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Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

P Avalle1, M J Pollitt2, K Bradley2

  • 1MSD Werthenstein Biopharma, Industrie Nord, 1, Schachen (LU), Switzerland.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|February 8, 2014
PubMed
Summary
This summary is machine-generated.

This study optimized controlled release (CR) pellet manufacturing using Quality by Design (QbD) and Process Analytical Technology (PAT). Near-infrared (NIR) spectroscopy effectively monitored coating processes, ensuring critical quality attributes for better product performance.

Keywords:
Automated microscopyCoated multiparticulateDissolution performanceNear-infraredPelletQuality by Design

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology
  • Quality by Design

Background:

  • Controlled release (CR) pellet manufacturing requires precise control over coating processes.
  • Quality by Design (QbD) principles necessitate robust process understanding and control.
  • Process Analytical Technology (PAT) offers real-time monitoring capabilities for pharmaceutical manufacturing.

Purpose of the Study:

  • To develop and implement Process Analytical Technology (PAT) methods for controlling Wurster coating processes in CR pellet manufacturing.
  • To establish a link between near-infrared (NIR) spectra and critical quality attributes (CQAs) of the CR product.
  • To utilize automated microscopy as a reference method for PAT validation.

Main Methods:

  • Wurster coating of active pharmaceutical ingredient (API) onto sugar pellet cores.
  • Development of Process Analytical Technology (PAT) methods, including near-infrared (NIR) spectroscopy.
  • Application of automated microscopy as a reference method for process monitoring.
  • Chemometric analysis to correlate NIR spectra with coating weight, CR coating thickness, and dissolution performance.

Main Results:

  • Successful development of PAT methods for both API layering and CR coating steps.
  • Established correlations between NIR spectra and key parameters like coating weight, CR coating thickness, and dissolution performance.
  • Demonstrated the feasibility of at-line monitoring of the coating process using NIR spectroscopy.

Conclusions:

  • The developed PAT methods, particularly NIR spectroscopy, enable effective at-line monitoring of the CR pellet coating process.
  • This monitoring facilitates better control over critical quality attributes (CQAs), ensuring consistent product performance.
  • The integration of PAT within a QbD framework enhances the overall manufacturing control and product quality.