Efficient Delivery to the Lungs of Flunisolide Aerosol From a New Portable Hand-Held Multidose Nebulizer

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Abstract
In order to provide asthmatic patients with an inhaler that does not use chlorofluorocarbon propellants, a novel multidose hand-held nebulizer (RESPIMAT, Boehringer Ingelheim Ltd.) has been developed. This device delivers 200 x 15 microL metered doses of drug solution, but does not use propellants of any kind. In this study of 10 healthy volunteers, the deposition pattern in the lungs and oropharynx of an ethanolic solution of flunisolide delivered via a prototype III multidose nebulizer has been determined by gamma scintigraphy. A comparison was made with the same dose (250 micrograms) of flunisolide delivered by a pressurized metered dose inhaler (MDI) and MDI plus Inhacort spacer. Mean (SD) whole lung deposition from the multidose nebulizer (39.7 (9.9) % of the metered dose) was significantly higher than that from either MDI (15.3 (5.1) %, P < 0.01) or MDI plus spacer (28.0 (7.0) %, P = 0.01). A mean 10.4% of the dose was recovered from an exhaled air filter for the multidose nebulizer, but less than 2% of the dose for MDI or MDI plus spacer. Oropharyngeal deposition was significantly reduced for the multidose nebulizer (39.9 (9.4) %) compared to MDI (66.9 (7.1) %), but was reduced further for the MDI plus spacer (27.3 (11.3) %). The multidose nebulizer delivers an unusually high percentage of an aerosol dose to the lungs, and it "targets" flunisolide to the lungs more effectively than the MDI. The multidose nebulizer could constitute a viable alternative to MDIs in asthma maintenance therapy.