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Single processing step toward injectable sustained-release formulations of Triptorelin based on a novel degradable

Lutz R Asmus1, Béatrice Kaufmann, Louise Melander

  • 1School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland. Lutz.Asmus@unige.ch

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
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Summary

Hexyl-substituted poly(lactic acid) (hexPLA) offers a liquid alternative for injectable peptide formulations, simplifying administration and enabling controllable long-term drug release.

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Area of Science:

  • Polymer Science
  • Pharmaceutical Formulation
  • Drug Delivery

Background:

  • Poly(lactic acid) (PLA) is a common polymer for sustained-release injections, but its solid nature requires complex formulations.
  • Hexyl-substituted PLA (hexPLA) is a liquid alternative, simplifying the formulation of injectable suspensions.

Purpose of the Study:

  • To evaluate the feasibility of hexPLA as a liquid carrier for injectable peptide formulations.
  • To compare formulation procedures and characterize Triptorelin-hexPLA suspensions for sustained release.

Main Methods:

  • Investigated a one-step cryo-milling-mixing process for peptide incorporation into hexPLA.
  • Assessed peptide particle size, distribution, rheology, and in vitro drug release.
  • Analyzed hexPLA degradation by monitoring molecular weight and weight loss.

Main Results:

  • A simple cryo-milling-mixing method yielded homogeneous Triptorelin-hexPLA formulations with small peptide particle sizes (4.1 μm).
  • Formulations exhibited thixotropic and shear-thinning behavior, with viscosity dependent on drug loading, molecular weight, and temperature.
  • All tested formulations demonstrated sustained release of Triptorelin for over 3 months, controllable via drug loading and hexPLA molecular weight.

Conclusions:

  • HexPLA is a promising liquid carrier for injectable peptide formulations, simplifying preparation and enabling tunable long-term release.
  • Further research into drug-polymer interactions and in vivo performance is warranted.