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Related Experiment Videos

Scale-up of a pan-coating process.

Preetanshu Pandey1, Richard Turton, Nitin Joshi

  • 1Department of Chemical Engineering, West Virginia University, Morgantown, WV, USA.

AAPS Pharmscitech
|February 9, 2007
PubMed
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This study presents practical scale-up rules for solvent-based pan-coating, simplifying process control. These rules ensure consistent drug release and membrane characteristics across different equipment sizes.

Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Process Scale-up

Background:

  • Solvent-based pan-coating is crucial for pharmaceutical tablet formulation.
  • Scaling up coating processes presents challenges in maintaining product quality.
  • Existing scale-up models often require complex experimentation and parameter prediction.

Purpose of the Study:

  • To develop a practical and simplified scale-up model for solvent-based pan-coating.
  • To establish key process parameters for effective coating control during scale-up.
  • To validate the proposed scale-up rules through experimental testing.

Main Methods:

  • Development of scale-up rules based on macroscopic evaluation of the coating process.
  • Conducting scale-up and scale-down experiments using 24-inch and 52-inch coating equipment.

Related Experiment Videos

  • Analyzing cumulative drug release profiles and membrane characteristics (opacity, roughness).
  • Investigating the impact of process variables on coat weight uniformity and membrane properties.

    • Main Results:

    • The proposed scale-up rules successfully maintained similar cumulative drug release profiles (f2 >> 50) across different scales.
    • Membrane characteristics, including opacity and roughness, were consistent between the 24-inch and 52-inch scales.
    • Pan speed was identified as the most significant factor influencing coating uniformity.
    • Spray droplet size and drying capacity were found to significantly affect membrane roughness and opacity, respectively.

    Conclusions:

    • The developed practical scale-up model effectively facilitates the transition of solvent-based pan-coating processes to larger equipment.
    • The proposed rules simplify scale-up by avoiding complex experimentation and parameter prediction.
    • Consistent product quality, demonstrated by drug release profiles and membrane attributes, is achievable across scales using these guidelines.