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Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
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Solid lipid budesonide microparticles for controlled release inhalation therapy.

Matteo Mezzena1, Santo Scalia, Paul M Young

  • 1Department of Pharmaceutical Sciences, Ferrara University, 44121, Ferrara, Italy.

The AAPS Journal
|November 13, 2009
PubMed
Summary
This summary is machine-generated.

This study developed solid lipid microparticles for budesonide delivery, showing potential for controlled respiratory therapy. These particles offer a novel approach compared to conventional crystalline and amorphous budesonide formulations.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Conventional budesonide formulations face challenges in achieving optimal controlled release for respiratory therapy.
  • Solid lipid microparticles (SLMs) offer a promising alternative drug delivery system due to their biocompatibility and potential for sustained release.

Purpose of the Study:

  • To prepare and characterize a novel solid lipid microparticle system containing budesonide.
  • To evaluate the morphology, particle characteristics, aerosol performance, and in vitro release profile of budesonide SLMs.
  • To compare the budesonide SLMs with conventional crystalline and amorphous budesonide formulations.

Main Methods:

  • Oil-in-water emulsification followed by spray drying was employed to create budesonide-loaded SLMs.
  • Characterization included analysis of morphology, particle size distribution (laser diffraction), crystallinity (X-ray powder diffraction), thermal properties (Differential Scanning Calorimetry), aerosol performance (multistage liquid impinger), and in vitro dissolution/diffusion (flow-through cell).
  • Formulations were compared using difference/similarity factors and fitted to the Higuchi model for release kinetics.

Main Results:

  • SLMs exhibited irregular morphology, with similar particle size distributions to crystalline and amorphous budesonide.
  • Thermal analysis indicated budesonide integration within the glycerol behenate lipid matrix, with no drug crystallization or melting peaks observed.
  • Solid lipid microparticles demonstrated a significantly longer dissolution time (t½ = 136.9 min) compared to crystalline (49.7 min) and amorphous (35.3 min) budesonide.
  • Aerosol performance for particles <5 micrometers was 21.1% for SLMs, versus 29.5% for crystalline and 27.3% for amorphous budesonide.

Conclusions:

  • Solid lipid microparticles successfully incorporated budesonide, forming a stable matrix.
  • The SLM formulation exhibited distinct in vitro release characteristics and aerosol performance compared to conventional budesonide forms.
  • This study suggests that solid lipid microparticles represent a viable strategy for developing controlled-release budesonide formulations for respiratory applications.