due to changes in process parameters and equipment geometry.

Purpose of the Study:

  • To present model-based scale-up methodologies specifically for pharmaceutical granulation processes.
  • To review and summarize existing data and applications of these scale-up methods.
  • To provide a systematic strategy for ensuring drug product quality during scale-up.

Main Methods:

  • Engineering-based modeling: Utilizes dimensionless numbers derived from process similarity principles.
  • Process Analytical Technology (PAT)-based modeling: Employs real-time monitoring of process product quality attributes for flexible parameter adjustment.
  • Physics-based modeling: Involves process simulation using physical principles to predict drug quality by calculating process behavior.

Main Results:

  • The study details three distinct model-based approaches for addressing scale-up challenges in pharmaceutical granulation.
  • Applications of these methods are summarized across different granulation mechanisms, including wet and dry granulation.
  • The effectiveness of these methodologies in ensuring consistent drug product quality is highlighted.

Conclusions:

  • Model-based scale-up methodologies offer a systematic approach to managing process variations during pharmaceutical manufacturing.
  • These methods are crucial for maintaining critical quality attributes of drug products across different batch scales.
  • The reviewed approaches provide a robust framework for pharmaceutical companies to achieve consistent quality in scaled-up granulation processes.