Use of inspiratory profiles from patients with chronic obstructive pulmonary disease (COPD) to investigate drug delivery uniformity and aerodynamic dose emission of indacaterol from a capsule based dry powder inhaler

Most patients using dry powder inhalers (DPIs) are unable to achieve the inhalation parameters recommended for pharmacopoeial in-vitro dose emission testing. The dose emission characteristics of indacaterol Breezhaler (IB) have been measured using COPD patients' inhalation profiles (IPs) when using IB and replayed in-vitro using a breath simulator attached to an Andersen Cascade Impactor. The peak inhalation flow (PIF) of the profiles ranged from 28.3 to 87.8 L/min and inhaled volumes (Vin) from 0.7 to 3 L. The indacaterol total emitted doses (TED), fine particle dose (FPD) and mass median aerodynamic diameter (MMAD) were measured. TED varied between 61% to 83% of the 150 μg nominal dose, the FPD was found to vary between 19% and 30% and the MMAD from 3.7 μm to 2.3 μm with the increase of the profiles' PIF and Vin. The mean (SD) values were 113.4(8.9) μg, 39.7(5.0) μg and 2.7(0.5) μm, respectively. The quantity and the quality of the emitted dose from the indacaterol Breezhaler® are dependent on the capability of a patient generating an optimal inhalation profile. Therefore, when using the IB patients should be encouraged to inhale as fast as they can from the start of their inhalation and for as long as possible.