IN VITRO INVESTIGATION INTO FUGITIVE AEROSOL FROM A NOVEL 4TH GENERATION ADAPTIVE AEROSOL DELIVERY (AAD) SYSTEM

ABSTRACT

The recent Covid-19 pandemic has drawn attention to the amount of fugitive aerosol that is emitted by nebulizers. The novel I-neb Advance Adaptive Aerosol Delivery (AAD) System incorporates an improved AAD algorithm intended to reduce treatment times compared with earlier AAD devices. We conducted an in vitro test to determine the amount of fugitive aerosol that is emitted from the I-neb Advance (AAD) System. Three production equivalent investigational I-neb Advance nebulizers fitted with nonmetering chambers were filled with 1.7mL of 2mg/mL salbutamol solution. The delivered dose was collected on a filter during operation into a simulated breathing pattern (Tv=500mL, IE=11, f 15 bpm). A second filter was fixed 1 cm away from the exhalation port of the nebulizer with an extraction flow of 60 L/min. Each nebulizer was run in triplicate. Salbutamol on filters was quantitated by high performance liquid chromatography. The delivered doses had low co-efficients of variation, intra-nebulizer=0.83 to 3% and inter-nebulizer=0.77%. The fugitive aerosol was lower than the limit of quantification of the assay (0.18% of fill) in 2/3 of the tests. Measurable exhaled doses were all below 0.3% of the fill volume. The improved AAD algorithm used in the I-neb Advance (AAD) System delivered precise, reproducible doses with minimal fugitive aerosol emissions into a simulated breathing pattern. The minimization of fugitive aerosol emissions demonstrated by AAD nebulizers likely has an added relevance to aerosol treatment following the emergence of the Covid-19 pandemic. Key Message The novel I-neb Advance (AAD) System was shown to deliver reproducible doses of drug with minimal (<0.3% of the nominal dose) fugitive aerosol emissions. This observation could be important in clinical situations where there is a need to minimise escaping aerosol from nebuliser devices during use.