title: Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Novartis Pharmaceutical Corporation, East Hanover, NJ 07936-1080, USA. richard.pavkov@novartis.com
authors.forename: Richard
authors.initials: R
authors.lastname: Pavkov
authors.forename: Stefan
authors.initials: S
authors.lastname: Mueller
authors.forename: Katrin
authors.initials: K
authors.lastname: Fiebich
authors.forename: Dilraj
authors.initials: D
authors.lastname: Singh
authors.forename: Frank
authors.initials: F
authors.lastname: Stowasser
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pignatelli
authors.forename: Benoît
authors.initials: B
authors.lastname: Walter
authors.forename: Dominik
authors.initials: D
authors.lastname: Ziegler
authors.forename: Mukul
authors.initials: M
authors.lastname: Dalvi
authors.forename: Juergen
authors.initials: J
authors.lastname: Dederichs
authors.forename: Ilse
authors.initials: I
authors.lastname: Rietveld
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000368:Aged; D000369:Aged, 80 and over; D058995:Dry Powder Inhalers / Q000295:instrumentation* / Q000592:standards*; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D010349:Patient Compliance; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy; D015363:Quinolones / Q000008:administration & dosage*; D012720:Severity of Illness Index
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D007189:Indans; D015363:Quinolones; C510790:indacaterol