SBIR-STTR Award

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.

Keywords:
Prefilled, Reconstitution, Auto-Injector, Enhanced Drug Stability, Low-Cost, High-Efficiency Fill-Finish, Streamlined Use

AktiVax is developing ARAI, a versatile auto-injector platform that is robust, light-weight, intuitive and simple for self-administration of medical countermeasures. ARAI is designed with the Warfighter in mind for handling and operation single-handedly with compromised dexterity, while wearing protective gloves and gear . ARAI is a versatile platform that can be adapted to a range of payloads, in terms of product dose volume, number of product constituents that need to be safely stored and mixed just prior to injection, in a wet or dry format. In addition ARAI can accommodate a range of needle sizes and types.. In ARAI the beneficial injectable agent, or its constituents, are stored in a flexible package made from high barrier foil called ARCH – Aseptic Reconstitution Cartridge Hybrid. ARCH features improved product stability profile as the beneficial agent comes in contact with a single, safe material, avoiding glass, silicone lubricants, metals, rubbers, and adhesive that are present in conventional syringes and can adversely affect product stability. The foil material provides an absolute barrier to moisture, oxygen, and UV and is inherently drop-proof.

Keywords:
auto-injector, auto-reconstitution, self-administration, drug delivery,