School of Applied Sciences, University of Huddersfield, Huddersfield, UK Almirall S.A., Barcelona, Spain.
Int J Clin Pract. 2012 Mar;66(3):309-17. doi: 10.1111/j.1742-1241.2011.02832.x.
This article reviews the Genuair(®) inhaler, a novel, multidose, breath-actuated dry powder inhaler. The inhaler design includes visual and acoustic feedback to reassure patients that they have taken their medication correctly, a dose indicator and a lock-out mechanism to prevent the use of an empty inhaler. The inhaler has medium airflow resistance and uses an optimised dispersion system to ensure effective deagglomeration of the inhalation powder. In vitro studies have demonstrated that the inhaler delivers a reproducible aerodynamic aerosol quality and is reliable under various thermal and mechanical stress conditions. Further studies in vitro have demonstrated that the total emitted dose and fine particle dose are both consistent over a range of inhalation flows from 45 to 95 l/min, as well as being independent of inhalation volume (2 l vs. 4 l) and storage conditions. In healthy subjects, delivery of aclidinium bromide 200 μg via the inhaler achieved high lung deposition (approximately 30% of the metered dose). A further study has shown that patients with moderate or severe chronic obstructive pulmonary disease can generate sufficient inspiratory airflow through the inhaler to reliably inhale the full dose and reset the inhaler. The inhaler has been used to deliver aclidinium in many clinical trials and the available data indicate that it has high acceptability amongst patients.
本文回顾了 Genuair（®）吸入器，一种新型、多剂量、呼吸驱动的干粉吸入器。该吸入器设计包括视觉和听觉反馈，以确保患者正确使用药物，还有剂量指示器和锁定机制，以防止使用空吸入器。该吸入器的气流阻力适中，并采用优化的分散系统，以确保吸入粉末的有效解聚。体外研究表明，该吸入器可提供可重复的空气动力学气溶胶质量，并且在各种热和机械应力条件下均可靠。进一步的体外研究表明，在 45 至 95 l/min 的各种吸入流速范围内，总发射剂量和细颗粒剂量均保持一致，并且与吸入量（2 l 与 4 l）和储存条件无关。在健康受试者中，通过该吸入器给予溴化阿地铵 200μg 可实现高肺部沉积（约为计量剂量的 30%）。另一项研究表明，中重度慢性阻塞性肺疾病患者可通过该吸入器产生足够的吸气气流，以可靠地吸入全剂量并重置吸入器。该吸入器已用于多项阿地铵的临床试验，现有数据表明，它在患者中具有较高的可接受性。
