Levofloxacin dry powder inhaler for high dose delivery

Abstract

Mucous plugs in the respiratory system of cystic fibrosis patients are often infected, typically by Pseudomonas aeruginosa. Nebulized levofloxacin is effective against P. aeruginosa, but the administration and cleaning process is time-consuming. To address this limitation, dry powder inhalers are a potential alternative if a high required dose could be loaded. The objective of this study was to develop and characterize an excipient-free levofloxacin powder produced by a solvent-free spray drying method. The obtained particles were small, rounded and crystalline. Under pharmacopoeial impactor conditions, high emitted, fine particle and respirable fractions were achieved, even with high drug loadings. Variations in the impactor pump’s air flowrate did not significantly affect the aerodynamic performance. After 12 months’ storage critical attributes remained largely unchanged. The developed system allows for the same dose delivery as the marketed product for nebulization using only four capsules, highlighting its potential in cystic fibrosis treatments.