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首页> 美国卫生研究院文献>AAPS PharmSciTech >The influence of formulation and spacer device on the in vitro performance of solution chlorofluorocarbon-free propellant-driven metered dose inhalers
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The influence of formulation and spacer device on the in vitro performance of solution chlorofluorocarbon-free propellant-driven metered dose inhalers

机译：配方和间隔装置对无氯氟烃推进剂驱动的定量吸入器溶液体外性能的影响

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The purpose of this study was to evaluate the hypothesis that spacer devices have limited effect on the in vitro fine particle dose emitted from solution metered dose inhalers containing different proportions of HFA134a [1,1,1,2-tetrafluoroethane] propellant. Two solution formulations (80% and 97.5% wt/wt HFA134a) were tested across the actuator alone, actuator plus Aerochamber, and Ace holding chamber. Particle size distributions were determined using laser diffraction (LD) and cascade impaction (CI). Multimodal particle size distributions were identified using LD. CI analyses were characterized by a major mode located at ≈0.5 μm. The fine particle dose emitted from the inhaler spacer combinations containing 97.5% HFA134a was independent of the device setup used. Fine particle doses were influenced by spacer setup in 80% HFA134a formulations, indicating different plume dynamics of low vapor pressure formulations. Sampling inlet deposition was approximately O when spacer devices were used with either formulation. When spacers were not used, sampling inlet deposition was increased significantly. However, inlet deposition with the 97.5% HFA134a formulation was significantly less than that of the 80% HFA134a formulation (≈25% of emitted dose compared with 69% respectively). Thus, high propellant concentration formulations appear to have more robust in vitro performance. This is particularly important given the preponderance of poor patient compliance that is associated with spacer use. High propellant concentrations had the advantage of fine particle doses that were independent of the device setup and significantly lowered sampling inlet deposition when no spacer was used.
机译：这项研究的目的是评估以下假设，即间隔装置对从含有不同比例的HFA134a [1,1,1,2-四氟乙烷]推进剂的溶液计量吸入器中释放的体外细颗粒剂量影响有限。单独在执行机构，执行机构加Aerochamber和Ace容纳腔之间测试了两种溶液配方（80％和97.5％wt / wt HFA134a）。使用激光衍射（LD）和级联碰撞（CI）确定粒度分布。使用LD鉴定多峰粒度分布。 CI分析的主要模式为≈0.5μm。从包含97.5％HFA134a的吸入器间隔器组合中释放出的细颗粒剂量与所使用的设备设置无关。细粒剂量受80％HFA134a配方中间隔物设置的影响，表明低蒸气压配方的羽流动力学不同。当隔离装置与任何一种配方一起使用时，采样入口的沉积量约为O。当不使用隔离物时，进样口沉积物会大大增加。但是，使用97.5％的HFA134a制剂的入口沉积显着小于80％的HFA134a制剂的沉积（约占发射剂量的25％，而分别为69％）。因此，高推进剂浓度的制剂似乎具有更强的体外性能。考虑到与垫片使用有关的患者依从性差，这尤其重要。高推进剂浓度的优点是细小颗粒剂量与设备设置无关，并且在不使用间隔物的情况下，显着降低了采样入口的沉积。

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