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Predicting Drug Loading Capacity for PLA-Amorphous Drug System Using Hansen Solubility Parameters.

Artūrs Paulausks1,2, Artjoms Iljičevs1, Jurga Bernatoniene3,4

  • 1Laboratory of Finished Dosage Forms, Faculty of Pharmacy, Rīga Stradiņš University, LV-1007 Riga, Latvia.

Pharmaceutics
|March 28, 2026
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Summary
This summary is machine-generated.

Hansen solubility parameters (HSPs) effectively predict drug miscibility in polymers, enabling the creation of saturated amorphous drug phases. This method offers a novel approach for selecting drug-polymer combinations and determining amorphous saturation concentrations.

Keywords:
HPLCPLAXRDamorphous solid dispersionsdrug loadingsolubility parameterssolvent castingvacuum compression moulding

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Area of Science:

  • Materials Science
  • Pharmaceutical Sciences
  • Physical Chemistry

Background:

  • Predicting drug-polymer miscibility is crucial for developing amorphous solid dispersions.
  • Hansen solubility parameters (HSPs) offer a theoretical framework for understanding molecular interactions.

Purpose of the Study:

  • To investigate the utility of HSPs in predicting drug miscibility with polymers for creating saturated amorphous drug phases.
  • To establish a quantitative correlation between drug concentration and HSPs.

Main Methods:

  • HSPs were determined for polylactic acid (PLA) and 12 model drugs using the Yamamoto molecular break (Y-MB) group contribution method (GCM) and solvent experiments.
  • Drug-loaded PLA samples were prepared via solvent casting (SC) and vacuum compression moulding (VCM) with increasing drug concentrations.
  • Amorphous drug phase and concentration were confirmed using X-ray diffraction and High-Performance Liquid Chromatography (HPLC).

Main Results:

  • A statistically significant linear correlation (R² values 0.85–0.93) was observed between drug concentration and linearized HSP distance for both SC and VCM methods.
  • Achieved saturated amorphous drug loads were confirmed, demonstrating the practical application of the HSP approach.

Conclusions:

  • HSPs can be effectively applied to predict miscible drug-polymer pairs for amorphous solid dispersion formulations.
  • This methodology provides a valuable tool for estimating the amorphous saturation concentration of drugs in polymers.