Trimethyl chitosan chloride (TMC) as a novel excipient for oral and nasal immunisation against diphtheria

TL;DRAbstract

Despite the obvious advantages of mucosal vaccination over invasive injections, degradation of the antigen in the gastro-intestinal tract and/ or low uptake by the mucosal associated lymphoid tissue (MALT) still complicate the introduction of efficient oral or nasal inactivated vaccines. In this study, trimethyl chitosan chloride (TMC) microparticles were prepared according to a precipitation/coacervation method and characterized with respect to morphology, size and antigen [diphtheria toxoid (DT)] loading and release. The stability of the DT-loaded microparticles was studied by determining possible alterations in these parameters over a period of three months. Then DT-specific systemic and mucosal humoral immune responses were measured in mice and rats after oral and nasal vaccination of DT combined with TMC microparticles and co-administered with TMC in solution. In these in vivo studies, the influence of the degree of substitution (DS) of TMC, the administration frequency and the an

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