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Immediate Release Formulation of Inhaled Beclomethasone Dipropionate-Hydroxypropyl-Beta-Cyclodextrin Composite
Hsien-Tsung Wu1, Yao-Hsiang Chuang1, Han-Cyuan Lin1
1Department of Chemical Engineering, Ming Chi University of Technology, 84 Gungjuan Rd., Taishan Dist., New Taipei City 24301, Taiwan.
Polymers
|May 28, 2022
Summary
Hydroxypropyl-β-cyclodextrin (HP-β-CD) and ethanol enhance beclomethasone dipropionate (BDP) solubility. Supercritical assisted atomization produced BDP-HP-β-CD composite particles with improved aerosolization and dissolution for pulmonary delivery.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Beclomethasone dipropionate (BDP) is a poorly soluble drug.
- Enhanced solubility is crucial for effective pulmonary drug delivery.
- Cyclodextrins are known to improve the solubility of hydrophobic drugs.
Purpose of the Study:
- To investigate the enhanced solubilization of beclomethasone dipropionate (BDP) using hydroxypropyl-β-cyclodextrin (HP-β-CD) and ethanol.
- To produce BDP-HP-β-CD composite particles with improved aerosolization and dissolution properties.
- To evaluate the potential of these composite particles for immediate-release pulmonary formulations.
Main Methods:
- Phase solubility method was used to determine drug solubility.
- Supercritical assisted atomization (SAA) with CO2 was employed for particle production.
- Aqueous ethanol (54.2% w/w) and leucine were used as solvent and dispersion enhancer.
- In vitro aerosolization and dissolution studies were performed on the composite particles.
Main Results:
- Solubility of BDP increased with HP-β-CD and ethanol concentrations.
- SAA successfully produced BDP-HP-β-CD composite particles.
- Fine particle fraction (FPF) of composite particles increased with the HP-β-CD to BDP mass ratio (Z).
- HP-β-CD enhanced the dissolution rate of BDP from the composite particles.
Conclusions:
- BDP-HP-β-CD composite particles demonstrate enhanced solubility, aerosolization, and dissolution.
- SAA is a viable technique for producing these composite particles.
- The developed BDP-HP-β-CD composite particles are suitable for immediate-release pulmonary drug formulations.
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