It has been estimated that 16% of new drugs will be delivered via the respiratory tract for the treatment of both respiratory and non-respiratory diseases. These agents include surfactant, antibiotics, mucokinetics, peptides, anticancer agents, and biologics. Whereas there are excellent nebulizers for the delivery of microgram quantities of many small molecules, efficient and effective aerosol delivery of many of the above agents presents new challenges for aerosol delivery systems. In Phase I, we demonstrated the proof of principal of the components of an aerosol delivery system which addresses the following needs; a) shorter treatment times, b) elimination or at least reduction of the use of excipients c) delivery of fine respirable aerosols without shear-stress-induced molecular degradation d) administration of sparcely soluble agents and e) delivery of surfactant. Using this bench model of SUPRAER we generated large aqueous aerosols which following evaporation and concentration were delivered as respirable concentrated dry power aerosols at a concentration of 5 mg/l. This Phase II we will optimize, construct and test an alpha prototype of SUPRAER(tm), which will deliver 2 to 10 times the dose of active agent per breath than current technologies. The resultant dry power aerosol, of 3 ?m aerodynamic diameter will be delivered at inspiratory flow rates of 20-30 l/min. The alpha prototype will be robust, functional, manufacturable, and have patient friendly features. SUPRAER will be used to generate aerosols of surfactant, tobramycin, insulin and mannitol. The performance and output aerosol characteristics will be compared with competitive marketed products with FDA approval. SUPRAER(tm) will decrease the time required for inhalation therapy as well as broaden the range of therapeutic agents that can be successfully administered via the respiratory tract. ? ? ?
