AKTIVAX, INC. — Department of Defense SBIR Phase I: A prefilled auto-injector device for storing a beneficial agent in a dry and stable forma

Description

A prefilled auto-injector device for storing a beneficial agent in a dry and stable format alongside a diluent, and automatically delivering the beneficial agent to a patient after reconstitution. The device comprises an automatic needle insertion mechanism and automatic needle retraction mechanism and is safe and disabled after use. The primary drug container of the auto-injector is made from high barrier foil material providing absolute barrier to moisture, oxygen and light. During shelf-life the drug is exposed to a single and safe contact material avoiding interaction with glass, silicone and rubbers that can have adverse drug stability effects. Injection is accomplished by applying external gas pressure to the foil package causing it to collapse and deliver the beneficial agent. A proprietary filling method allows filling pre-made sterile and sealed packages substantially reducing fill-finish operations and costs, and minimizing the cleanroom footprint required for manufacturing. The device is highly versatile and can be amended to a range of payloads in terms of drug volume and a number of constituents that need to be mixed; as well as the needle characteristics. The auto-injector is compact, low cost, and simple to operate.