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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Comparative Study of DSC-Based Protocols for API-Polymer Solubility Determination.

Alex Mathers1, Fatima Hassouna2, Martin Klajmon1

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

Molecular Pharmaceutics
|March 3, 2021
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Summary

Determining active pharmaceutical ingredient (API) solubility in polymers is crucial for amorphous solid dispersions. A new step-wise dissolution (S-WD) method using differential scanning calorimetry (DSC) accurately predicts API solubility at storage temperatures.

Keywords:
PC-SAFTamorphous solid dispersiondifferential scanning calorimetryphase diagramsolid−liquid equilibriumsolubility

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Area of Science:

  • Materials Science
  • Pharmaceutical Sciences
  • Physical Chemistry

Background:

  • Accurate active pharmaceutical ingredient (API) solubility in polymers is essential for amorphous solid dispersion (ASD) formulation.
  • Determining API solubility at storage temperatures is challenging, impacting ASD stability and efficacy.
  • Differential scanning calorimetry (DSC) is a key technique for solubility assessment.

Purpose of the Study:

  • To evaluate and compare various DSC-based methods for determining API solubility in polymers.
  • To develop and validate a novel 'step-wise dissolution' (S-WD) method for enhanced accuracy.
  • To predict the solubility of Indomethacin (IND) in Kollidon 12 PF (PVP K12) at storage temperature.

Main Methods:

  • Comparison of three established DSC methods: melting point depression (MPD), recrystallization, and zero-enthalpy extrapolation (Z-EE).
  • Development and application of the novel step-wise dissolution (S-WD) method.
  • Utilized Gordon-Taylor and Kwei equations for glass-transition temperature, and Flory-Huggins, empirical, and PC-SAFT models for solid-liquid equilibrium.

Main Results:

  • Established DSC methods (recrystallization, MPD, Z-EE) overestimated IND solubility due to annealing time, endotherm evaluation, and heating rate limitations.
  • The S-WD method, combined with the Kwei equation and PC-SAFT EOS, provided the most reliable solubility prediction.
  • Predicted IND solubility in PVP K12 at 25 °C was approximately 40 wt %.

Conclusions:

  • The S-WD method offers a more accurate and reliable approach for determining API solubility in polymers compared to traditional DSC methods.
  • The S-WD method is cost- and time-effective, requiring fewer samples and compositions.
  • Accurate solubility data is critical for optimizing amorphous solid dispersion formulations.