Mass Median Plume Angle: A novel approach to characterize plume geometry in solution based pMDIs.

High-speed laser imaging (HSLI) is the preferred technique to characterize the geometry of the plume in pressurized metered dose inhalers (pMDIs). However, current methods do not allow for simulation of inhalation airflow and do not use drug mass quantification to determine plume angles. To address these limitations, a Plume Induction Port Evaluator (PIPE) was designed to characterize the plume geometry based on mass deposition patterns. The method is easily adaptable to current pMDI characterization methodologies, uses similar calculations methods, and can be used under airflow. The effect of airflow and formulation on the plume geometry were evaluated using PIPE and HSLI. Deposition patterns in PIPE were highly reproducible and log-normal distributed. Mass Median Plume Angle (MMPA) was a new characterization parameter to describe the effective angle of the droplets deposited in the induction port. Plume angles determined by mass showed a significant decrease in size as ethanol increases which correlates to the decrease on vapor pressure in the formulation. Additionally, airflow significantly decreased the angle of the plumes when cascade impactor was operated under flow. PIPE is an alternative to laser-based characterization methods to evaluate the plume angle of pMDIs based on reliable drug quantification while simulating patient inhalation.