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Process analytical technology: application to particle sizing in spray drying.

L W Chan1, L H Tan, Paul W S Heng

  • 1GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.

AAPS Pharmscitech
|May 1, 2008
PubMed
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Process Analytical Technology (PAT) effectively sizes particles during spray drying. An at-line laser diffraction system provided the most accurate microsphere size measurements, accounting for agglomerates.

Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Materials Science

Background:

  • Spray drying is a widely used technique for producing microparticles.
  • Accurate particle size characterization is crucial for controlling product performance.
  • Process Analytical Technology (PAT) offers potential for real-time monitoring.

Purpose of the Study:

  • To evaluate Process Analytical Technology (PAT) for particle sizing during spray drying.
  • To compare in-line and at-line laser diffraction with off-line methods.
  • To assess the suitability of PAT for microsphere production.

Main Methods:

  • Microspheres were produced using maltodextrin and modified starch.
  • Particle size was measured using in-line, at-line, and off-line laser diffraction.

Related Experiment Videos

  • Light microscopy was used for comparative morphological analysis and sizing.

    • Main Results:

    • In-line laser diffraction overestimated particle size due to agglomerates.
    • At-line and off-line laser diffraction showed better correlation with individual microsphere sizes.
    • Light microscopy provided morphological detail but was less efficient for sizing.

    Conclusions:

    • PAT is a valuable tool for spray drying particle sizing, but requires careful data interpretation.
    • Agglomerate formation significantly impacts in-line measurements.
    • The at-line laser diffraction setup demonstrated greater suitability for this application.