SBIR-STTR Award

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.

Thesaurus Terms:
aerosol, dosage, drug administration rate /duration, drug delivery system, inhalation drug administration, technology /technique development particle bioengineering /biomedical engineering

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 fm 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.

Thesaurus Terms:
aerosol, dosage, drug administration rate /duration, drug delivery system, inhalation drug administration, technology /technique development particle bioengineering /biomedical engineering