Strategies for Abatement of Contamination of Tableted Live Plague Vaccine at Different Stages of Manufacturing
https://doi.org/10.21055/0370-1069-2016-1-102-105
Abstract
Nowadays, problem of tableted drug form contamination with extraneous micro-flora is in the spotlight of scientists, as the specific share of these medical preparations in the world market amounts to more than 60 % and has a tendency to increase. Thus, objective of the study is to investigate the degree of contamination of the basic and auxiliary raw materials at different stages of live plague vaccine manufacturing, rapid dissolving tablets, and the ways to reduce it. Materials and methods. Utilized has been lyophilized Y. pestis live culture of the vaccine strain EV NIIEG, and the live plague vaccine, rapid dissolving tablets. Carried out has been assessment of “microbiological purity” at different stages of tableted live plague vaccine manufacturing: grinding, mixing, granulation, sublimation, and palletizing. Results and conclusions. Identified is the dynamic pattern of quantitative micro-flora composition of the mentioned above drug. Established is the alteration of microbial impurity at separate technological manufacturing steps. Specified is the technological stage with the most expressed contamination. Analysis of factors, which affect vaccine impurity, has revealed that finished dosage-form quality improvement is impossible without incoming control of stock and auxiliary materials, as well as enhancement of manufacturing procedure up to the level, complying with applicable pharmaceutical production standards. It is experimentally proved that series of tableted live plague vaccine, obtained using modernized technological equipment, provide for 3-fold reduction of contamination.
About the Authors
A. S. Tumanov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
V. V. Teterin
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
A. A. Leshchenko
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
A. V. Ezhov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
V. V. Biryukov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
S. V. Bagin
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
D. A. Mokhov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
S. V. Logvinov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
A. G. Lazykin
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
D. S. Beloborodov
Affiliated Branch of the 48th Central Research Institute of the Ministry of Defense
Russian Federation
Russian Federation
V. N. Bredikhin
Plague Control Center
Russian Federation
Russian Federation
I. V. Pozdnyakov
Plague Control Center
Russian Federation
Russian Federation
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Review
For citations:
Tumanov A.S., Teterin V.V., Leshchenko A.A., Ezhov A.V., Biryukov V.V., Bagin S.V., Mokhov D.A., Logvinov S.V., Lazykin A.G., Beloborodov D.S., Bredikhin V.N., Pozdnyakov I.V. Strategies for Abatement of Contamination of Tableted Live Plague Vaccine at Different Stages of Manufacturing. Problems of Particularly Dangerous Infections. 2016;(1):102-105. (In Russ.) https://doi.org/10.21055/0370-1069-2016-1-102-105
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