Abstract

MUNOZ-CARNAGO, ENRIQUE et al. Bioavalability study of Metformin 850 mg immediate-release tablets . CES Med. [online]. 2015, vol.29, n.2, pp.199-210. ISSN 0120-8705.

A bioavailability study was conducted in 12 healthy volunteers of both genders, aged between 18 and 26. Previous to the study, a bioanalytical method for determination of metformin in human plasma by high performance liquid chromatography with ultraviolet detector (HPLCUV) was validated, and proved to be selective, specific, linear, accurate precise, and therefore, suitable for analysis in plasma. Samples were collected from 0 to 24 hours after the oral administration of a single dose of metformin 850 mg immediate-release coated tablets, produced by Coaspharma S.A. Laboratories. Then, average pharmacokinetic parameters of the twelve volunteers were determined: area under the curve from time zero to last sampling time t (AUC_0--->t) 6856.89 ± 2073.8 ng.h/mL, area under the curve from time zero to infinite time (AUC_0--->∞) 7083.74 ± 2131.52 ng.h/ml, maximum concentration (C_max) 1299.02 ± 291.90 ng/mL, maximum time (t_max) 2.33 ± 0.47 h, half-life (t_1/2) 2.50 ± 0.84 h and apparent elimination constant (K_e) of 0.31 ± 0.12 h^-1. These results are similar between the volunteers and no adverse effect was observed. Also, the results are in agree with those reported in literature.

Keywords : Metformin; Biological bioavailability; High performance liquid chromatography; Pharmacokinetics; Ultraviolet spectrophotometry.

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