Purpose

A new Circulaire II (holding chamber) was designed to be used with VixOne nebulizer to increase the inhalable doses reaching the patient. The aim of this study was to evaluate the efficacy of this holding chamber with VixOne nebulizer and determine its usability with other nebulizers.

Methods

The aerodynamic characteristics of emitted dose of 2 ml salbutamol solution, 5000 μg/ml, were evaluated using cooled Andersen cascade impactor at inhalation flow 15 L/min. The respirable solutions were nebulized using 3JN (VixOne, NebuTech, and En full Kit) with both holding chamber and T-piece. To evaluate the pulmonary and systemic bioavailability, 12 non-smoking health subjects (6 females), > 18 years, with an average(SD) FEV₁ > 90% of predicted, inhaled nebulized aerosol of 1 ml respirable solution (5000 μg salbutamol), diluted to 2 ml total volume using normal saline through the same nebulizer setting described above using normal tidal breathing. Subjects provided urine samples 30 min post-dosing (USAL0.5) as an index of pulmonary bioavailability and cumulatively collected their urine for 24 h (USAL24) as an index of systemic bioavailability. To determine the amount that would reach the patients (aerosol-emitted), subjects again inhaled 1 ml salbutamol-diluted respirable solution through the same nebulizer setting described above but with filters to capture salbutamol-emitted.

Results

Amount of salbutamol deposited in the holding chamber was significantly higher than in T-piece among all nebulizers (p < 0.001). The fine particle fraction (FPF), < 3 μm, of VixOne with holding chamber, was significantly higher (p < 0.001) and the mass median aerodynamic diameter (MMAD) was significantly lower (p = 0.022) than that with T-piece. The NebuTech and Kit had lower FPF and higher MMAD with holding chamber compared to T-piece (p < 0.05). There was no significant difference in the USAL24 and the emitted aerosol between the 3JNs with holding chamber or T-piece.

Conclusions

Holding chamber did not significantly increase the emitted aerosol or USAL24 responsible for the side effect but improved the FPF < 3 μm and MMAD, responsible for lung deposition, with VixOne-JN only. Holding chamber, or similar add-on device, can be used with other nebulizers other than the VixOne, not to increase the inhaled dose but as a fugitive aerosol saver.

中文翻译：

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容纳室作为附加装置对不同喷射雾化器的气雾输送和逃逸气雾的影响

目的

设计了一种新的Circulaire II（容纳室），与VixOne雾化器配合使用，以增加到达患者的可吸入剂量。这项研究的目的是评估装有VixOne雾化器的储藏室的功效，并确定其与其他雾化器的可用性。

方法

使用冷却的Andersen级联撞击器以15 L / min的吸入流量评估了2 ml沙丁胺醇溶液5000 mg / ml的发射剂量的空气动力学特性。可吸入溶液使用带有保持室和T型管的3JN（VixOne，NebuTech和En full Kit）雾化。为了评估肺和全身的生物利用度，年龄在18岁以上，平均（SD）FEV为_1的12名非吸烟健康受试者（6名女性） > 90％的预计吸入雾化气雾，包括1 ml可吸入溶液（5000μg沙丁胺醇），使用生理盐水通过上述相同的雾化器设置，使用正常潮气呼吸，将其稀释至总体积为2 ml。受试者在给药后30分钟提供尿液样本（USAL0.5）作为肺部生物利用度的指标，并在24小时内累积收集其尿液（USAL24）作为全身生物利用度的指标。为了确定到达患者的量（气雾剂排放），受试者再次通过与上述相同的雾化器设置吸入1毫升沙丁胺醇稀释的可吸入溶液，但要使用过滤器来捕获沙丁胺醇排放的物质。

结果

在所有雾化器中，沉积在储存室中的沙丁胺醇的量显着高于T型管中的沉积物（p  <0.001）。带有储藏室的VixOne的细小颗粒分数（FPF）<3μm显着更高（p  <0.001），质量平均空气动力学直径（MMAD）显着低于 T形件（p = 0.022）。与T形件相比，带有保持室的NebuTech和Kit的FPF较低，而MMAD较高（p  <0.05）。在带有保持室或T型件的3JN之间，USAL24和散发的气溶胶没有显着差异。

结论

仅使用VixOne-JN，储藏室并未显着增加引起副作用的散发气溶胶或USAL24，但改善了导致肺部沉积的FPF <3μm和MMAD。储藏室或类似的附加设备可与VixOne以外的其他雾化器一起使用，不是增加吸入剂量，而是作为逃逸的气雾剂。