Orion Pharma, Orion Corporation, Espoo, Finland.
J Aerosol Med Pulm Drug Deliv. 2021 Jun;34(3):189-196. doi: 10.1089/jamp.2020.1592. Epub 2020 Sep 22.
Easyhaler (registered trademark by Orion Corporation) is a multidose dry powder inhaler (DPI) for the treatment of asthma and chronic obstructive pulmonary disease (COPD), designed to be simple and easy to use. Salmeterol-fluticasone propionate (S-F) Easyhaler (50/250 and 50/500 μg per dose), available in several European countries, provides combined inhaled corticosteroid and long-acting beta agonist therapy for the management of asthma and COPD. A requirement of the European Committee for Medical Products for Human Use guidelines is to demonstrate product performance under conditions that mimic real-life patient use. Therefore, our aims were to assess the robustness of the S-F Easyhaler by assessing the delivered dose (DD) and fine particle dose (FPD) throughout the inhaler lifespan and under simulated environmental stress conditions. This was a noncomparative exploratory study. Two batches and six to nine inhalers per batch from both dose strengths were used to assess drug delivery performance over the inhaler lifespan (doses 1-60). For determining the impact of simulated environmental stress (tests for exposure of dropping, vibration, moisture, and freeze-thawing) on DD and FPD, one batch and three inhalers per batch from both dose strengths were used per test, respectively. Aerodynamic particle size distribution was evaluated during the simulated dropping and vibration tests. DD and FPD from both dose strengths of S-F Easyhaler performance remained consistent through the inhaler lifespan and simulated environmental stress did not affect its performance. Similar DD and FPD values were observed with or without dropping, vibration, exposure to moisture, and freeze-thawing, and no inhaler breakages occurred during the simulated tests. The performance of S-F Easyhaler at both dose strengths suggests that reliable dosing and robustness can be achieved under real-life stress conditions; S-F Easyhaler is a durable DPI for the management of asthma and COPD.
易纳器（注册号：Orion 公司所有）是一种多剂量干粉吸入器（DPI），用于治疗哮喘和慢性阻塞性肺疾病（COPD），设计简单易用。沙美特罗氟替卡松丙酸酯（S-F）易纳器（剂量为 50/250 和 50/500μg），在几个欧洲国家有售，为哮喘和 COPD 管理提供了联合吸入皮质类固醇和长效β激动剂治疗。人用医疗产品欧洲委员会指南的要求是在模拟真实患者使用条件下证明产品性能。因此，我们的目的是通过评估整个吸入器寿命期间和模拟环境应激条件下的递送剂量（DD）和细颗粒剂量（FPD）来评估 S-F 易纳器的稳健性。这是一项非比较性探索性研究。使用来自两个剂量强度的两个批次和每个批次 6 至 9 个吸入器来评估吸入器寿命期间（剂量 1-60）的药物输送性能。为了确定模拟环境应激（跌落、振动、湿度和冻融试验）对 DD 和 FPD 的影响，每个批次和每个剂量强度的三个吸入器分别用于每个测试。在模拟跌落和振动试验期间评估空气动力学颗粒大小分布。来自两个剂量强度的 S-F 易纳器的 DD 和 FPD 性能在整个吸入器寿命期间保持一致，并且模拟环境应激不会影响其性能。在没有跌落、振动、暴露于湿度和冻融的情况下，观察到类似的 DD 和 FPD 值，并且在模拟测试中没有发生吸入器破裂。在两个剂量强度下，S-F 易纳器的性能表明，在现实生活中的应激条件下，可以实现可靠的给药和稳健性；S-F 易纳器是一种用于哮喘和 COPD 管理的耐用 DPI。
