Interchangeability of Fluconazole Drugs
Fluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the reference and generic drugs’ equivalence with...
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| Format: | Article |
| Language: | Russian |
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Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-12-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/197 |
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| author | N. D. Bunyatyan B. B. Sysuev E. A. Sokova V. A. Evteev |
| author_facet | N. D. Bunyatyan B. B. Sysuev E. A. Sokova V. A. Evteev |
| author_sort | N. D. Bunyatyan |
| collection | DOAJ |
| description | Fluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the reference and generic drugs’ equivalence with the aim of assessing their interchangeability. Therefore, the aim of this study was to analyse fluconazole drug dosage forms and routes of administration, as well as qualitative and quantitative composition of active substances and excipients in order to identify characteristics that may affect interchangeability. The analysis of the nomenclature and composition of fluconazole drugs was carried out based on the data contained in the National Register of Medicinal Products of the Russian Federation and the Reference Book of Medicines®. It was shown that the current nomenclature of fluconazole drugs includes the following types of products: for parenteral use, internal use, and topical use. The generic fluconazole drugs in the form of capsules differ from the reference Diflucan® in excipients, shelf life, and packaging. The fluconazole substance has a number of specific features, i.e. the presence of polymorphic modifications, their specific characteristics, and the influence of the process parameters and storage on their stability. It was revealed that in many cases the production of fluconazole capsules involved the use of substances purchased from two or more suppliers, which may lead to changes in quality and bioavailability during storage. The obtained data can be used in the future for optimisation of pharmaceutical development and evaluation of interchangeability of fluconazole drugs. |
| format | Article |
| id | doaj-art-1abc82d1fbc24e3f9f74f305479f47bd |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-12-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-1abc82d1fbc24e3f9f74f305479f47bd2025-08-20T03:40:14ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-12-018424625110.30895/1991-2919-2018-8-4-246-251180Interchangeability of Fluconazole DrugsN. D. Bunyatyan0B. B. Sysuev1E. A. Sokova2V. A. Evteev3Sechenov First Moscow State Medical University Scientific Centre for Expert Evaluation of Medicinal ProductsSechenov First Moscow State Medical UniversitySechenov First Moscow State Medical University Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsFluconazole – an antifungal agent belonging to the chemical class of triazole derivatives – is represented in the Russian pharmaceutical market by a large number of generic drugs. An important issue of rational pharmacotherapy is the demonstration of the reference and generic drugs’ equivalence with the aim of assessing their interchangeability. Therefore, the aim of this study was to analyse fluconazole drug dosage forms and routes of administration, as well as qualitative and quantitative composition of active substances and excipients in order to identify characteristics that may affect interchangeability. The analysis of the nomenclature and composition of fluconazole drugs was carried out based on the data contained in the National Register of Medicinal Products of the Russian Federation and the Reference Book of Medicines®. It was shown that the current nomenclature of fluconazole drugs includes the following types of products: for parenteral use, internal use, and topical use. The generic fluconazole drugs in the form of capsules differ from the reference Diflucan® in excipients, shelf life, and packaging. The fluconazole substance has a number of specific features, i.e. the presence of polymorphic modifications, their specific characteristics, and the influence of the process parameters and storage on their stability. It was revealed that in many cases the production of fluconazole capsules involved the use of substances purchased from two or more suppliers, which may lead to changes in quality and bioavailability during storage. The obtained data can be used in the future for optimisation of pharmaceutical development and evaluation of interchangeability of fluconazole drugs.https://www.vedomostincesmp.ru/jour/article/view/197fluconazolegeneric drugsinterchangeabilityexcipientspharmaceutical equivalence |
| spellingShingle | N. D. Bunyatyan B. B. Sysuev E. A. Sokova V. A. Evteev Interchangeability of Fluconazole Drugs Регуляторные исследования и экспертиза лекарственных средств fluconazole generic drugs interchangeability excipients pharmaceutical equivalence |
| title | Interchangeability of Fluconazole Drugs |
| title_full | Interchangeability of Fluconazole Drugs |
| title_fullStr | Interchangeability of Fluconazole Drugs |
| title_full_unstemmed | Interchangeability of Fluconazole Drugs |
| title_short | Interchangeability of Fluconazole Drugs |
| title_sort | interchangeability of fluconazole drugs |
| topic | fluconazole generic drugs interchangeability excipients pharmaceutical equivalence |
| url | https://www.vedomostincesmp.ru/jour/article/view/197 |
| work_keys_str_mv | AT ndbunyatyan interchangeabilityoffluconazoledrugs AT bbsysuev interchangeabilityoffluconazoledrugs AT easokova interchangeabilityoffluconazoledrugs AT vaevteev interchangeabilityoffluconazoledrugs |