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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Nonclassical Crystallization and Core-Shell Structure Formation of Ibuprofen from Binary Solvent Solutions.

Rajaboopathi Mani1,2, Leena Peltonen3, Clare J Strachan3

  • 1Department of Chemical and Metallurgical Engineering, Aalto University, FI-00076 Aalto (Espoo), Finland.

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Summary

Liquid-liquid phase separation (LLPS) forms dense liquid intermediates in ibuprofen crystallization. This nonclassical pathway leads to core-shell structures, enhancing drug dissolution and offering new crystallization insights.

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Area of Science:

  • Crystallization Science
  • Pharmaceutical Science
  • Materials Science

Background:

  • Liquid-liquid phase separation (LLPS) is common in pharmaceutical crystallization but its role in nucleation is unclear.
  • Nonclassical crystallization pathways, including LLPS, are increasingly recognized for their impact on crystal formation.
  • Understanding intermediate phases is crucial for controlling pharmaceutical crystallization and drug properties.

Purpose of the Study:

  • To investigate the role of dense liquid intermediates in ibuprofen crystallization.
  • To elucidate the molecular ordering and structural evolution during nonclassical crystallization of ibuprofen.
  • To explore the formation mechanism of core-shell ibuprofen crystals originating from LLPS.

Main Methods:

  • Raman spectroscopy to analyze molecular ordering and interactions in the dense phase.
  • Small-angle X-ray scattering (SAXS) to determine cluster sizes in solution and dense phases.
  • Focused-ion beam (FIB) imaging to visualize the core-shell structure and nanoparticle attachment.

Main Results:

  • Formation of a dense liquid intermediate followed by ibuprofen core-shell crystals via nonclassical crystallization.
  • Raman spectra indicated intermolecular interactions in the dense phase similar to the solid state.
  • SAXS data confirmed differences in cluster sizes between the supersaturated solution and the dense phase.
  • FIB imaging revealed nanoparticle attachment and a proposed mechanism for dense phase to core-shell transformation.

Conclusions:

  • LLPS intermediates play a significant role in alternative nucleation mechanisms for ibuprofen crystallization.
  • The transformation from a dense liquid phase to a core-shell structure involves internal dissolution or reversed crystal growth.
  • The observed LLPS intermediate and subsequent core-shell structure offer a new perspective on ibuprofen crystallization and dissolution enhancement.