Kamin Wolfgang, Ehlich Hilke
Pediatric Pneumology and Allergology, Childrens Hospital, Mainz University, Mainz, Germany.
Treat Respir Med. 2006;5(6):503-8. doi: 10.2165/00151829-200605060-00013.
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.
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.
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.
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.
本体外研究的目的是确定在幼儿潮气呼吸模式下，通过不含氯氟烃的压力定量吸入器（pMDI）使用200μg布地奈德时，经不同储雾罐给药的递送剂量。
模拟幼儿和儿童的潮气呼吸。测试的储雾罐有Babyhaler（R）、AeroChamber（R）小号和中号；pMDI为Budiair（R）200μg。在已预充和未预充的储雾罐中，一次揿压和五次吸入后测量输出量。在五次模拟吸入中的每次吸入后评估累积输出量。使用高效液相色谱和紫外检测，通过级联冲击器在已预充的储雾罐中测定气雾剂特性，即输出物的粒度分布。
五次吸入后，已预充储雾罐的总输出量在37.9μg至40.9μg之间，储雾罐和呼吸模式之间差异不大。该总输出量的约58 - 79%通过第一次呼吸从AeroChamber（R）Plus吸入，约26%从Babyhaler（R）吸入。对于所有三种储雾罐，＜5μm的细颗粒占递送剂量的87%至92%。
使用Babyhaler（R）和AeroChamber（R）Plus储雾罐进行五次呼吸时，Budiair（R）200μg吸入器的标称剂量（200μg）降低至40μg或更低的递送剂量。使用Babyhaler（R）单次呼吸时，递送剂量可进一步降低至最低10μg。未来有必要进行临床研究，以决定“临床疗效”、安全性和精确剂量调整。
