OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Lorraine Murphy; Stephen Rennard; James Donohue; Mathieu Molimard; Ronald Dahl; Kai-Michael Beeh; Juergen Dederichs; Hans-Jürgen Fülle; Mark Higgins; David Young Journal: Drugs Date: 2014-09 Impact factor: 9.546
Authors: Yongquan Li; Adam Bohr; Henrik Jensen; Jukka Rantanen; Claus Cornett; Moritz Beck-Broichsitter; Johan Peter Bøtker Journal: Pharm Res Date: 2020-01-21 Impact factor: 4.200
Authors: Mellissa Gomez; Joseph McCollum; Hui Wang; Mani Ordoubadi; Chester Jar; Nicholas B Carrigy; David Barona; Isobel Tetreau; Michelle Archer; Alana Gerhardt; Chris Press; Christopher B Fox; Ryan M Kramer; Reinhard Vehring Journal: Int J Pharm Date: 2020-12-02 Impact factor: 5.875