Abstract

PEREZ-GONZALEZ, M et al. Estudio Farmacocinético de dos formulaciones de Amoxicilina (500 mg T.I.D. en Cápsulas vs. 750 mg B.I.D. en tabletas dispersibles) en voluntarios humanos sanos. AVFT [online]. 2001, vol.20, n.1, pp.52-62. ISSN 0798-0264.

This study compared Amoxicilin 750 mg b.i.d., (dispersible tablets) and Amoxicilin 500 mg t.i.d., (capsules) in order to determine their bioequivalence. It was a two way, crossover study performed with nine healthy volunteers. Both formulations were administered for 6 consecutive days with a wash period of four weeks. Results at days 1 and 6 showed a rapid absorption of the drug, with a Cmax higher with 750 mg dosage b.i.d., (p<0.001). There was no signifficant difference in the time to obtain peak concentration with both formulations. Values of AUC_0-24h confirmed that both formulations were bioequivalent. lf we consider a MIC value of 1 µg/mL as a NCSCL, accepted value for otitis and upper respiratory mayor patogen strains with intermediate resistance and calculated how long plasma concentrations are below this value in our study, there was no real difference between formulations, that is strongly supported by the clinical observation that both formulations are equally efficient for the treatment of some important infectious pathologies.

Keywords : Amoxycillin; Pharmacokinetics; Antibiotics.