A Miniature Autoinjector for Multicomponent Drugs and Vaccines

Chemical, biological, or toxin attacks in military and civilian settings are a serious and growing concern. Standard first aid for exposure to some chemical warfare agents and toxins includes the immediate administration of relevant antidotes using an autoinjector. When an attack occurs, pre-filled autoinjectors must be immediately available and thus highly portable, and they must be suitable for use by nonmedical personnel. Similarly, rapid distribution and administration of targeted vaccines is critical during biological attacks. Storage of drug formulations as separate components within the injector (e.g., a dry medication and a diluent) can significantly extend the shelf life of many medications. Creare proposes to develop a novel miniaturized autoinjector that automatically mixes two or more pre filled components immediately prior to injection. The drug storage and reconstitution method uses Creare"s recently patented technology for disposable, pre-filled drug cartridges and is applicable to single-component, dry/wet, liquid/liquid, and multicomponent combinations. In Phase I, we developed feasible autoinjector designs and demonstrated key autoinjector functions. In this Phase II project, we will optimize autoinjector platform designs, manufacture prototype devices, and test the prototypes to demonstrate functionality, reliability, and overall suitability for military and civilian use. We will also begin preparing for FDA product approval.