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Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral

Md Anik Alam1, Yang Angela Liu1, Stephanie Dolph1

  • 1Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA.

International Journal of Pharmaceutics
|April 11, 2021
PubMed
Summary
This summary is machine-generated.

A novel Near Infrared (NIR) method quantifies Saccharin potency in powder blends during continuous manufacturing. This material-sparing approach uses a benchtop system for robust calibration across sites and scales.

Keywords:
CalibrationContinuous manufacturingDirect compressionNear infraredPotency monitoringProcess Analytical TechnologyRobustness

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Area of Science:

  • Pharmaceutical Manufacturing
  • Analytical Chemistry
  • Process Analytical Technology (PAT)

Background:

  • Continuous manufacturing offers advantages in pharmaceutical production.
  • Real-time monitoring of Active Pharmaceutical Ingredient (API) potency is crucial for process control.
  • Traditional calibration methods can be resource-intensive.

Purpose of the Study:

  • To develop and validate a Near Infrared (NIR) method for quantifying Saccharin potency.
  • To demonstrate the utility of a benchtop feed frame system for material-sparing calibration.
  • To assess the robustness of the NIR method across different manufacturing sites and instruments.

Main Methods:

  • A 15-point Design of Experiments (DoE) was employed to create a calibration set.
  • Partial Least Square (PLS) modeling was used for quantitative NIR method development.
  • The method was validated across five test batches at two manufacturing sites.

Main Results:

  • The developed NIR method accurately quantified Saccharin potency in powder blends.
  • The method demonstrated robustness against variations in process scale and NIR instrumentation.
  • Effective calibration was achieved using minimal material (0.5 kg Saccharin surrogate).

Conclusions:

  • A benchtop feed frame system enables efficient, material-sparing calibration for NIR methods.
  • The developed NIR method is suitable for real-time potency monitoring in continuous manufacturing.
  • This approach facilitates cross-site and cross-instrument method transfer for pharmaceutical processes.