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 accelerated delivery 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, environmental and 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 enzyme at 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 the Army 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.
Benefits: For the military, this device would 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 to be 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 hazards associated with sharps and sharps disposal. Needle-free administration of drugs has wide application throughout the military and public health sectors. --------------------------------------- Needle & Syringe----------------- Needle-free Delivery Speed ----------------- 120 injections / hour----------- 600 injections / hour Cost per Injection-------------- .20 for disposable syringe----- $.08 for needle-free Dose 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)
Keywords: Delivery System, Needle-free, Needleless, Injector, BChE, Chemical Warfare, Bioterrorism, Bioscavenger
