Developing Human-Compatible Needleless Delivery Systems for Administering Bioscavengers

Phase II will focus on the design and development of a prototype needle-free injection system for administering BChE enzyme into humans to provide protection against chemical warfare agents. The Phase I proof-of-concept demonstrated the accelerateddelivery of BChE into the circulatory system using needle-free injection. The second phase of this project will consist of the following three tasks: 1) Develop and quantify a prototype needle-free injector. This task includes product, environmentaland human safety testing. A protector cap will be used to prevent pathogen transfer between patients; 2) Conduct trials on non-human primates to determine the percent of enzyme delivered, the peak level of enzyme activity and the duration of the enzymeat that level; 3) Determine the efficacy of this enzyme as a bioscavenger by exposing injected rodents to OP or pesticides; and 4) Deliver a prototype injector to the Army for chemical warfare studies. The overall goal of this project is to provide theArmy with a system to allow rapid injection of the enzyme into soldiers in the event of a chemical attach on the battlefield. In order to achieve this goal, the usability, safety and efficacy of the device will be proven. For the military, this devicewould allow rapid injection of troops prior to a potential chemical exposure. In this situation, troops should be injected 12 hours prior to possible exposure and re-injected weekly as long as the threat continues. Needle-free injection has been shown tobe faster, less painful, safer and more efficacious. In general, needle-free administration of vaccines, biologicals and antibiotics dramatically increase the speed of injection, improves drug absorption, reduces costs and eliminates the hazardsassociated with sharps and sharps disposal. Needle-free administration of drugs has wide application throughout the military and public health sectors.--------------------------------------- Needle & Syringe----------------- Needle-freeDelivery Speed ----------------- 120 injections / hour----------- 600 injections / hourCost per Injection-------------- .20 for disposable syringe----- $.08 for needle-freeDose Accuracy------------------- +-17% ------------------------- +-2%Disposal Method ---------------- Sharps Incineration ----------- Bio-hazard bag (No sharps)Volume (10,000 injections)------ 37.2 Cubic feet -------------- 6.4 Cubic feet Source: WHO Bulletin; 2002,80(11)