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Structural characterization and developability assessment of sustained release hydrogels for rapid implementation

Prashant Agarwal1, Daniel G Greene1, Scott Sherman1

  • 1Drug Product Technologies, Process Development, Amgen, Inc., 360 Binney St, Cambridge, MA 02142, United States.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|December 28, 2020
PubMed
Summary

Commercially available hydrogels using poly(lactic-co-glycolic acid) (PLGA) and poly(lactide-co-caprolactone) (PLCL) effectively delayed lysozyme release for over 20 days. Their structural properties confirmed diffusion as the primary release mechanism, highlighting their preclinical development potential.

Keywords:
HydrogelsMesh SizePLCLPLGARheologySAXSSustained Release

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Area of Science:

  • Biomaterials Science
  • Drug Delivery Systems
  • Polymer Chemistry

Background:

  • Sustained-release formulations are crucial for developing effective therapeutics.
  • Hydrogels offer a rapid method for assessing sustained-release strategies, especially in preclinical settings with limited drug quantities.
  • Existing research often prioritizes new material synthesis over structural characterization and technological implementation.

Purpose of the Study:

  • To evaluate two commercially available thermosensitive hydrogel systems for sustained drug delivery.
  • To characterize the structural properties of poly(lactic-co-glycolic acid)-b-poly(ethylene glycol)-b-poly(lactic-co-glycolic acid) (PLGA) and poly(lactide-co-caprolactone)-b-poly(ethyleneglycol)-b-poly(lactide-co-caprolactone) (PLCL) hydrogels.
  • To determine the mechanism controlling lysozyme release from these hydrogel systems.

Main Methods:

  • Formulation of PLGA and PLCL block copolymers into thermosensitive hydrogels.
  • In vitro assessment of lysozyme release kinetics over an extended period (> 20 days).
  • Characterization of hydrogel properties including sol-gel transition temperature, complex viscosity, injection force, and gel mesh size using small angle X-ray scattering (SAXS) and rheology.

Main Results:

  • Both PLGA and PLCL hydrogels successfully delayed lysozyme release for over 20 days.
  • Hydrogel mesh sizes were larger than the hydrodynamic radius of lysozyme, indicating diffusive release.
  • PLGA hydrogels exhibited higher complex viscosity than PLCL hydrogels, correlating with slower lysozyme diffusion and release.
  • In vitro release experiments confirmed diffusion as the dominant release mechanism, unaffected by degradation, erosion, or swelling.

Conclusions:

  • Thermosensitive PLGA and PLCL hydrogels are suitable for sustained drug delivery in preclinical studies.
  • The structural characteristics of the hydrogels, particularly mesh size and viscosity, dictate the release rate of therapeutics.
  • Understanding hydrogel network structure is critical for controlling drug release and optimizing formulation design for sustained therapeutic effects.