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Related Experiment Videos

Cohesive, multicomponent, dense powder flow characterization by NIR.

C Benedetti1, N Abatzoglou, J-S Simard

  • 1Université de Sherbrooke, Department of Chemical Engineering, Sherbrooke, Que., Canada J1K 2R1.

International Journal of Pharmaceutics
|January 24, 2007
PubMed
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This study developed a near-infrared spectroscopy (NIR) method for real-time powder flow characterization in pharmaceutical manufacturing. The process analytical technology (PAT) tool accurately monitors active pharmaceutical ingredient (API) levels in flowing blends.

Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Process Engineering

Background:

  • Non-aerated powder flow is critical in pharmaceutical manufacturing, impacting final product quality.
  • Powder agglomeration or segregation during flow can compromise solid oral dosage forms.
  • Developing in-line monitoring for powder flow characteristics is essential for process control.

Purpose of the Study:

  • To develop a Process Analytical Technology (PAT) method for in-line powder flow characterization.
  • To utilize near-infrared spectroscopy (NIR) for real-time analysis of pharmaceutical powder blends.
  • To quantitatively determine the active pharmaceutical ingredient (API) level in flowing powder formulations.

Main Methods:

  • Assembled a bench-scale hopper system to monitor powder flow.

Related Experiment Videos

  • Employed an in-line commercial NIR spectrometer and probe for spectral data collection.
  • Developed a partial least squares (PLS) chemometric model using laboratory-prepared samples.

    • Main Results:

    • Achieved high reproducibility for static and flowing pure mannitol spectra.
    • The PLS model demonstrated a low standard error of calibration (2.95% of API level) and high R2 (0.991).
    • API estimates from flowing blend spectra were statistically acceptable and consistent with model predictions.

    Conclusions:

    • The developed NIR-based PAT method is promising for in-line powder flow characterization.
    • The method accurately quantifies API levels in flowing pharmaceutical blends.
    • Further improvements could lead to the adoption of this PAT tool at a production scale.