Mission-Ready Formulation and Needle-Free Delivery System for Protection Against Organophosphorous Chemical Warfare Agents

It is critical that the U.S. Army is mission ready and able to administer a pretreatment dose of butyrlycholinesterase (BChE) to protect warfighters and first responders from organophosphorous chemical warfare agents. Although intravenous (i.v.) andintramusculary (i.m.) means are available, they are not practical for delivery of large doses of purified human (BChE) that are required to protect against nerve agent exposure. The Army has a need to develop a needle-free system for delivering thesebioscavengers. Present needle-free systems are not available for delivering large quantities of BChE. Foster-Miller proposes a two-prong approach that is practical for first responders in battlefield situations. First, BChE will be reformulated toreduce the volume from ~10 mL to ~2 mL. Secondly, the pharmacokinetic activity of BChE in rodents will be evaluated using a needle free delivery system capable of handling the smaller volume.Foster-Miller has personnel with extensive experience in both drug formulation as well as medical device development. A needle-free device company has expressed strong interest in working with Foster-Miller to develop a new delivery system, while an FDAsupplier of nerve agent antidotes to the Department of Defense has expressed a strong interest in producing the new BChE formulation. (P-020557) Developing a practical needle-free method of administering protein-based prophylactics and therapeutic drugs in general would have significant commercial potential. Some specific commercial applications are protecting people from pesticide poisoning,reducing the risk of complications due to cocaine abuse, reversing muscle relaxant-induced apnea following surgery anesthesia, and alleviating symptoms caused by local anesthetics.