In Vitro Aerosol Measurements of the Novel Single Dose Reusable Dry Power Inhaler with Combination of Long-Acting Bronchodilator and Inhalated Corticosteroid

A novel dry powder inhaler, was developed to overcome the variability of inhaler performance on patient inspiratory effort when deaggregating the active medicament from lactose carrier during inhalation for the treatment of asthma. Herein the in vitro fine particle distribution of formoterol fumarate-budesonide combination delivered via newly developed dry powder inhaler was determined by Anderson Cascade Impactor at flow rates of 28.3 l/min, 54.8 l/min, and 90 l/min using a an aluminum idealized mouth-throat geometry (Alberta idealized throat model), Grgic et al.2004). Uniformity of delivered dose at 28.3 l/min using the USP-DUSA collecting tube was also generated. The percentage fine particle fractions (FPF) for formoterol fumarate and budesonide were (mean SD) 22.49 1.58 and 23.53 1.55 at 28.3 l/min and 25.72 4.72and 25.75 0.36 at 54.8 l/min respectively. As a percent of label claim, budesonide delivery distal to the mouth-throat was found to be 22.51.1 % at 28.3 l/min, 23.60.7 % at 60 l/min, and 28.6 0.6 % at 90 l/min, while for formoterol fumarate these values were 18.90.8 %, 19.40.8 % and 22.80.8 %. Flow rate differences between 28.3 l/min, 60 l/min and 90 l/min are not significant (pgreater than0.05). From these in vitro measurements, the developed dry powder inhaler demonstrated consistent fine particle fraction, low device retention, and consistent uniformity of delivered dose in range of 85.0 % to 115 % (SD 5 %).