title: A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation.
abstract: 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.
authors.affiliation: Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Verovškova 57, 1526 Ljubljana, Slovenia. Electronic address: janez.kerc@sandoz.com.
authors.forename: Janez
authors.initials: J
authors.lastname: Kerč
authors.affiliation: Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Verovškova 57, 1526 Ljubljana, Slovenia.
authors.forename: Jerneja
authors.initials: J
authors.lastname: Opara
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry* / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001419:Bacteria / Q000187:drug effects / Q000254:growth & development; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004339:Drug Compounding; D006207:Half-Life; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008657:Metabolic Clearance Rate; D008826:Microbial Sensitivity Tests; D012016:Reference Values; D012995:Solubility; D013678:Technology, Pharmaceutical; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D019980:Amoxicillin-Potassium Clavulanate Combination