| Journal: | Brazilian Journal of Pharmaceutical Sciences |
| Database: | PERIÓDICA |
| System number: | 000451968 |
| ISSN: | 1984-8250 |
| Authors: | Lazo, Raul Edison Luna1 Teleginski, Lilian Klein1 Maciel, Aline Biggi1 Silva, Marcos Antônio Segatto2 Mendes, Cassiana3 Bernardi, Larissa Sakis1 Murakami, Fábio Seigi4 Sonvico, Fabio5 Oliveira, Paulo Renato1 |
| Institutions: | 1Universidade Estadual do Centro-Oeste, Departamento de Farmacia, Guarapuava, Parana. Brasil 2Universidade Federal de Santa Catarina, Departamento de Ciencias Farmaceuticas, Florianopolis, Santa Catarina. Brasil 3Universidade Federal de Santa Catarina, Departamento de Quimica, Florianopolis, Santa Catarina. Brasil 4Universidade Federal do Parana, Departamento de Ciencias Farmaceuticas, Curitiba, Parana. Brasil 5Universita di Parma, Dipartimento per gli Alimenti e le Droghe, Parma, Emilia Romagna. Italia |
| Year: | 2022 |
| Volumen: | 58 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Analítico, descriptivo |
| English abstract | The aim of this work was to assess if the commercially available Fluconazole drug products (Reference, Generic and Similar) would meet the biowaiver criteria from Food and Drug Administration (FDA) and Brazilian Agency for Health Surveillance (ANVISA) agencies. All formulations were evaluated considering the dissolution profile carried out in Simulated Gastric Fluid (SGF) pH 1.2, Acetate Buffer (AB) pH 4.5 and Simulated Intestinal Fluid (SIF) pH 6.8. The results demonstrated that all formulations fulfilled the 85% of drug dissolved at 30 min criterion in SGF pH 1.2. However, in AB pH 4.5 and SIF pH 6.8, some formulations, including the comparator, did not achieve this dissolution percentage. The discrepant dissolution profiles also failed the ƒ2 similarity factor analysis, since none of the formulations showed values between 50 and 100 in the three dissolution media. Comparative dissolution profiles were not similar, considering that the main issues concerning the dissolution were evidenced for the comparator product. Hence, a revision in the regulatory norms in order to establish criteria to switch the comparator could result in an increased application of drugs based on biowaiver criteria |
| Disciplines: | Química, Medicina |
| Keyword: | Farmacología, Fluconazol, Vigilancia farmacológica, Bioexención, Perfil de disolución, Certificación |
| Keyword: | Pharmacology, Fluconazole, Pharmacological surveillance, Biowaiver, Dissolution profile, Certification |
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