DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS

Taking into account the current Product specification file, the aim of the work was to develop the composition and technology for obtaining effervescent tablets based on solid dispersions of furazolidone in the form of an aqueous solution for external use.Materials and methods. The used substances w...

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Main Authors: A. O. Elagina, A. V. Belyatskaya, I. I. Krasnyuk (Jr.), I. I. Krasnyuk, O. I. Stepanova, T. V. Fateeva, E. A. Smolyarchuk, S. V. Kozin, O. N. Plakhotnaya, O. V. Rаstopchina, J. V. Rau
Format: Article
Language:Russian
Published: Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute 2022-03-01
Series:Фармация и фармакология (Пятигорск)
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Online Access:https://www.pharmpharm.ru/jour/article/view/1026
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author A. O. Elagina
A. V. Belyatskaya
I. I. Krasnyuk (Jr.)
I. I. Krasnyuk
O. I. Stepanova
T. V. Fateeva
E. A. Smolyarchuk
S. V. Kozin
O. N. Plakhotnaya
O. V. Rаstopchina
J. V. Rau
author_facet A. O. Elagina
A. V. Belyatskaya
I. I. Krasnyuk (Jr.)
I. I. Krasnyuk
O. I. Stepanova
T. V. Fateeva
E. A. Smolyarchuk
S. V. Kozin
O. N. Plakhotnaya
O. V. Rаstopchina
J. V. Rau
author_sort A. O. Elagina
collection DOAJ
description Taking into account the current Product specification file, the aim of the work was to develop the composition and technology for obtaining effervescent tablets based on solid dispersions of furazolidone in the form of an aqueous solution for external use.Materials and methods. The used substances were: furazolidone, anhydrous sodium carbonate (chemically pure), polyvinylpyrrolidone-24000±2000 (chemically pure), malic acid (analytically pure), tartaric acid (chemically pure), citric acid (chemically pure), sodium benzoate (chemically pure), ethyl alcohol 96% (chemically pure), purified water. Preparation of granulates is separate wet granulation in a fluidized bed (Mycrolab, BOSCH, Germany). Obtaining tablets is the process of pressing on a manual hydraulic test press (“PRG”, VNIR, Russia). The dependence of disintegration, abrasion capacity and crushing resistance on compacting pressure was investigated. Technological parameters of granulates, еру obtained effervescent tablets, shelf life and storage conditions were investigated according to the State Pharmacopoeia of the Russian Federation XIVth ed.Results. Two compositions of effervescent tablets containing solid dispersions of furazolidone as an active substance were obtained, which, when dissolved in 100 ml of water at room temperature (20°C), form a solution of furazolidone with a concentration of 0.004% in less than 5 minutes. The method of quantitative determination of the furazolidone content in the effervescent tablets was validated. A complex of physicochemical methods for the analysis of tablets was carried out. Quality standards have been developed. The developed compositions stability of instant tablets during storage during accelerated and long-term tests has been experimentally confirmed. The preliminary shelf life and storage conditions have been determined.Conclusion. The result of technological and chemical-pharmaceutical research is the creation and evaluation of the quality of a new instant furazolidone dosage form as effervescent tablet formulations.
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publishDate 2022-03-01
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spelling doaj-art-0d40a569fc5144b7a5bac2bf7d14e5bd2025-08-20T03:01:04ZrusVolgograd State Medical University, Pyatigorsk Medical and Pharmaceutical InstituteФармация и фармакология (Пятигорск)2307-92662413-22412022-03-01101556810.19163/2307-9266-2022-10-1-55-68423DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONSA. O. Elagina0A. V. Belyatskaya1I. I. Krasnyuk (Jr.)2I. I. Krasnyuk3O. I. Stepanova4T. V. Fateeva5E. A. Smolyarchuk6S. V. Kozin7O. N. Plakhotnaya8O. V. Rаstopchina9J. V. Rau10Sechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversityAll-Russian Research Institute of Medicinal and Aromatic PlantsSechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical UniversitySechenov First Moscow State Medical University; Istituto di Struttura della Materia, Consiglio Nazionale delle Ricerche (ISM-CNR)Taking into account the current Product specification file, the aim of the work was to develop the composition and technology for obtaining effervescent tablets based on solid dispersions of furazolidone in the form of an aqueous solution for external use.Materials and methods. The used substances were: furazolidone, anhydrous sodium carbonate (chemically pure), polyvinylpyrrolidone-24000±2000 (chemically pure), malic acid (analytically pure), tartaric acid (chemically pure), citric acid (chemically pure), sodium benzoate (chemically pure), ethyl alcohol 96% (chemically pure), purified water. Preparation of granulates is separate wet granulation in a fluidized bed (Mycrolab, BOSCH, Germany). Obtaining tablets is the process of pressing on a manual hydraulic test press (“PRG”, VNIR, Russia). The dependence of disintegration, abrasion capacity and crushing resistance on compacting pressure was investigated. Technological parameters of granulates, еру obtained effervescent tablets, shelf life and storage conditions were investigated according to the State Pharmacopoeia of the Russian Federation XIVth ed.Results. Two compositions of effervescent tablets containing solid dispersions of furazolidone as an active substance were obtained, which, when dissolved in 100 ml of water at room temperature (20°C), form a solution of furazolidone with a concentration of 0.004% in less than 5 minutes. The method of quantitative determination of the furazolidone content in the effervescent tablets was validated. A complex of physicochemical methods for the analysis of tablets was carried out. Quality standards have been developed. The developed compositions stability of instant tablets during storage during accelerated and long-term tests has been experimentally confirmed. The preliminary shelf life and storage conditions have been determined.Conclusion. The result of technological and chemical-pharmaceutical research is the creation and evaluation of the quality of a new instant furazolidone dosage form as effervescent tablet formulations.https://www.pharmpharm.ru/jour/article/view/1026furazolidoneeffervescent tabletsinstant tabletssolid dispersionssolubilitydissolution ratepolyvinylpyrrolidone
spellingShingle A. O. Elagina
A. V. Belyatskaya
I. I. Krasnyuk (Jr.)
I. I. Krasnyuk
O. I. Stepanova
T. V. Fateeva
E. A. Smolyarchuk
S. V. Kozin
O. N. Plakhotnaya
O. V. Rаstopchina
J. V. Rau
DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
Фармация и фармакология (Пятигорск)
furazolidone
effervescent tablets
instant tablets
solid dispersions
solubility
dissolution rate
polyvinylpyrrolidone
title DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
title_full DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
title_fullStr DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
title_full_unstemmed DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
title_short DEVELOPMENT OF NITROFURAN DERIVATIVE: COMPOSITION AND TECHNOLOGY OF EFFERVESCENT TABLETS WITH SOLID DISPERSIONS
title_sort development of nitrofuran derivative composition and technology of effervescent tablets with solid dispersions
topic furazolidone
effervescent tablets
instant tablets
solid dispersions
solubility
dissolution rate
polyvinylpyrrolidone
url https://www.pharmpharm.ru/jour/article/view/1026
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