Stability and functionality of the Immunoject single-dose, auto-reconstitution de

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DESCRIPTION (provided by applicant): Assuring the success of mass campaigns against bioterrorist or naturally occurring pathogens requires that vaccines, therapeutics, and other products are stored and ready for immediate use at the time the threat to public health is perceived. Storage is a major contributor to the cost of administration under these circumstances and a requirement to keep the active product refrigerated can increase the cost by a factor of three, or more. It is also generally accepted that single dose delivery systems provide additional benefits in terms of disease transmission and microbial contamination. These and other issues are resolved by Immunoject, a new platform device with application to the parenteral delivery of the many pharmaceutical products that may now be formulated as rapidly dissolving powders. The unit-dose auto-reconstitution device is compact, relatively flat, and presents an economically attractive storage profile. It consists of an integrally sealed aseptic film pouch with two compartments separated by a frangible membrane, together with an administration device made from molded plastic parts. One compartment of the pouch is sized to hold a pre-determined volume of water for injection while the other compartment houses a dose of pharmaceutical compound formulated as a rapidly dissolving and thermally stable powder. In four user-friendly steps, a healthcare worker applies thumb pressure to the water compartment which, in turn, causes the active powder to dissolve and then to be administered through a needle to the patient. The overarching goal of this project is to accelerate Immunoject on its path to commercialization by demonstrating that the device will maintain its functionality and the thermal stability of thimerosal-free hepatitis-B vaccine stored within its powder compartment. This will be achieved by achieving three specific aims. The first of these formulates the vaccine as rapidly dissolving nano- and micro-scale powders and completes assays to verify that the HBsAg antigen remains bonded to the alum adjuvant, and that the powders retain the vaccine's original potency. The second aim assures that the powders have adsorbed no statistically significant moisture in 48 hours and tests the functionality and performance of the Immunoject. And finally, the third aim assesses the stability of powders and filled Immunoject devices at temperatures from -20 ¿C through 65 ¿C with storage periods from one week through twelve months. PUBLIC HEALTH RELEVANCE: This project seeks to accelerate Immunoject, a new unit-dose, auto-reconstitution device for parenteral delivery, on its path to commercialization. The new device will significantly reduce the costs of storing and administering a prophylactic or therapeutic dose to subjects of a mass public health campaign provoked by the transmission of a bioterrorist or naturally occurring pathogen. Key to Immunoject's potential is the innovative formulation of active ingredients as thermally stable and rapidly dissolving dry powders.