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

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...

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Veröffentlicht in:	International journal of pharmaceutics 2007-04, Vol.335 (1-2), p.106-113
Hauptverfasser:	Kerč, Janez, Opara, Jerneja
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Oral Adult Amoxicillin Amoxicillin-Potassium Clavulanate Combination - administration & dosage Amoxicillin-Potassium Clavulanate Combination - blood Amoxicillin-Potassium Clavulanate Combination - chemistry Amoxicillin-Potassium Clavulanate Combination - pharmacokinetics Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - blood Anti-Bacterial Agents - chemistry Anti-Bacterial Agents - pharmacokinetics Area Under Curve Bacteria - drug effects Bacteria - growth & development Biological and medical sciences Biological Availability Chemistry, Pharmaceutical Clavulanate Cross-Over Studies Delayed-Action Preparations Drug Compounding Floating capsule General pharmacology Half-Life Humans Hydrogen-Ion Concentration In vitro study Male Medical sciences Metabolic Clearance Rate Microbial Sensitivity Tests Pharmaceutical technology. Pharmaceutical industry Pharmacokinetic study Pharmacology. Drug treatments Reference Values Solubility Technology, Pharmaceutical Therapeutic Equivalency Therapeutic system
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Beschreibung
Zusammenfassung:	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, T1/2 and additionally for amoxicillin T4 and T2 were calculated from the plasma levels. The study confirmed enhanced pharmacokinetic parameters of a newly developed therapeutic system containing 1500mg of amoxicillin and 125mg of clavulanic acid. Prolonged time over MIC of amoxicillin in relation to a regular immediate release amoxicillin/clavulanate formulation was confirmed.
ISSN:	0378-5173 1873-3476
DOI:	10.1016/j.ijpharm.2006.11.007