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.
Highlights
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
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
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
Summary
В работе использовали лиофилизированную живую культуру Yersinia pestis вакцинного штамма EV линии НИИЭГ (сухую вакцину) ФСП 42-819806, а также вакцину чумную живую, таблетки для рассасывания. Вспомогательным сырьем (наполнитель вакцины) служили: крахмал картофельный (ГОСТ Р 5387610); глюкоза 424, ФСП 42-8198-06); ванилин (ГОСТ 16599-71); ментол 387); какао порошок (ГОСТ 108-76); кальция стеарат (ТУ 6-09-4233-76). Оценку микробиологической чистоты готовой формы вакцины и вспомогательного сырья проводили в соответствии с методами, изложенными в разделе «Микробиологическая чистота» (ОФС 42-0067-07) ГФ ХII издания [3], и согласно ФСП 42-8198-06 «Вакцина чумная живая, таблетки для рассасывания». Статистическую обработку результатов экспериментальных данных производили в соответствии с рекомендациями [6]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
