Discussion on the Quality Control Test Method for a New Inhalation Drug Quantitative Assessment Instrument

Background Administration of drugs by inhalation is a common route for the treatment of chronic airway diseases. The ability of patients to use an inhaler device is a key factor in the effectiveness of treatment. Recently, a new type of quantitative assessment instrument for inhalation drugs has been developed in China, which can measure peak inspiratory flow (PIF) and inspiratory volume (VI) under conditions with various internal resistance of inhalers, thereby accurately assessing the ability of patients to use inhaler. However, there are no quality testing methods and adoption standards for this type of instrument at home and abroad. Objective To perform quality testing of the inhalation drug quantitative assessment instrument and evaluate its technical performance, in order to explore the application value of the method. Methods Various internal resistance of dry powder inhalers (DPI) was simulated by the inhalation drug quantitative assessment instrument (PF810) in 5 different gears (R1-R5 from low to hi