A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation.

Author(s): Kerc J, Opara J

Affiliation(s): Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Verovskova 57, 1526 Ljubljana, Slovenia. janez.kerc@sandoz.com

Publication date & source: 2007-04-20, Int J Pharm., 335(1-2):106-13. Epub 2006 Nov 6.

Publication type: Randomized Controlled Trial

A new peroral amoxicillin/clavulanate therapeutic system composed of immediate release tablet and controlled release floating capsule was developed and evaluated by in vivo bioavailability study. Pharmacokinetic (PK) parameters for amoxicillin and clavulanic acid of the new therapeutic systems: AUCt, AUCi, (AUCt/AUCi), Cmax, Tmax, kel, T(1/2) and additionally for amoxicillin T(4) and T(2) were calculated from the plasma levels. The study confirmed enhanced pharmacokinetic parameters of a newly developed therapeutic system containing 1500 mg of amoxicillin and 125 mg of clavulanic acid. Prolonged time over MIC of amoxicillin in relation to a regular immediate release amoxicillin/clavulanate formulation was confirmed.