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Engineered particles demonstrate improved flow properties at elevated drug loadings for direct compression

Andrea N Trementozzi1, Cheuk-Yui Leung1, Frederick Osei-Yeboah1

  • 1Biogen, Cambridge, MA 02142, United States.

International Journal of Pharmaceutics
|March 13, 2017
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Summary

Particle engineering of active pharmaceutical ingredients (APIs) significantly improves powder flow for tablet manufacturing. This study shows engineered APIs enhance blend flowability without compromising tablet quality, crucial for pharmaceutical development.

Keywords:
Compaction profileFlow functionParticle morphologyParticle size distributionPermeability

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Optimizing powder flow and compaction is vital for robust tablet manufacturing, especially for high-dose formulations and process scale-up.
  • The properties of the active pharmaceutical ingredient (API) significantly influence blend performance.

Purpose of the Study:

  • To investigate the impact of API particle engineering on powder flow and compaction properties.
  • To evaluate the effect of particle size on blend tabletability at elevated drug loadings.

Main Methods:

  • Comparison of jet-milled API (D50=24μm) with wet-milled APIs (D50=70μm, 90μm).
  • Assessment of powder flow functions (ffc) and blend tabletability.
  • Analysis of powder blends with excipients.

Main Results:

  • All API lots exhibited poor flow (ffc<4) despite particle size differences.
  • Wet-milled API blends showed significantly improved flow functions (ffc>10) after adding excipients.
  • Both jet-milled and wet-milled materials produced robust tablets at high drug loadings.

Conclusions:

  • API particle engineering can enhance powder blend flowability without negatively impacting tabletability.
  • The study challenges the direct correlation between particle size and powder flow, highlighting the role of excipients.
  • Findings are critical for early-phase pharmaceutical development and API selection, especially with material-sparing techniques.