Gaining an insight into the importance of each inhalation manoeuvre parameter using altered patients’ inhalation profiles

Abstract The aerodynamic particle size distribution (APSD) and dose emission characteristics of indacaterol Breezhaler have been measured using ex-vivo methodology and altering original COPD inhalation manoeuvre profiles to investigate the influence of inspiratory parameters namely, the peak inhalation flow (PIF), inhalation acceleration rate (ACIM) and inhaled volume (Vin) by keeping two parameters fixed and varying the other one. All inhalation parameters had an impact on the dose emission, dose emptying from the capsule/device in the order of PIF>Vin>ACIM. ACIM and Vin have almost an equal effect on the delivered dose (DD) and the fine particle dose (FPD) but the impact of the PIF was the most pronounced. PIF also had the greatest impact on the mass median aerodynamic diameter (MMAD). Producing an optimal inhalation manoeuvre combining the highest PIF, ACIM and Vin in one single inhalation would improve both the quantity and the quality of the aerosol. Making two separate inhalation from each prepared dose would also be useful. This ex-vivo methodology replaying altered COPD profiles with the breath simulator allows an insight on the importance of each inhalation manoeuvre parameter which would have not been possible using conventional in-vitro Pharmacopoeial methodology.