Data indicated that the Eudragit matrix protected BCG against simulated gastric fluid (SGF). Substantial losses in viability occurred at the initial formulation stage and at the stage of powder compaction.
Production of the dried powders resulted in a reduction in BCG viability. Samples were frozen at −20 ☌, freeze-dried and the lyophilised powders were compressed to produce BCG–Eudragit matrices. Since BCG is susceptible to inactivation in the gut, vaccine formulations were prepared from suspensions of Eudragit L100 copolymer powder and BCG in phosphate-buffered saline (PBS), containing Tween® 80, with and without the addition of mannitol or trehalose. It is most commonly administered parenterally, but oral delivery is highly advantageous for the immunisation of cattle and wildlife hosts of TB in particular. Bacillus Calmette–Guérin (BCG) vaccine is the only licensed vaccine against tuberculosis (TB) in humans and animals.
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