METHODS: Device development and optimization was completed through Drug Product Characterization studies. The inspiratory flow rate required was evaluated among 3 batches each of BDP BAI 40 and 80 mcg. Air was drawn through the devices at flow rates from 12 L/min to 20 L/min, in 2 L/min increments. The inhaler was weighed before and after each test to determine actuation (60 mg weight difference confirmed actuation).
RESULTS: Main components of the BAI includes: mouthpiece cover, to maintain cleanliness when not in use and prepare the device for the next metered dose when opened; canister, contains the pressurized inhalation solution; primeless valve, allows for primeless metering for the delivery of metered doses and the Force Holding Unit, provides sufficient energy to actuate the canister during inhalation. Evaluation of the inspiratory flow rate required to actuate was conducted on ten inhalers in each of the 6 batches. Across the 40 mcg batches, 83.3% actuated at 16 L/min and all actuated at 18 and 20 L/min. Among the 80 mcg batches, 66.7% actuated at 18 L/min and all actuated at 20 L/min.
CONCLUSIONS: BDP BAI was designed for easier administration and is actuated with a minimum inspiratory flow rate of 20 L/min.