In addition, ongoing studies of GelVac formulations incorporating influenza antigens exhibited the potential for long-term stability during storage at room temperature.
The data showed the antigens were protected from activity loss during the dry powder formulation process, maintaining their potency. In addition, the GelSite polymer, the key ingredient of GelVac powder formulations, exhibited a distinct antigen stabilization effect in addition to conferring in situ gelling properties, both of which serve to increase the uptake of active antigens in the nasal cavity.
Equally important, the preservative-free dry powdered formulations incorporating influenza antigens were shown to be stable for over 18 months during storage at ambient room temperature. They were also highly immunogenic, eliciting robust immune responses in animals after nasal delivery.
GelSite polymer provides an in situ gelling property for optimal nasal delivery. Upon hydration by nasal fluid, the GelVac formulation changes from dry powder particles to wet gel particles, resulting in the formation of a gel that adheres to nasal mucus.