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.
Background and RationaleIndacaterol is an investigational, novel, inhaled once-daily long-acting β -agonist for the treatment of chronic obstructive pulmonary 2 disease (COPD). The therapeutic agent is administered as an inhalation dry powder using a new low resistance single dose dry powder inhaler (SDDPI) which will be known as Breezhaler® when approved in Europe. The aim of the present study was to investigate the in vitro dose delivery performance of indacaterol under a range of inspiratory flow rate conditions representing COPD patient use covering mild to very severe disease severity according to the GOLD guidelines.
MethodsThe characterization of the aerosol dose of indacaterol delivered to the lungs was performed using a combination of a standard in vitro Next Generation Impactor (NGI) coupled to a flow/volume simulator. The flow/volume simulator enabled simulation of representative patient inspiratory patterns by balancing and modulating the air flow through the inhalation device and auxiliary air to maintain a constant flow rate of 100 L/min through the NGI. Five replicate measurements were conducted for each patient inhalation profile. Six patient profiles (Figure 1) covering mild to very severe stages of COPD were selected from a previously conducted patient inspiratory flow rate study with 26 COPD patients, using the SDDPI device, (Pavkov R, Singh D, Reitveld I., Resp Drug Deliv 2008; 3: 683-686), covering a wide range of inhalation profile parameters (peak flow rate, flow acceleration, inhaled volume, inhalation time). Figure 1: Inhalation Profiles investigated in the study
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