Shchelkovo biocombinat in Russia producing over 1 billion vaccines annually for ruminants, swine, poultry, pets and horses has recently filed a patent application (RU2746141 – METHOD FOR PRODUCING A BRUCELLOSIS VACCINE FOR IMMUNIZATION OF VERTEBRATE ANIMALS) on a beta-cyclodextrin containing subcutaneous veterinary vaccine. The beta-cyclodextrin component is used as a stabilizer to preserve the immunogenicity against vertebrate brucellosis leading to a product of enhanced shelf life.
The optimized composition of the bulk vaccine is as follows: 10.0 kg of sucrose, 1.5 kg of edible gelatin, 2.0 kg of beta-cyclodextrin which is added to 85 kg of bacterial mass of the Brucella abortus RB-51 / AAA strain and 1.5 kg of distilled water.
Due to the presence of beta-cyclodextrin, the shelf life of the vaccine improves to two years compared to that of the CD-free control having insufficient stability. The increase of the efficacy of the vaccine prototypes was correlated to the amount of stabilizers (including beta cyclodextrin). The optimized composition after two-year storage still showed 80% efficacy, whereas the CD-free vaccine was only 30% efficient.
The opinion on parenteral use of cyclodextrins may vary amongst national authorities, however subcutaneous use of beta cyclodextrin derivatives is generally condidered safer than that of native beta cyclodextrin. Sulfobutylether beta cyclodextrin is present in some marketed verterinary drug compositions (Cerenia and Prevomax).
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