福罗地尔P和福莫特罗比率药单剂量胶囊吸入器两种给药装置的体外比较。

Carl P Criée, Thomas Meyer, Wolfgang Petro, Knut Sommerer, Peter Zeising
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引用次数: 14

摘要

福莫特罗是一种长效β(2)受体激动剂,具有快速支气管扩张的作用,可用于各种给药装置。然而,不同装置产生的药物颗粒大小和均匀性的差异可能导致不同的临床效果。本研究采用8级Andersen级联冲击器,在60 L/min的流量下,比较了Foradil雾化器(Foradil P)和非专利单剂量胶囊吸入器(ratiopharm)给药福莫特罗的体外空气动力学粒径分布、发射剂量和装置阻力。相对于福莫特罗胶囊吸入器,Foradil雾化器产生的颗粒具有较小的质量中值气动直径(3.5 vs 4.1微米,p = 0.018)和较小的测量颗粒直径分布(几何标准偏差2.2 vs. 2.5, p = 0.048)。Foradil雾化雾化器产生的细颗粒剂量比单剂量胶囊吸入器高44% (2.6 vs 1.8 μ g, p = 0.0001)。虽然单剂量胶囊吸入器产生的总放射剂量高于Foradil雾化器(11.2比10.0微克,p = 0.155,无统计学意义),但Foradil雾化器的可吸入部分高58%(25.7比16.3%,p = 2 × 10(8))。这两种装置都具有类似的低气流阻力。这些相对颗粒大小的分布表明,雾化器可以在临床上更有效地以高吸气流量将福莫特罗输送到肺部,这通常是使用该装置实现的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
In vitro comparison of two delivery devices for administering formoterol: Foradil P and formoterol ratiopharm single-dose capsule inhaler.

Formoterol, a long-acting beta (2)-agonist with a rapid onset of bronchodilation, is available in various delivery devices. However, differences in the size and uniformity of drug particles generated by different devices may result in variable clinical effects. The present study compared in vitro the aerodynamic particle size distribution, emitted dose and device resistance of formoterol delivered via Foradil Aerolizer (Foradil P) with those a non-proprietary single-dose capsule inhaler (ratiopharm), using an 8-stage Andersen Cascade Impactor set at a flow of 60 L/min. Relative to the formoterol ratiopharm capsule inhaler, Foradil Aerolizer produced particles with a smaller mass median aerodynamic diameter (3.5 vs. 4.1 microm, p = 0.018) and a smaller measured particle diameter distribution (geometric standard deviation 2.2 vs. 2.5, p = 0.048). The Foradil Aerolizer produced a 44% higher fine particle dose than the single-dose capsule inhaler (2.6 vs. 1.8 microg, p = 0.0001). Although the single-dose capsule inhaler produced a higher total emitted dose than that from Foradil Aerolizer (11.2 vs. 10.0 microg, p = 0.155, not significant), the respirable fraction from Foradil Aerolizer was 58% higher (25.7 vs. 16.3%, p = 2 x 10(8)). Both devices had a similarly low airflow resistance. These relative particle size profiles suggest that the Aerolizer may provide a more clinically effective delivery of formoterol to the lungs at the high inspiratory flows such as are typically achieved using this device.

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