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Novel Gliclazide Electrosprayed Nano-Solid Dispersions: Physicochemical Characterization and Dissolution Evaluation.

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  • 1Research Center for Pharmaceutical Nanotechnology and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.

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Electrospraying successfully created amorphous solid dispersions of gliclazide, a poorly water-soluble drug, significantly improving its dissolution rate. This novel technique enhances drug delivery for BCS Class II medications.

Keywords:
Amorphous solid dispersionsElectrosprayEudragit® RS100GliclazideIn vitro evaluationNanocrystallinePolyethylene glycol 6000

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Gliclazide (GLC) is a poorly water-soluble drug (BCS Class II) requiring formulation strategies to enhance its bioavailability.
  • Developing amorphous solid dispersions (ESSs) is a key approach to improve the dissolution of such drugs.

Purpose of the Study:

  • To investigate electrospraying as a novel method for preparing gliclazide amorphous solid dispersions (ESSs).
  • To evaluate the physicochemical properties and in vitro drug release of the developed ESSs.
  • To determine the drug release mechanism from the optimized formulations.

Main Methods:

  • Electrospraying of gliclazide with Eudragit® RS100 and polyethylene glycol (PEG) 6000 at various ratios and concentrations.
  • Characterization using Field Emission Scanning Electron Microscopy (FESEM), Differential Scanning Calorimetry (DSC), Powder X-ray Diffraction (PXRD), and Fourier-Transform Infrared Spectroscopy (FTIR).
  • In vitro drug release studies and kinetic modeling (Weibull model).

Main Results:

  • Electrospraying produced nanosized/amorphous solid dispersions, with morphology influenced by drug:polymer ratio and solution concentration.
  • Amorphous state of gliclazide within the solid dispersions was confirmed by DSC and PXRD.
  • Formulations with PEG 6000 significantly enhanced gliclazide dissolution rate.
  • Weibull model best described the release profile, indicating Fickian diffusion as the primary mechanism.
  • FTIR suggested potential complexation or hydrogen bonding between gliclazide and polymers.

Conclusions:

  • Electrospraying is an effective technique for producing amorphous solid dispersions of poorly water-soluble drugs like gliclazide.
  • The developed ESSs exhibit improved physicochemical properties and enhanced in vitro dissolution.
  • This method holds promise for formulating BCS Class II drugs, improving their therapeutic efficacy.