Optimizing the thermal stability of influenza vaccine for microneedle delivery

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Desai, Miraj Nishil
Henderson, Clifford L.
Agrawal, Pradeep K.
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The purpose of this study was to create a thermally stable formulation of influenza vaccine that can be delivered transdermally using a microneedle patch. By altering drying conditions, storage conditions, and formulation components, vaccine activity can be preserved at room temperature for several months in a dried state. Delivery via a soluble, biodegradable polymer microneedle patch is the method of choice in this study because it allows for self-administration of the drug, creates no sharps waste, is pain free, has high bioavailability, and shows potential for removing influenza vaccine from cold chain dependency. By optimizing the combination of stabilizing techniques previously studied, preliminary results have shown that excipient solutions made up of sucrose, trehalose, and arginine, to name a few, in an ammonium acetate buffer are able to preserve close to 100% of vaccine activity for at least six months at room temperature when patches are loaded with a full human dose. These results show much promise for the eventual removal of many vaccine and drug formulations from cold chain dependency.
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