The objective of the proposed effort is to develop a hand-held aerosol inhalation delivery system, based on ultrasonic atomization, to replace or augment current metered dose inhalers for both solutions and suspensions. Ultrasonic atomization produces low velocity, monodispersed droplets, which provide excellent lung deposition. The proposed device can deliver drugs for respiratory disease treatment, as well as systemic application that take advantage of the lung's ability to transfer molecules to the blood stream. Electronic control provides precise dose control meet or exceed FDA regulations. Moreover, the ultrasonic-based system does not require a propellant, which will help manufacturers eliminate chlorofluorocarbon-based system and will simplify formulation of their products. The feasibility of the system was demonstrated in Phase I by building and testing a benchtop unit. The Phase II aims are to optimize the Phase I unit by reducing its size and weight while increasing its efficiency. The optimized prototype's performance will determined with solution and suspension formulations in preparation for Phase III clinical trials. Measurements of drop size distributions, drug delivery dose-to-dose repeatability, and atomization rate as function of system parameters will be used to measure performance.
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