Authors: Kamin, Wolfgang¹; Ehlich, Hilke²

Source: Treatments in Respiratory Medicine, Volume 5, Number 6, 2006 , pp. 503-508(6)

Publisher: Adis International

Abstract:

Objectives: The aim of this In Vitro study was to determine the delivered dose of budesonide 200μg 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^®, AeroChamber^® Plus small and medium; the pMDI was Budiair^® 200µg. 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 37.9µg and 40.9µg with little differences between spacers and breathing patterns. About 58-79% of this total output was inhaled with the first breath from the AeroChamber^® Plus and about 26% from the Babyhaler^®. The fine particles <5μm ranged between 87% and 92% of the delivered dose for all three spacers.

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

Keywords: Budesonide; Budesonide; Children; Drug delivery systems

Document Type: Research article

Affiliations: 1: 1 Pediatric Pneumology and Allergology, Childrens Hospital, Mainz University, Mainz, Germany 2: 2 Inamed Research GmbH & Co. KG, Gauting, Germany

Publication date: 2006-01-01

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