Dhand Rajiv, Eicher Joachim, Hänsel Michaela, Jost Ingeborg, Meisenheimer Martin, Wachtel Herbert
Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN 37920, USA.
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein 55216, Germany,
Int J Chron Obstruct Pulmon Dis. 2019 Mar 5;14:509-523. doi: 10.2147/COPD.S190639. eCollection 2019.
The Respimat is a handheld, propellant-free, soft-mist inhaler. Observations by patients and physicians prompted development of an improved second-generation Respimat inhaler. Human-factor studies assessing the usability of the new inhaler and in vitro assessment of aerosol performance are important to demonstrate functionality of the updated inhaler.
Studies were performed to assess any possible impact of the reusable Respimat inhaler design on aerosol performance (delivered dose [DD] and fine-particle dose [FPD]) and iteratively assess and improve usability of the new design. The tiotropium-olodaterol inhalation solution for Respimat was used as a model. The DD and FPD of the reusable Respimat inhaler (across multiple cartridges) and the disposable Respimat inhaler were determined by laser diffraction and with an alternative Andersen cascade impactor. Usability was measured across three studies involving health care professionals and patients with diagnoses of COPD, asthma, or combined disease (with and without experience with the Respimat inhaler). These studies measured performance of handling tasks and collected subjective feedback directly related to the inhaler's new or altered features, which fed into optimization of the inhaler.
DDs of tiotropium and olodaterol were stable up to 15 cartridges and consistently within the upper and lower limits of the disposable Respimat inhaler. The FPD was also found to be batch-consistent over the cartridges and comparable with the reference. The usability of the reusable Respimat inhaler compared with the disposable inhaler was improved in terms of assembly and daily use. Cartridge exchange was rated as intuitive and easy to very easy.
The new reusable Respimat is a medical inhaler developed with enhanced features that meets health care professionals' and patients' needs. Drug delivery across multiple cartridges is not affected by the design. Compared with the original disposable inhaler, the usability of the reusable inhaler has been improved, and cartridge exchange was rated as easy to perform. The reusable Respimat provides greater convenience for patients vs the disposable inhaler, with reduced environmental impact.
Respimat是一种手持式、无推进剂的软雾吸入器。患者和医生的观察促使开发出改进的第二代Respimat吸入器。评估新吸入器可用性的人因学研究以及气雾剂性能的体外评估对于证明更新后吸入器的功能很重要。
进行了多项研究，以评估可重复使用的Respimat吸入器设计对气雾剂性能（递送剂量[DD]和细颗粒剂量[FPD]）的任何可能影响，并反复评估和改进新设计的可用性。使用用于Respimat的噻托溴铵-奥达特罗吸入溶液作为模型。通过激光衍射和另一种安德森级联撞击器测定可重复使用的Respimat吸入器（多个药筒）和一次性Respimat吸入器的DD和FPD。在三项涉及医疗保健专业人员以及诊断为慢性阻塞性肺疾病（COPD）、哮喘或合并疾病的患者（有无使用Respimat吸入器经验）的研究中测量了可用性。这些研究测量了操作任务的性能，并收集了与吸入器新的或改变的特征直接相关的主观反馈，这些反馈用于吸入器的优化。
噻托溴铵和奥达特罗的DD在多达15个药筒时保持稳定，并且始终在一次性Respimat吸入器的上下限范围内。还发现FPD在各个药筒之间批次一致，并且与参考值相当。与一次性吸入器相比，可重复使用的Respimat吸入器在组装和日常使用方面的可用性得到了改善。药筒更换被评为直观且非常容易。
新型可重复使用的Respimat是一款功能增强的医用吸入器，满足了医疗保健专业人员和患者的需求。跨多个药筒的药物递送不受设计影响。与原来的一次性吸入器相比，可重复使用吸入器的可用性得到了改善，并且药筒更换被评为易于操作。与一次性吸入器相比，可重复使用的Respimat为患者提供了更大的便利，同时减少了对环境的影响。
