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Simultaneous XRD-DSC identifies correct drug-polymer solubility and miscibility for enantiotropic solid forms.

Mustafa Bookwala1, Jiawanjun Shi2, Ira S Buckner1

  • 1School of Pharmacy and Graduate School of Pharmaceutical Sciences, Duquesne University, 600 Forbes Ave, Pittsburgh, PA 15282, USA.

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Simultaneous X-ray diffraction (XRD) and differential scanning calorimetry (DSC) accurately determined thermodynamic properties for bromopropamide solid forms. This combined technique avoids misinterpretations often seen with DSC alone, crucial for amorphous solid dispersion stability.

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Area of Science:

  • Solid-state chemistry
  • Materials science
  • Pharmaceutical sciences

Background:

  • Amorphous solid dispersions (ASDs) enhance drug solubility and bioavailability.
  • Physical stability of ASDs is strongly linked to drug-polymer thermodynamic properties like solubility and miscibility.
  • Bromopropamide exhibits complex solid forms, necessitating precise characterization for stable ASD formulation.

Purpose of the Study:

  • To characterize the thermodynamic properties of bromopropamide's complex solid forms.
  • To evaluate the utility of simultaneous X-ray diffraction (XRD)-differential scanning calorimetry (DSC) for assessing drug-polymer interactions.
  • To compare the accuracy of combined XRD-DSC with DSC alone for determining solid form transitions and miscibility.

Main Methods:

  • Simultaneous XRD-DSC measurements were performed on bromopropamide and its mixtures with polyvinylpyrrolidone-vinyl acetate random copolymer (PVPVA).
  • Crystallization and structure solution of the most stable bromopropamide solid form.
  • Determination of dissolution endpoint (Tend) for various drug-polymer compositions using XRD-DSC.
  • Comparative analysis of thermodynamic data obtained from combined XRD-DSC versus DSC alone.

Main Results:

  • Simultaneous XRD-DSC successfully identified unique diffraction patterns corresponding to different bromopropamide solid forms during heating.
  • Accurate measurements of the dissolution endpoint (Tend) were achieved across a wide range of bromopropamide-PVPVA compositions.
  • Combined XRD-DSC provided reliable data for estimating drug-polymer solubility and miscibility, crucial for ASD physical stability.
  • Analysis revealed that DSC data alone can lead to ambiguous or incorrect conclusions regarding solid forms and their transitions.

Conclusions:

  • Simultaneous XRD-DSC is a powerful and accurate technique for characterizing complex solid forms and their thermodynamic properties.
  • This combined method enhances the understanding of drug-polymer miscibility and solubility, vital for developing stable amorphous solid dispersions.
  • The study highlights the limitations of using DSC alone for complex systems, emphasizing the need for complementary techniques like XRD for reliable solid-state analysis.