FORMULATION AND IN VITRO - IN VIVO EVALUATION OF TETANUS TOXOID-MANNITOL DRY POWDER INHALATION FOR PULMONARY DELIVERY

Abstract

Objective: A dry powder inhalation of tetanus toxoid and mannitol was prepared and evaluated for stability and its 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, FTIR, flow properties, encapsulation efficiency, 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. No interactions were reported according to FTIR analysis. 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 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. 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.