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Mechanochemically Induced Solid-State Transformations of Levofloxacin.

Lena Kadri1,2, Maria Carta3, Giulio Lampronti4

  • 1School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, College Green, Dublin 2 D02 PN40, Ireland.

Molecular Pharmaceutics
|April 25, 2024
PubMed
Summary
This summary is machine-generated.

Ball milling can partially amorphize levofloxacin hemihydrate (LVXh), forming an intermediate anhydrous form before complete amorphous levofloxacin (LVXam). Spray drying also achieves LVXam, showing amorphization is mechanism- and process-dependent.

Keywords:
ball millingfluoroquinolonekineticslevofloxacinmechanochemistryphase transformationspray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Solid-State Chemistry
  • Materials Science

Background:

  • Levofloxacin hemihydrate (LVXh) is a complex fluoroquinolone with multiple solid forms.
  • Understanding solid-state transformations is crucial for drug formulation and stability.

Purpose of the Study:

  • To investigate the amorphization capabilities and solid-state transformations of LVXh using ball milling.
  • To compare ball milling with spray drying for amorphous levofloxacin (LVXam) formation.
  • To elucidate the mechanism of LVXam formation via mechanical treatment.

Main Methods:

  • Ball milling and spray drying were employed for sample preparation.
  • Powder X-ray diffraction, thermal analysis, infrared spectroscopy, Rietveld refinement, and dynamic vapor sorption were used for characterization.
  • Kinetics and phase quantification were determined by Rietveld refinement.

Main Results:

  • Ball milling partially amorphized LVXh, proceeding through an intermediate anhydrous form (LVXγ) to LVXam.
  • A novel method for forming LVXγ and LVXam using mechanical forces was developed.
  • Spray drying from water achieved complete LVXam formation, with a glass transition temperature of 80 °C.

Conclusions:

  • LVXam formation is dependent on both the mechanism and the specific process used.
  • Both ball milling and spray drying methods yielded LVXam with comparable stability, crystallizing to the hemihydrate form.
  • This study enhances the understanding of fluoroquinolone solid-state transformations using sustainable manufacturing methods.