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Process analytical technology for continuous manufacturing tableting processing: A case study.

Victoria Pauli1, Yves Roggo2, Laurent Pellegatti2

  • 1Novartis Pharma AG, Continuous Manufacturing (CM) Unit, CH-4002 Basel, Switzerland; Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstr. 1, 40225 Dusseldorf, Germany.

Journal of Pharmaceutical and Biomedical Analysis
|September 19, 2018
PubMed
Summary
This summary is machine-generated.

Near Infrared Spectroscopy (NIRS) enables rapid, non-destructive monitoring of continuous tableting processes. This study optimized NIRS for blend uniformity and API concentration, achieving high accuracy for real-time process control and release.

Keywords:
Blend uniformityContent uniformityContinuous manufacturingNear-infrared spectroscopyProcess analytical technologyTableting

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Area of Science:

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

Background:

  • Continuous manufacturing offers advantages in pharmaceutical production.
  • Real-time monitoring and control are crucial for ensuring product quality and process efficiency.
  • Near Infrared Spectroscopy (NIRS) is a rapid, non-destructive analytical technique suitable for in-line process monitoring.

Purpose of the Study:

  • To optimize and validate NIRS methods for in-line monitoring of blend uniformity and API concentration during continuous tableting.
  • To assess the performance and robustness of NIRS for process control.
  • To propose a comprehensive PAT strategy for continuous manufacturing.

Main Methods:

  • Development and optimization of two NIRS methods for in-line analysis.
  • Utilizing Partial Least Square (PLS) regression for quantitative analysis.
  • Employing qualitative methods (single wavelength, PCA, ICA) for process monitoring at different development stages.
  • Achieving high spectral acquisition speeds (up to 70,000 tablets/h).

Main Results:

  • Excellent predictive calibration results with a coefficient of correlation (r) of 0.99 for both probes.
  • Low errors in calibration (RMSEC) and prediction (RMSEP) for API content (1.8%) and tablet content (2.2%).
  • Demonstrated robustness and performance of the developed NIRS methods.
  • Validation of qualitative approaches for early-stage development and foundation for quantitative methods.

Conclusions:

  • The optimized NIRS methods provide accurate and rapid in-line control of the tableting process.
  • The proposed PAT strategy is effective for continuous manufacturing, supporting real-time release.
  • NIRS is a valuable tool for ensuring quality and efficiency in pharmaceutical tableting processes.