PURPOSE: The purpose of this study was to examine the aerosol characteristics of nebulized budesonide suspension utilizing two different impactor methodologies.
METHODS: Studies at two laboratories, NextBreath LLC (NB) and Respironics Respiratory Drug Delivery (UK) Ltd (RDD) utilized two different impactor types. A Next Generation Impactor (NGI) was used at NB and a Marple 298 Impactor at RDD to collect the budesonide suspension aerosol (250 μg/mL, 2 mL) generated with the SideStream Plus® (SS+; RDD) and the Pari LC+ (LC+; Pari Respiratory Systems) breath-enhanced nebulizers. Airflow through the impactors was 15L/min (NGI) and 2L/min (Marple). The analyses of budesonide were performed by HPLC.
RESULTS: There were no statistically significant differences in particle size (MMAD) and fine particle fraction (FPF) between the test methods - MMAD: [SS+: NGI=5.26μm versus Marple=5.52μm (p=0.27), and LC+: NGI=5.42μm versus Marple=5.85μm (p=0.07)], and FPF: [SS+: NGI=47.1% versus Marple=44.0% (p=0.29), and LC+: NGI=44.1% versus Marple=40.7%(p=0.06)]. An inter-nebulizer comparison per laboratory showed no statistically significant differences - MMAD: [NB: SS+ versus LC+ (p=0.36), and RDD: SS+ versus LC+ (p=0.24).], and FPF: [NB: SS+ versus LC+ (p=0.29), and RDD: SS+ versus LC+ (p=0.27)]. The nebulization times were, however, statistically significantly different showing SS+ to have the shorter nebulization times: [NB: SS+=142s versus LC+=176s (p=0.01), and RDD: SS+=154s and LC+=186s (p=0.015)].
CONCLUSION: The were no statistically significant differences in the aerosol characteristics (MMAD, FPF) of nebulized budesonide delivered with the SS+ and LC+ jet nebulizers and characterized with the NGI and Marple 298 impactors.
CLINICAL IMPLICATIONS: Jet nebulizer design has been shown to be critical for the successful delivery of the budesonide suspension. The present analysis indicates that MMAD values for the nebulized budesonide suspension may be expected to range between 5–6μm due to the insoluble budesonide particles, whereas the MMAD values for nebulized solutions generally are <5μm. The lack of difference in aerosol delivery between the SS+ and the LC+ nebulizers is of clinical importance as the results indicate that both nebulizers could be used to deliver budesonide suspension.
DISCLOSURE: Lauren Ziegler, No Product/Research Disclosure Information; Employee All authors are employees of the companies named in the affiliations.