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Title: Gliclazide : biopharmaceutics characteristics to discuss the biowaiver of immediate and extended release tablets.
Authors: Mapa, Bruna de Carvalho
Araújo, Lorena Ulhôa
Barcellos, Neila Marcia Silva
Caldeira, Tamires Guedes
Souza, Jacqueline de
Keywords: Essential medicines
Issue Date: 2020
Citation: MAPA, B. de C. et al. Gliclazide: biopharmaceutics characteristics to discuss the biowaiver of immediate and extended release tablets. Applied Sciences-Basel, v. 10, p. 7131, 2020. Disponível em: <>. Acesso em: 10 jun. 2021.
Abstract: The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic profile and few side effects. Thus, it is also considered by WHO and the International Pharmaceutical Federation (FIP) as a drug candidate to biowaiver, which is the evaluation of how favorable the biopharmaceutics characteristics are in order to obtain waiver from the relative bioavailability/bioequivalence (RB/BE) studies to register new medicines. This paper presents a review about the solubility, permeability and dissolution of gliclazide. A critical analysis of the information allowed to identify gliclazide as a Biopharmaceutics Classification System (BCS) Class II drug. Therefore, new drugs in immediate release dosage forms will not be eligible for biowaiver. Regarding the extended release dosage forms, besides the limited solubility, no information on the comparative dissolution profile was found, which would be necessary to analyze a possible biowaiver for a smaller dosage. It can be concluded that the registration of new medicines containing gliclazide must undergo RB/BE studies, since there is not enough evidence to recommend the replacement and waiver of such studies for immediate and extended release formulations.
ISSN: 2076-3417
metadata.dc.rights.license: This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( Fonte: o PDF do artigo.
Appears in Collections:DEFAR - Artigos publicados em periódicos

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