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Acceleration of Final Residual Solvent Extraction From Poly(lactide-co-glycolide) Microparticles.

Florian Kias1, Roland Bodmeier2

  • 1College of Pharmacy, Freie Universität Berlin, Kelchstr. 31, 12169, Berlin, Germany.

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Summary

Aqueous and alcoholic wet extraction effectively removed dichloromethane from poly(D,L-lactic-co-glycolic acid) microparticles. Alcoholic extraction followed by aqueous extraction and vacuum drying yielded the best results for residual solvent removal.

Keywords:
microparticlesplasticizationpoly(lactide-co-glycolide)solvent extractionsolvent residuals

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Biodegradable poly(D,L-lactic-co-glycolic acid) (PLGA) microparticles are widely used in drug delivery systems.
  • Residual solvents, such as dichloromethane, must be removed to meet safety and regulatory standards.
  • Efficient removal of residual solvents is crucial for maintaining the integrity and performance of microparticle formulations.

Purpose of the Study:

  • To investigate the efficacy of different methods for removing residual dichloromethane from PLGA microparticles.
  • To compare aqueous wet extraction, alcoholic wet extraction, and vacuum-drying techniques.
  • To evaluate the impact of extraction conditions on microparticle properties and drug encapsulation.

Main Methods:

  • PLGA microparticles were prepared using the oil-in-water (O/W) solvent extraction/evaporation method.
  • Residual dichloromethane was quantified using gas chromatography and Karl Fischer titration.
  • Microparticle aggregation, surface morphology, and drug loading (dexamethasone, risperidone) were assessed post-extraction.

Main Results:

  • Aqueous wet extraction at 35°C reduced dichloromethane to 0.03% (w/w).
  • Vacuum-drying alone was less effective, leaving higher residual solvent levels.
  • Alcoholic wet extraction, particularly with methanol or ethanol/water mixtures, significantly enhanced dichloromethane removal, reducing it to <0.18% (w/w) within 6 hours.
  • Higher alcohol concentrations and temperatures led to microparticle aggregation and reduced drug loading.

Conclusions:

  • Alcoholic wet extraction followed by aqueous wet extraction at elevated temperatures and vacuum drying is the most efficient method for removing residual dichloromethane from PLGA microparticles.
  • Optimizing extraction conditions is essential to balance solvent removal with microparticle integrity and drug payload.
  • Understanding solvent-plasticizer interactions, guided by the Gordon-Taylor equation and Hansen solubility parameters, is key to developing effective purification strategies.