Gliclazide: Biopharmaceutics Characteristics to Discuss the Biowaiver of Immediate and Extended Release Tablets
| Autor: | Lorena Ulhôa Araújo, Tamires Guedes Caldeira, Neila Márcia Silva-Barcellos, Bruna de Carvalho Mapa, Jacqueline de Souza |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Drug
biopharmaceutics characteristics media_common.quotation_subject dissolution 030209 endocrinology & metabolism essential medicines gliclazide Bioequivalence Pharmacology lcsh:Technology 030226 pharmacology & pharmacy Dosage form lcsh:Chemistry 03 medical and health sciences 0302 clinical medicine Pharmacokinetics medicine General Materials Science Gliclazide lcsh:QH301-705.5 Instrumentation media_common Fluid Flow and Transfer Processes lcsh:T business.industry Process Chemistry and Technology Biopharmaceutics General Engineering Biopharmaceutics Classification System biowaiver lcsh:QC1-999 Computer Science Applications Bioavailability lcsh:Biology (General) lcsh:QD1-999 lcsh:TA1-2040 permeability lcsh:Engineering (General). Civil engineering (General) business lcsh:Physics medicine.drug |
| Zdroj: | Applied Sciences, Vol 10, Iss 7131, p 7131 (2020) |
| ISSN: | 2076-3417 |
| DOI: | 10.3390/app10207131 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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