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Related Experiment Videos

Pellet manufacturing by extrusion-spheronization using process analytical technology.

Niklas Sandler1, Jukka Rantanen, Jyrki Heinämäki

  • 1Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki, PO Box 56, FIN-00014, Helsinki, Finland. niklas.sandler@helsinki.fi

AAPS Pharmscitech
|December 16, 2005
PubMed
Summary

This study examined phase transitions in nitrofurantoin and theophylline during pelletization using process analytical technology (PAT). Complementary techniques like Raman and XRPD confirmed API polymorphic changes, with drying temperature critical for dehydration.

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Process Analytical Technology (PAT)

Background:

  • Understanding solid-state behavior of Active Pharmaceutical Ingredients (APIs) during formulation is crucial for drug product quality.
  • Pelletization via extrusion-spheronization involves multiple stages where APIs can undergo physical changes.
  • Process Analytical Technology (PAT) offers real-time monitoring to enhance process understanding.

Purpose of the Study:

  • To investigate phase transitions in nitrofurantoin and theophylline formulations during extrusion-spheronization pelletization.
  • To evaluate the utility of an at-line PAT approach for monitoring solid-state API behavior.
  • To characterize polymorphic changes induced by processing and drying conditions.

Main Methods:

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  • Utilized Raman spectroscopy, near-infrared (NIR) spectroscopy, and X-ray powder diffraction (XRPD) for solid-state characterization.
  • Employed an at-line PAT strategy, collecting samples at various processing stages (blending, granulation, extrusion, spheronization, drying).
  • Investigated the effect of three drying temperatures (60°C, 100°C, 135°C) on API dehydration.

    • Main Results:

    • Water induced hydrate formation in both nitrofurantoin and theophylline formulations during wet processing stages.
    • NIR spectroscopy provided real-time water content data but could not detect hydrate formation due to signal saturation.
    • Raman and XRPD confirmed pseudopolymorphic changes, with dehydration dependent on hydrate type and drying temperature.

    Conclusions:

    • Complementary analytical techniques are essential for comprehensive understanding of API behavior during pelletization, especially when API and excipient signals overlap.
    • Drying temperature significantly impacts API dehydration, with channel hydrates (theophylline) dehydrating at lower temperatures than isolated site hydrates (nitrofurantoin).
    • PAT implementation requires careful selection of analytical methods to overcome limitations like signal saturation and low signal intensity for effective process monitoring.