Bauer Andrea, McGlynn Paul, Bovet Li Li, Mims Pamela L, Curry Lisa A, Hanrahan John P
Aerosol Development, Sepracor, 84 Waterford Drive, Marlborough, MA 01752, USA.
Respir Care. 2009 Oct;54(10):1342-7.
Arformoterol, the (R,R) isomer of formoterol, is approved as an inhalation solution for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. Multiple nebulizer systems are commercially available. Different nebulizers can differ significantly in drug output, which may impact drug delivery and clinical efficacy. This study compared the aerosol properties of arformoterol delivered via 5 commonly used nebulizer systems for the home-care market.
The delivered dose of arformoterol inhalation solution (15 microg/2 mL) was collected in a glass Dreschel-type apparatus. The delivered amount in fine-droplet fraction was assessed with an Andersen cascade impactor, and droplet size (average median diameter and average percent<5 microm) was evaluated via laser diffraction. Compressor flow rate measurements were taken after 1 min and 6 min by placing the flow meter in line with each system.
The Pari LC Plus, Updraft II Opti-Neb, and NebuTech systems delivered similar amounts of the 15-microg nominal dose (from 23% to 25%). The Pari LC Star and Sidestream systems delivered slightly higher doses (31% and 35%, respectively). The nebulizer/compressor systems differed somewhat with respect to droplet size. The NebuTech delivered the lowest fine-droplet fraction (61%) via Andersen cascade impactor, and the smallest percent of droplets<5 microm (40%) via laser diffraction. The Pari LC Star and Sidestream delivered the highest fine-droplet fraction (100% and 93%, respectively), and the greatest percent of droplets<5 microm (84% and 88%). The fine-droplet fractions for the Updraft II Opti-Neb and Pari LC Plus were 93% and 89%, respectively, and the percent of droplets<5 microm was about 67%. Compressor flow rates ranged from 3.2 L/min (Pari LC Plus) to 5.4 L/min (NebuTech).
The results of this study demonstrate that the choice of nebulizer/compressor system can influence the aerosol properties of arformoterol inhalation solution and should be considered when prescribing nebulized medications.
阿福特罗是福莫特罗的（R，R）异构体，已被批准作为吸入溶液用于治疗慢性阻塞性肺疾病患者的支气管收缩。市场上有多种雾化器系统可供选择。不同的雾化器在药物输出方面可能存在显著差异，这可能会影响药物递送和临床疗效。本研究比较了通过5种常用的家用雾化器系统递送的阿福特罗的气溶胶特性。
将阿福特罗吸入溶液（15μg/2mL）的递送剂量收集在玻璃德雷舍尔型装置中。用安德森级联撞击器评估细滴部分的递送量，并通过激光衍射评估液滴大小（平均中位直径和平均百分比<5μm）。在1分钟和6分钟后，将流量计与每个系统串联放置，测量压缩机流速。
帕里LC Plus、Updraft II Opti-Neb和NebuTech系统递送的15μg标称剂量的量相似（从23%到25%）。帕里LC Star和侧流系统递送的剂量略高（分别为31%和35%）。雾化器/压缩机系统在液滴大小方面有所不同。NebuTech通过安德森级联撞击器递送的细滴部分最低（61%），通过激光衍射递送的<5μm液滴百分比最小（40%）。帕里LC Star和侧流递送的细滴部分最高（分别为100%和93%），<5μm液滴的百分比最大（84%和88%）。Updraft II Opti-Neb和帕里LC Plus的细滴部分分别为93%和89%，<5μm液滴的百分比约为67%。压缩机流速范围为3.2L/min（帕里LC Plus）至5.4L/min（NebuTech）。
本研究结果表明，雾化器/压缩机系统的选择会影响阿福特罗吸入溶液的气溶胶特性，在开具雾化药物处方时应予以考虑。
