Dose Content Uniformity
Delivered Dose Testing Operation Photo

Photo of Delivered Dose Sampling Experiment for Inhalation Products

Delivered Dose is the total amount of active substance emitted from the mouthpiece of an inhaler when used in accordance with the manufacturer's instructions. Multi-dose inhalers must demonstrate consistency in the total amount of drug emitted per actuation throughout their total life cycle to ensure product safety and efficacy.

Applicable Products
 
Soft Mist Inhaler / SMI
 
Pressurized Metered-Dose Inhaler / pMDI
Delivered Dose Testing Schematic Diagram
 Test Principle Schematic
Note: The diagram above illustrates a typical setup for a dose uniformity sampling apparatus. Driven by a vacuum pump, the drug is drawn from the inhaler mouthpiece into the filter for collection, with a control valve regulating the sampling duration and flow rate.