Lyophilization development feasibility study for heat-stable tablet formulation
An essential characteristic to ensure the affordability of the vaccine in low- and middle-income countries is to make it suitable for distribution without the need of cold chain.
Therefore, the suitable pH and salt concentrations as well as stabilizing excipients will be determined to generate a liquid formulation suitable for freeze-drying. In addition, the appropriate dose and concentration of buffer for a neutralization of stomach acid will be determined. The liquid formulation will be filled in preformed blisters sheets and freeze dried to generate lyophilized fast-dissolving tablets.