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Continuous Processing of Micropellets via Hot-Melt Extrusion.

Martin Spoerk1, Ioannis Koutsamanis2, Andreas Kottlan3

  • 1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010, Graz, Austria. martin.spoerk@rcpe.at.

AAPS Pharmscitech
|September 27, 2022
PubMed
Summary

This study introduces a novel, solvent-free method for creating small micropellets (MPs) for injections using continuous hot-melt extrusion. The process allows for on-the-fly formulation changes and produces injectable particles comparable to marketed products.

Keywords:
biodegradablecontrolled-releasedrug deliverymicroparticlepolymer

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Process Engineering

Background:

  • Microparticulate drug delivery systems, such as micropellets (MPs), are crucial in pharmaceutical formulations like suspensions and injectables.
  • Current manufacturing relies on batch, solvent-based methods (e.g., spray-drying), which have limitations.

Purpose of the Study:

  • To develop and evaluate a novel, solvent-free, continuous hot-melt extrusion process for producing small micropellets for injectable applications.
  • To demonstrate the potential for on-the-fly formulation changes and applicability to challenging formulations.

Main Methods:

  • Utilized continuous hot-melt extrusion with inline cold pelletization.
  • Employed a biodegradable poly(DL-lactic acid) (PLA) dispersion with metformin as the model drug.
  • Conducted particle analyses, in-line high-speed camera investigations, and injectability testing.

Main Results:

  • Achieved small particle size distribution (d50 < 270 µm) and aspect ratios near 1 with fast extrusion speeds and multiple pelletizer knives.
  • Determined that the drug particle size (d90) must be significantly smaller than the extrudate diameter to ensure stretchability and enable small MP production.
  • Demonstrated comparable injectability to a marketed formulation after adjusting syringe diameter.

Conclusions:

  • The proposed solvent-free, continuous hot-melt extrusion process is a viable method for manufacturing novel microparticulate formulations for injection.
  • This approach offers advantages in particle size control, formulation flexibility, and potential for scalable production.