A Novel Submicron Formulation of Nebulized Budesonide Significantly Decreases the Nebulization Time from a Variety of Commercially Available Jet Nebulizers

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RATIONALE: Nebulized ICS administration for the treatment of asthma is a popular treatment option for children and adults who lack the inspiratory capabilities and coordination to use metered-dose and dry powder inhalers. However, nebulization often involves lengthy treatment times that can lead to poor treatment compliance. Unit Dose Budesonide (UDB), a novel aqueous submicron budesonide formulation, has been developed to improve drug delivery and reduce delivery times compared to a marketed aqueous suspension (Pulmicort Respules; PR).

METHODS: Time to reach nebulizer sputter for four formulations (UDB 0.135 mg/1.5 mL, UDB 0.25 mg/1.5 mL, PR 0.250 mg/2.0 mL, PR 0.500 mg/2.0 mL) was determined using eight commonly used jet nebulizer & compressor combinations available in the US. Aerosol was sampled into the Next Generation Impactor at an operating flow rate of 15 LPM. Sputter was identified as the time when repeated episodes of significant crackling or hissing were noted within a 3 second interval, indicating drug output was deteriorating and coming to an end as the nebulizer approached its residual volume.

RESULTS: For all eight nebulizer/compressor combinations, UDB formulations nebulized significantly faster compared to each PR formulation (p < 0.001; paired t-test). UDB formulations reached nebulizer sputter in 1.3-3.7 minutes, 28-52% of the time it took both PR formulations to be delivered from the same nebulizer/compressor combination.

CONCLUSIONS: UDB is nebulized significantly faster than PR with a variety of jet nebulizers that are commonly purchased and used in the US. This may provide significant benefit during ICS administration to the uncooperative child, when lengthy treatment times may lead to poor compliance.