Production of cromolyn sodium microparticles for aerosol delivery by supercritical assisted atomization

AAPS PharmSciTech
Ernesto ReverchonGiuseppe Caputo

Abstract

The purpose of this study was to produce cromolyn sodium (CS) micrometric particles with controlled particle size (PS) and PS distribution (PSD) suitable for aerosol delivery, using a supercritical fluids-based process. CS was micronized using the supercritical assisted atomization (SAA) technique at different solute concentrations in water and different precipitation temperatures. Two techniques were used to measure PS and PSD of produced particles: scanning electron microscopy image analysis and laser scattering analysis. The 2 techniques were compared to provide a complete description of the powder obtained. High-performance liquid chromatography analysis was used to verify the absence of degradation of CS after micronization; differential scanning calorimetry, thermogravimetric analysis (TGA), and X-ray analysis were performed to study the effect of operative conditions on the crystalline structure and on the water content of SAA micronized particles. The CS particles obtained were spherical, with a volumetric percentage of particles with a diameter ranging between 1 and 5 microm of 50% to 66%. The precipitation temperature had no significant effect on PSD, but high drying temperatures led to product degradation. Increasing...Continue Reading

References

Oct 1, 1971·Journal of Pharmaceutical Sciences·J S CoxW C McCrone
Nov 17, 1999·Journal of Pharmaceutical Sciences·L R ChenD J Grant
Apr 18, 2000·International Journal of Pharmaceutics·G A Stephenson, B A Diseroad
May 20, 2003·International Journal of Pharmaceutics·E Reverchon, G Della Porta
Jan 10, 2004·The Journal of Pharmacy and Pharmacology·E ReverchonA Spada
Oct 19, 2004·International Journal of Pharmaceutics·Abdolhossien Rouholamini NajafabadiMorteza Rafiee-Tehrani
Nov 5, 2004·The Journal of Pharmacy and Pharmacology·E ReverchonA Antonacci
Feb 16, 2006·Biotechnology and Bioengineering·E Reverchon, A Antonacci

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Citations

Jul 16, 2009·Biotechnology and Bioengineering·Renata AdamiErnesto Reverchon

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