Scientific journal
Scientific Review. Technical science
ISSN 2500-0799
ПИ №ФС77-57440

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EXPERIMENTAL VALIDATION OF IMPLEMENTATION OF THE WATER-BASED FILM COATING FOR FINISHED DOSAGE FORM OF THE CHOLERA CHEMICAL VACCINE

Komissarov A.V. 1 Eremin S.A. 1 Zadokhin S.N. 1 Shulgina I.V. 1 Lobovikova O.A. 1 Vasin Y.G. 1 Klokova O.D. 1 Livanova L.F. 1 Nikiforov A.K. 1
1 Rospotrebnadzor Russian Research Anti-Plague Institute «Microbe»
Demonstrated is the possibility of implementation of the water-based film coating for the finished dosage form of the tableted cholera chemical bivalent vaccine. In the process of a full factorial experiment 24 specified are the optimum values of such technological parameters for tablet coating procedure as stored air pressure conveyed to the jet for spraying and automatization, water solution delivery rate, tablet-drying air flow and temperature, rotating speed of the drum. Tested have been vaccine quality characteristics. Established is the fact that they fully comply with the requirements stated in the pharmacopeial descriptions. Carried out is the comparative analysis of the finished dosage form properties with new coating in reference to earlier manufactured preparation batches. It is determined that application of the modified coating material provides for tablet hardening and elimination of friability, as well as improvements to its external view/appearance.