Effect of Aerosol Delivery System and Formulation on Nebulized Budesonide Output

Authors:
  • ABAriel Berlinski
    Ariel Berlinski
  • JWJ. Clifford Waldrep
    J. Clifford Waldrep
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Abstract
Inhaled glucocorticoids are the first line drug for the treatment of moderate to severe asthma. Nebulization is the inhalation method recommended for children below age 3. There are conflicting data in the literature regarding the clinical efficiency of nebulized Budesonide in children. We hypothesized that the delivery method and the formulation can dramatically affect the drug output and account in part for these conflicting results. In this study, we compared the aerosol output in the 0.4–5 μm particle size range, the nebulization efficiency, and the aerodynamic profile of aerosolized Budesonide. An ultrasonic nebulizer (UN) and 2 jet nebulizers (JN) (a conventional and an active venturi design, at different flow rates) were studied with liposomal and micronized formulations. All combinations of delivery methods and formulations except UN/liposomes had an aerodynamic profile adequate to deliver Budesonide to the lower airways. Liposomes showed a higher output than the micronized suspension (p < 0.01). The maximal output for both formulations was achieved by the active venturi JN operated at 8 lpm. For this delivery method, liposomes were 56.6% more efficient than the micronized formulation (p < 0.01). The highest output achieved with the micronized formulation was 17.3% of the initial dose placed in the nebulizer. UN had a very low output with both formulations. Our results suggest that the efficiency of the delivery method may account in part for the controversial clinical data available in the literature regarding the effectiveness of nebulized Budesonide for treating asthma in children. Liposomes constitute a suitable alternative for aerosolization of Budesonide with JN.

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