Instant Formulation of Inhalable Beclomethasone Dipropionate-Gamma-Cyclodextrin Composite Particles Produced Using...

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Medical composites require advanced formulation techniques for effective drug delivery.
• Gamma-cyclodextrin (γ-CD) and beclomethasone dipropionate (BDP) are key components for pulmonary applications.
• Supercritical-assisted atomization (SAA) offers potential for novel particle engineering.

Purpose of the Study:

• To synthesize and characterize medical composites of γ-CD and BDP using SAA.
• To optimize SAA parameters for enhanced particle properties and aerosol performance.
• To evaluate the in vitro aerosolization and dissolution of the drug composites.

Main Methods:

• Synthesis of γ-CD/BDP composites via supercritical-assisted atomization (SAA) using CO2 and ethanol.
• Optimization of SAA parameters including solvent composition, temperature, pressure, and flow rates.
• Characterization of particle morphology, aerosol performance (fine particle fraction), and dissolution profiles.
• Inclusion complex formation between BDP and γ-CD was investigated.

Main Results:

• Optimized SAA conditions (50% ethanol, specific temperatures, CO2/γ-CD ratio of 1.8, leucine) yielded fine spherical particles with superior aerosol performance.
• BDP solubility increased due to inclusion complex formation with γ-CD, enhanced by ethanol.
• Higher γ-CD-to-BDP ratios (Z) resulted in increased fine particle fraction.
• Dissolution rate positively correlated with γ-CD content, indicating improved drug release.

Conclusions:

• SAA is a viable technique for producing γ-CD/BDP medical composites for pulmonary delivery.
• Optimized formulations demonstrate enhanced aerosolization and dissolution characteristics.
• These findings present a novel approach for instant drug formulation with promising pulmonary delivery applications.