Estudo da biodisponibilidade comparativa de duas formulações de fenoximetilpenicilina / Compartive bioavailability study of two phenoxymethylpenicillin


IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia




This study aimed to compare the bioequivalence between Phenoxymethylpenicillin tablets (500.000 UI), a test formulation Meracilina by Aché Laboratórios S/A, and the Pen-Ve-Oral® tablet formulation elaborated by Eurofarma Laboratórios Ltda., Brazil, in healthy human volunteers of both sexes. The study was carried out by using an open, randomized-crossover design, consisting of a two-period treatment, in which the volunteers received, in each period, the test formulation or the reference formulation, with a seven-day washout interval. A single dose of each formulation was administered to 26 healthy volunteers. The treatment sequence was determined by a randomization list, automatically produced by the Clinical Trial Medicine Control System. Plasma samples were obtained over a 36-hour period. Phenoxymethylpenicillin concentrations were analyzed by high pressure liquid chromatography and UV-visible detection (HPLC-UV). From the Phenoxymethylpenicillin plasma concentration vs. time curves, the following pharmacokinetic parameters were obtained: ASC0-t, ASC0-inf, and Cmax. The mean of Meracilina/Pen-Ve-Oral® 500.000 UI percent geometric mean was 99.89% for AUC0-t, 100.86% for AUC0-∞ and 101.11% for Cmax. The 90% confidence intervals were 94.62 – 105.46%, 95.22 – 106.83% and 98.61 – 103.87%, respectively. Considering the results of Cmax. and AUC0-t within the confidence interval between 80% and 125% proposed by the Brazilian National Agency for Sanitary Surveillance (Anvisa) and for the US Food and Drug Administration (FDA), it was concluded that Meracilina tablet (500.000UI) by Eurofarma Laboratórios Ltda. is bioequivalent to Pen-Ve-Oral® tablet for both rate and extent of bioavailability


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