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Polymorphism in Solid Dispersions.

Karina Sanabria Ortiz1,2, José R Hernández Espinell1,2, Desire Ortiz Torres1,2

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The preparation method significantly impacts the polymorphic form of solid dispersions. Fusion methods yield mixed polymorphs, while solvent-based methods produce a single crystalline form, crucial for accurate phase diagrams and drug quality.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Solid dispersions enhance drug solubility by embedding active pharmaceutical ingredients (APIs) within polymeric carriers.
  • Common preparation techniques include solvent evaporation, solvent-fusion, and fusion methods.
  • These techniques are often used for phase diagram determination, but their impact on API polymorphism is understudied.

Purpose of the Study:

  • To investigate the influence of different preparation methods on the polymorphic form of crystalline solid dispersions (CSDs).
  • To analyze the effect of preparation techniques on phase diagram determination for flufenamic acid (FFA) and poly(ethylene glycol) (PEG) systems.

Main Methods:

  • Preparation of crystalline solid dispersions (CSDs) using solvent evaporation, solvent-fusion, and fusion methods.
  • Characterization of physical mixtures and CSDs using powder X-ray diffraction (PXRD), infrared spectroscopy (IR), and differential scanning calorimetry (DSC).

Main Results:

  • The fusion method resulted in concomitant polymorphs of flufenamic acid (FFA I and FFA III) in the CSDs.
  • Solvent evaporation and solvent-fusion methods predominantly yielded the FFA III polymorph.
  • Preparative methods significantly influenced phase diagram determination, with an average relative deviation of less than or equal to 8%.

Conclusions:

  • The choice of preparation method critically affects the polymorphic outcome of solid dispersions.
  • Accurate phase diagram determination, essential for process design and quality control, depends on selecting appropriate preparation techniques.
  • Understanding the influence of preparation methods on polymorphism ensures the critical quality attributes of pharmaceutical formulations.