Airway Institute in Sendai Co., Ltd., Sendai, Miyagi, Japan. tamura@airway−sendai.com
Allergol Int. 2012 Mar;61(1):149-54. doi: 10.2332/allergolint.11-OA-0332. Epub 2011 Dec 25.
Although investigations of the drug aerosols generated from inhaled corticosteroid (ICS) preparations and combined drug preparations provide basic information about inhalation therapy, many clinicians have one-sided data about the precision of drug aerosols from the manufacturer. The present study was conducted to analyze and compare the performances of dry powder inhaler (DPI) devices of ICS and combined drug preparations.
The particle size of individual aerosols was measured according to the time-of-flight principle in terms of their aerodynamic diameter by using the aerodynamic particle sizer spectrometer Model 3321. Percent aerosolization was measured using only stage #0 and backup filters of the Andersen non-viable sampler model AN-200.
The particle size distribution of aerosols generated from a Turbuhaler™ and Twisthaler™ showed a mono-modal distribution of less than 5 μm. In contrast, Diskus™ showed a polydisperse distribution, ranging from 0.5 to 20 μm. The percentages of DPI preparations converted into aerosols with a particle size less than 11 μm at a suction flow rate of 28.3 L/min were 5.7-6.2% for Diskus, 37.5-47.0% for Turbuhaler, and 19.8% for Twisthaler. At a suction flow rate of 60 L/min, the conversion percentages for DPI preparations into aerosols with a particle size less than 7.6 μm were 5.9-7.5%, 78.2-86.7%, and 43.5%, respectively.
Because in vitro differences in the aerosolization among different DPI devices containing ICS and combined drug preparations were observed, prescribers of these preparations should consider whether the patients will benefit more from the treatment of the central airways versus the peripheral airways.
虽然吸入性皮质类固醇（ICS）制剂和联合药物制剂产生的药物气溶胶的研究为吸入治疗提供了基本信息，但许多临床医生对制造商提供的药物气溶胶的精确性只有片面的数据。本研究旨在分析和比较 ICS 和联合药物制剂的干粉吸入器（DPI）装置的性能。
根据飞行时间原理，使用空气动力学粒径谱仪 Model 3321 按照空气动力学直径测量单个气溶胶的粒径。仅使用 Andersen 不可生存采样器模型 AN-200 的第 0 级和备份过滤器测量气溶胶化百分比。
Turbuhaler™ 和 Twisthaler™ 产生的气溶胶的粒径分布呈小于 5 μm 的单模态分布。相比之下，Diskus™ 呈现出多分散分布，范围从 0.5 到 20 μm。在 28.3 L/min 的吸气流量下，将 DPI 制剂转化为粒径小于 11 μm 的气溶胶的百分比为 Diskus 为 5.7-6.2%，Turbuhaler 为 37.5-47.0%，Twisthaler 为 19.8%。在 60 L/min 的吸气流量下，将 DPI 制剂转化为粒径小于 7.6 μm 的气溶胶的百分比分别为 5.9-7.5%、78.2-86.7%和 43.5%。
由于观察到不同含有 ICS 和联合药物制剂的 DPI 装置之间的气溶胶化存在体外差异，因此这些制剂的处方医生应考虑患者是否会从中央气道的治疗中获益更多，而不是从外周气道的治疗中获益更多。
