Abstract:

Objective: As the conventional vaccines were accompanied by the limitations of pain, cold chain storage and sterility issues, a mucosal vaccine which is administered through pulmonary route was fabricated. A dry powder inhalation of tetanus toxoid (TT) and mannitol was prepared and evaluated for stability and immunogenicity in comparison to the conventional TT vaccine. Material and Method: TT and mannitol dry powder inhalation was prepared and evaluated for particle size analysis, scanning electron microscopy, FTIR, flow properties, TT content estimation, flocculation, and in vitro drug vaccine release studies. Immunological studies of the formulation were performed on BALB/c mice. Result and Discussion: The powder blend of tetanus toxoid and mannitol remained stable under the process conditions and after storage. The result was confirmed through a flocculation test. The FTIR analysis indictated no interactions between the components. The homogenization process yielded a powder with a geometrical particle size diameter of 1312 ± 1310.9 nm which was found suitable for pulmonary administration. The zeta potential and polydispersity index {PDI} were found to be -22.6 ± 0.16 mV and 0.499 ± 0.015, respectively. The diffusion studies indicated immediate release of the TT with 82.4 ± 6.7% of drug released within 2 h following the diffusion mechanism and zero order kinetics and it was found that mannitol didn’t retard the release of tetanus toxoid. Additionally, the flow properties of the dry powder inhalation were reported to have good flow properties. More importantly, the immunological studies inferred the induction of high systemic and mucosal immunity over conventional vaccines.

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