Abstract

PEREZ GUZMAN, Milena; OROBIO LERMA, Yenifer  and  BAENA ARISTIZABAL, Yolima. Comparative study for in vitro release of metformin of two immediate-release multisource products, marketed in Colombia. Rev. colomb. cienc. quim. farm. [online]. 2013, vol.42, n.2, pp.169-189. ISSN 0034-7418.

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.

Keywords : metformin; multisource; equivalence; in vitro dissolution; biowaiver.

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