Novartis Pharmaceutical Corporation, East Hanover, NJ 07936-1080, USA.
Curr Med Res Opin. 2010 Nov;26(11):2527-33. doi: 10.1185/03007995.2010.518916. Epub 2010 Sep 15.
To report performance characteristics and robustness of the Breezhaler device, a new capsule based dry powder inhaler (DPI) with low resistance (0.07 cm H(2)O(½)/L/min) facilitating high inspiratory flow rates. This device was developed to deliver the novel, inhaled once-daily ultra long-acting β(2)-agonist indacaterol, formulated as an inhalation powder in a capsule, and other investigational drugs including NVA237 and QVA149.
Peak inspiratory flow rates via the DPI device were determined in patients with chronic obstructive pulmonary disease (COPD) using an Inhalation Profile Recorder. The flow-rate dependency of the in vitro performance (delivered dose and fine particle mass) of indacaterol in the DPI device was examined. Data on patient experience were captured throughout the indacaterol phase III registration program, and the robustness of the device was investigated after mechanical stress.
Twenty-six patients with COPD that ranged from mild to very severe were recruited (aged 49-84 years); 25 patients were able to generate flow rates in excess of 60 L/min via the DPI device. The mean delivered dose of indacaterol (150 and 300 µg) remained within 15% of the target dose, with a consistent fine particle mass at flow rates of 50-100 L/min. In the indacaterol registration program, patients with mild to very severe COPD were able to use the device successfully, with a low device complaint rate (<0.03%) and no device failures from approximately 90,000 devices. In mechanical stress tests, drop testing resulted in, at most, only cosmetic damage, with no effect on the delivered dose.
The capsule based DPI device is a low resistance device, suitable for use by patients with a wide range of COPD severities, delivering a consistent dose irrespective of disease severity and age. The device provided consistent delivery of indacaterol with no reported device failures in clinical trials.
报告新型胶囊型干粉吸入器（DPI）Breezhaler 的性能特点和稳健性，该装置阻力低（0.07 cmH2O（½）/L/min），可实现高吸气流速。该装置旨在输送新型每日一次吸入长效β2-激动剂茚达特罗，以胶囊形式制成吸入干粉，并输送其他研究药物，包括 NVA237 和 QVA149。
使用 Inhalation Profile Recorder 测定慢性阻塞性肺疾病（COPD）患者通过 DPI 装置的吸气峰流速。检查茚达特罗在 DPI 装置中的体外性能（递送至剂量和细颗粒质量）对流速的依赖性。在茚达特罗 III 期注册项目期间收集了患者体验数据，并在机械压力后研究了装置的稳健性。
共招募了 26 例轻至重度 COPD 患者（年龄 49-84 岁）；25 例患者能够通过 DPI 装置产生流速超过 60 L/min。150 和 300μg 茚达特罗的平均递送至剂量保持在目标剂量的 15%以内，在 50-100 L/min 的流速下，细颗粒质量一致。在茚达特罗注册项目中，轻至重度 COPD 患者能够成功使用该装置，装置投诉率低（<0.03%），大约 90,000 个装置中无装置故障。在机械压力测试中，跌落测试最多仅造成外观损坏，对递送至剂量无影响。
胶囊型 DPI 装置阻力低，适用于广泛的 COPD 严重程度患者使用，提供一致的剂量，与疾病严重程度和年龄无关。该装置在临床试验中提供了一致的茚达特罗输送，未报告装置故障。
