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Comparator product issues for biowaiver implementation: the case of Fluconazole
Lazo, Raul Edison Luna; Teleginski, Lilian Klein; Maciel, Aline Biggi; Silva, Marcos Antônio Segatto; Mendes, Cassiana; Bernardi, Larissa Sakis; Murakami, Fábio Seigi; Sonvico, Fabio; Oliveira, Paulo Renato.
  • Lazo, Raul Edison Luna; Universidade Estadual do Centro-Oeste. Department of Pharmacy. Postgraduate Programme in Pharmaceutical Sciences. Guarapuava. BR
  • Teleginski, Lilian Klein; Universidade Estadual do Centro-Oeste. Department of Pharmacy. Postgraduate Programme in Pharmaceutical Sciences. Guarapuava. BR
  • Maciel, Aline Biggi; Universidade Estadual do Centro-Oeste. Department of Pharmacy. Postgraduate Programme in Pharmaceutical Sciences. Guarapuava. BR
  • Silva, Marcos Antônio Segatto; Universidade Federal de Santa Catarina. Department of Pharmaceutical Sciences. Postgraduate Programme in Pharmacy. Florianópolis. BR
  • Mendes, Cassiana; Universidade Federal de Santa Catarina. Department of Chemestry. Study group in Polymeric Materials. Florianópolis. BR
  • Bernardi, Larissa Sakis; Universidade Estadual do Centro-Oeste. Department of Pharmacy. Postgraduate Programme in Pharmaceutical Sciences. Guarapuava. BR
  • Murakami, Fábio Seigi; Universidade Federal do Paraná. Department of Pharmaceutical Sciences. Postgraduate Programme in Pharmacy. Curitiba. BR
  • Sonvico, Fabio; University of Parma. Department of Food and Drug. Parma. IT
  • Oliveira, Paulo Renato; Universidade Estadual do Centro-Oeste. Department of Pharmacy. Postgraduate Programme in Pharmaceutical Sciences. Guarapuava. BR
Braz. J. Pharm. Sci. (Online) ; 58: e19710, 2022. tab, graf
Article in English | LILACS | ID: biblio-1384010
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
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Full text: Available Index: LILACS (Americas) Main subject: Fluconazole Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2022 Type: Article Affiliation country: Brazil / Italy Institution/Affiliation country: Universidade Estadual do Centro-Oeste/BR / Universidade Federal de Santa Catarina/BR / Universidade Federal do Paraná/BR / University of Parma/IT

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Full text: Available Index: LILACS (Americas) Main subject: Fluconazole Language: English Journal: Braz. J. Pharm. Sci. (Online) Journal subject: Farmacologia / Terapˆutica / Toxicologia Year: 2022 Type: Article Affiliation country: Brazil / Italy Institution/Affiliation country: Universidade Estadual do Centro-Oeste/BR / Universidade Federal de Santa Catarina/BR / Universidade Federal do Paraná/BR / University of Parma/IT