Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in colombia

The objective of the study was to determine the equivalence of two multisource drug products of metformin tablets using in vitro testing. The in vitro dissolution profiles were done in phosphate buffer (pH 6.8), acetate buffer (pH 4.5), hydrochloric acid (pH 1.2) and two dissolution apparatus were used. Multivariate analysis for repeated measures design was employed to compare the percentage dissolved of the drug products. According to Food and Drug Administration (FDA) guidance for dissolution data equivalence, model independent approach was applied. This involves the use of difference factor (f1) and similarity factor (f2). The drug release from drug products was analyzed by various mathematical models such as zero order, firs order and Higuchi. The results showed that there were significant differences between the drug products, and for this reason it was not possible to demonstrate equivalence based in vitro assays.

• Autores: Pérez Guzmán, Milena; Orobio Lerma, Yenifer; Baena Aristizábal, Yolima
• Tipo de recurso: Article of journal
• Fecha de publicación: 2013
• Institución: Universidad Nacional de Colombia
• Repositorio: Universidad Nacional de Colombia
• Idioma: spa
• OAI Identifier: oai:repositorio.unal.edu.co:unal/49325
• Acceso en línea: https://repositorio.unal.edu.co/handle/unal/49325; http://bdigital.unal.edu.co/42782/; http://bdigital.unal.edu.co/42782/2/
• Palabra clave: metformina; multifuente; equivalencia; disolución in vitro; bioexención; metformin; multisource; equivalence; in vitro dissolution; biowaiver
• Rights: openAccess
• License: Atribución-NoComercial 4.0 Internacional