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Systematic evaluations regarding interparticular mass transfer in spheronization.

Martin Koester1, Emilie Willemsen, Cornelia Krueger

  • 1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Duesseldorf, Germany.

International Journal of Pharmaceutics
|May 2, 2012
PubMed
Summary

This study reveals that direct material transfer between rounding pellets, not just breakage, significantly impacts pharmaceutical pellet formation during extrusion-spheronization. Pelletization aids like microcrystalline cellulose (MCC) influence this mass transfer more than carrageenan.

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Extrusion-spheronization is key for pharmaceutical pellet production, yielding spherical shapes and narrow size distributions.
  • Existing models for pellet formation primarily focus on breakage and deformation, neglecting inter-particle interactions.

Purpose of the Study:

  • To investigate the evolution of pellet properties during spheronization over time.
  • To quantify the influence of inter-pellet interactions, specifically mass transfer, on pellet properties.
  • To assess the impact of different pelletization aids on these interactions.

Main Methods:

  • Investigated acetaminophen and lactose pellets using common pelletization aids: microcrystalline cellulose type I (MCCI), microcrystalline cellulose type II (MCCII), and kappa-carrageenan.
  • Monitored the fine particle fraction and inter-pellet mass transfer throughout the spheronization process.

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  • Quantified mass transfer percentages for each pelletization aid.

    • Main Results:

    • A high initial fine fraction decreased over time, with simultaneous increases in inter-pellet material transfer.
    • Observed mass transfer exceeded that explainable by the fine fraction alone, suggesting direct particle-to-particle transfer.
    • Kappa-carrageenan resulted in lower mass transfer (15%) compared to MCCI and MCCII (up to 25%).

    Conclusions:

    • Direct inter-pellet material transfer is a significant, previously underestimated mechanism in extrusion-spheronization.
    • Pelletization aids critically influence the extent of mass transfer, impacting final pellet properties.
    • Understanding these interactions is crucial for optimizing pharmaceutical pellet manufacturing.