Of the 30 million US patients who suffer from respiratory disorders, over 4 million require frequent inhaled medication. Therapy sessions can last from several minutes to 3 hours. In addition, inhaled drugs are increasingly used to deliver drugs for systemic disorders. The utility of present devices is generally limited to those agents, which are effective in microgram quantities. There is a substantial unmet need for aerosol delivery systems for the rapid administration of therapeutic agents both in the hospital and at home. These include: surfactant, pentamidine, antibiotics, peptides, DNA and RNA viral vectors, antisense oligonuceotides, liposomes and novel anticancer agents. Many of these agents are sparsely soluble and susceptible to degradation.
The aim of this Phase I project is to demonstrate the feasibility of a novel aerosol generation and delivery system, SUPRAER(tm), which will deliver over 10 times the dose of active agent per breath than obtainable with current technology. The output aerosol will be a dry powder aerosol of 3 pm aerodynamic diameter entirely comprised of the active ingredient delivered at an inhalation flow rate of 20-30 I/min. In Phase II we will optimize the physical parameters, add user-friendly features, characterize its aerosol output and delivery as well as produce a manufacturable prototype. SUPRAER(tm) will decrease the time of inhalation therapy as well as broaden the range of therapeutic agents that can be successfully administered via the respiratory tract.
