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The step-wise dissolution method: An efficient DSC-based protocol for verification of predicted API-polymer

Alex Mathers1, Matouš Pechar2, Fatima Hassouna2

  • 1Department of Physical Chemistry, University of Chemistry and Technology, Prague, Technická 5, 166 28 Prague 6, Czech Republic.

International Journal of Pharmaceutics
|November 19, 2023
PubMed
Summary

A new step-wise dissolution (S-WD) method improves amorphous solid dispersion (ASD) formulation by efficiently determining drug-polymer solubility. This cost-effective approach aids in creating stable ASDs with enhanced bioavailability.

Keywords:
Amorphous solid dispersionPC-SAFTPhase diagramSolid–liquid equilibriumSolubilityStep-wise dissolution

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Amorphous solid dispersions (ASDs) enhance the bioavailability of poorly water-soluble drugs.
  • Accurate temperature-composition (T-C) phase diagrams are crucial for stable ASD formulation.
  • Current methods for determining drug solubility in polymers are often inefficient and unreliable.

Purpose of the Study:

  • To evaluate the efficacy of a novel, cost- and time-effective step-wise dissolution (S-WD) method.
  • To assess the S-WD method's ability to verify predictions from the perturbed chain-statistical associating fluid theory (PC-SAFT) equation of state (EOS).
  • To optimize the S-WD protocol for reduced experimental effort in ASD development.

Main Methods:

  • Development and application of a novel differential scanning calorimetry (DSC)-based step-wise dissolution (S-WD) method.
  • Construction of fifteen active pharmaceutical ingredient (API)-polymer temperature-composition (T-C) phase diagrams.
  • Comparison of experimental S-WD results with predictions from the PC-SAFT equation of state (EOS).

Main Results:

  • The S-WD method reliably constructed fifteen API-polymer T-C phase diagrams.
  • Three distinct API-polymer interaction types were identified using the S-WD approach.
  • PC-SAFT EOS provided good qualitative agreement but lacked precise quantitative prediction of API solubility at 25°C.
  • A modified, optimal S-WD protocol was proposed to minimize experimental work.

Conclusions:

  • The S-WD method offers a more efficient and reliable alternative for determining API solubility in polymers for ASD formulation.
  • The optimized S-WD protocol significantly reduces experimental requirements.
  • This improved methodology facilitates the development of stable and effective amorphous solid dispersions.