An In Vitro Method for Determining Regional Dosages Delivered by Jet Nebulizers

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Abstract
A methodology for determining the regional dosages delivered to the respiratory tract by a jet nebulizer is presented and applied to the DeVilbiss PulmoNeb® disposable nebulizer delivering a 2.5 ml nebule of Ventolin® (1 mg/ml salbutamol sulphate). Results are obtained both with tapping of the nebulizer, which enhances nebulizer performance, and without tapping. The nebulizer output is characterised by measuring the total mass and the mass of solids leaving the nebulizer per minute, and performing a control volume analysis of the nebulizer. Particle size distributions are determined by phased Doppler anemometry. Deposition probabilities are calculated using a semi-empirical model for the deposition of hygroscopic aerosol particles in healthy adult Caucasian males. Deposition probabilities are then converted to regional dosages using the measured nebulizer output characteristics. The regional dosages (% of initial dose in nebulizer) of Ventolin® delivered to the extrathoracic, bronchial, and alveolar regions of the respiratory tract are 0.248±0.005 mg (9.9%), 0.034±0.001 mg (1.4%), and 0.071±0.002 mg (2.8%) respectively when the nebulizer was tapped during operation, and 0.184±0.0O5 mg (7.4%), 0.025±0.001 mg (1.0%), and 0.052±0.002 mg (2.1%) when tapping was not used. This methodology provides a well controlled and rapid means of comparing the effectiveness of different nebulizers for use in aerosol therapy.