In Vitro Comparison of Output and Particle Size Distribution of Budesonide from Metered-Dose Inhaler with Three Spacer Devices during Pediatric Tidal Breathing.

Abstract

Objectives: The aim of this in vitro study was to determine the delivered dose of budesonide 200mug via a chlorofluorocarbon-free pressurized metered dose inhaler (pMDI) when administered through different spacers in tidal breathing patterns of young children.

Methods: Tidal breathing was simulated for toddlers and children. Spacers tested were Babyhaler((R)), AeroChamber((R)) Plus small and medium; the pMDI was Budiair((R)) 200microg. Output was measured after one actuation and five inhalations in primed and unprimed spacers. Cumulated output was evaluated after each of five simulated inhalations. Aerosol characteristics - i.e. particle size distribution of the output - were determined in primed spacers with a cascade impactor using high-performance liquid chromatography and UV detection.

Results: Total output from primed spacers after five inhalations was determined between 37.9microg and 40.9microg with little differences between spacers and breathing patterns. About 58-79% of this total output was inhaled with the first breath from the AeroChamber((R)) Plus and about 26% from the Babyhaler((R)). The fine particles <5mum ranged between 87% and 92% of the delivered dose for all three spacers.

Discussion and conclusion: The nominal dose (200microg) of the Budiair((R)) 200microg inhaler is reduced to 40microg delivered dose or less by using Babyhaler((R)) and AeroChamber((R)) Plus spacers taking five breaths. With a single breath the delivered dose can be reduced further to a minimum of 10microg using the Babyhaler((R)). Clinical studies are warranted in the future for decisions on 'clinical efficacy', safety, and exact dose adjustment.