DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT

Objective of the study is to experimentally substantiate the possibility of production of anti-cholera immune-enterosorbent in the pharmaceutical form of a pill.Materials and methods: experimental antitoxic immune-enterosorbent against cholera, stabilized using cool dehumidification. Residual moistu...

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Main Authors: M. V. Ovchinnikova, A. V. Komissarov, E. G. Abramova, M. N. Kireev, A. Yu. Ul’yanov, D. N. Bibikov, M. N. Islyaeva, A. K. Nikiforov
Format: Article
Language:Russian
Published: Federal Government Health Institution, Russian Research Anti-Plague Institute “Microbe” 2017-09-01
Series:Проблемы особо опасных инфекций
Subjects:
Online Access:https://journal.microbe.ru/jour/article/view/421
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author M. V. Ovchinnikova
A. V. Komissarov
E. G. Abramova
M. N. Kireev
A. Yu. Ul’yanov
D. N. Bibikov
M. N. Islyaeva
A. K. Nikiforov
author_facet M. V. Ovchinnikova
A. V. Komissarov
E. G. Abramova
M. N. Kireev
A. Yu. Ul’yanov
D. N. Bibikov
M. N. Islyaeva
A. K. Nikiforov
author_sort M. V. Ovchinnikova
collection DOAJ
description Objective of the study is to experimentally substantiate the possibility of production of anti-cholera immune-enterosorbent in the pharmaceutical form of a pill.Materials and methods: experimental antitoxic immune-enterosorbent against cholera, stabilized using cool dehumidification. Residual moisture of enterosorbent lyophilizate was determined by means of Sartorius MA 150 moisture meter. Screen assay of the powders and granulates was performed applying the sieving of bulk material samples through screen set with sieve openings of various sizes. Specification of tap density was carried out with the help of SVM-10 unit. Granulation of specific enterosorbent was done using GPCG 2 LabSystem. The pills were manufactured in tablet press, MiniTabT. The hardness of the pallets was carried out by means of TBH 125 TD tester. The test for friability of the pills was performed in GTA 120.Results and conclusions. Utilization of cellulose microcrystalline and polyvinyl pyrolidone as pharmaceutical aids for granulation of lactose monohydrate is experimentally substantiated. It is established that the obtained granulate with passable values of technological parameters can serve as the basis for pharmaceutical dosage form of specific enterosorbent. Identified has been optimum mass of anti-cholera enterosorbent tablet cores. Demonstrated has been the possibility of Acryl-eze enteric coating application as protective shell of the pills. Studied has been specific activity of the pelleted enterosorbent in vitro, verified is its resistance capacity under conditions modeling gastrointestinal tract. In consequence of the performed trials and tests, technology for the production of antitoxic enterosorbent against cholera – enteric-coated tablet – has been developed. Long-term trials: the storage of the constructed preparation at 4–8°C within 24 months period (the observation time) – have revealed retention of enterosorbent activity, which testifies to its stability and defined the shelf life of specific tableted anti-cholera immune-enterosorbent.
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spelling doaj.art-9d847741ea014831a36fb0e3a2f886af2024-04-05T16:47:13ZrusFederal Government Health Institution, Russian Research Anti-Plague Institute “Microbe”Проблемы особо опасных инфекций0370-10692658-719X2017-09-010310010410.21055/0370-1069-2017-3-100-104421DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENTM. V. Ovchinnikova0A. V. Komissarov1E. G. Abramova2M. N. Kireev3A. Yu. Ul’yanov4D. N. Bibikov5M. N. Islyaeva6A. K. Nikiforov7Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Russian Research Anti-Plague Institute “Microbe”Objective of the study is to experimentally substantiate the possibility of production of anti-cholera immune-enterosorbent in the pharmaceutical form of a pill.Materials and methods: experimental antitoxic immune-enterosorbent against cholera, stabilized using cool dehumidification. Residual moisture of enterosorbent lyophilizate was determined by means of Sartorius MA 150 moisture meter. Screen assay of the powders and granulates was performed applying the sieving of bulk material samples through screen set with sieve openings of various sizes. Specification of tap density was carried out with the help of SVM-10 unit. Granulation of specific enterosorbent was done using GPCG 2 LabSystem. The pills were manufactured in tablet press, MiniTabT. The hardness of the pallets was carried out by means of TBH 125 TD tester. The test for friability of the pills was performed in GTA 120.Results and conclusions. Utilization of cellulose microcrystalline and polyvinyl pyrolidone as pharmaceutical aids for granulation of lactose monohydrate is experimentally substantiated. It is established that the obtained granulate with passable values of technological parameters can serve as the basis for pharmaceutical dosage form of specific enterosorbent. Identified has been optimum mass of anti-cholera enterosorbent tablet cores. Demonstrated has been the possibility of Acryl-eze enteric coating application as protective shell of the pills. Studied has been specific activity of the pelleted enterosorbent in vitro, verified is its resistance capacity under conditions modeling gastrointestinal tract. In consequence of the performed trials and tests, technology for the production of antitoxic enterosorbent against cholera – enteric-coated tablet – has been developed. Long-term trials: the storage of the constructed preparation at 4–8°C within 24 months period (the observation time) – have revealed retention of enterosorbent activity, which testifies to its stability and defined the shelf life of specific tableted anti-cholera immune-enterosorbent.https://journal.microbe.ru/jour/article/view/421anti-cholera immune-enterosorbentgranulationpelletizingapplication of protective coatingspecific activitystability
spellingShingle M. V. Ovchinnikova
A. V. Komissarov
E. G. Abramova
M. N. Kireev
A. Yu. Ul’yanov
D. N. Bibikov
M. N. Islyaeva
A. K. Nikiforov
DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
Проблемы особо опасных инфекций
anti-cholera immune-enterosorbent
granulation
pelletizing
application of protective coating
specific activity
stability
title DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
title_full DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
title_fullStr DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
title_full_unstemmed DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
title_short DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT
title_sort development of pharmaceutical dosage form of anti cholera immune enterosorbent
topic anti-cholera immune-enterosorbent
granulation
pelletizing
application of protective coating
specific activity
stability
url https://journal.microbe.ru/jour/article/view/421
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