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JAC Advance Access originally published online on January 14, 2003
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Journal of Antimicrobial Chemotherapy (2003) 51, 373-378
© 2003 The British Society for Antimicrobial Chemotherapy

Identical pattern of highly variable absorption of clavulanic acid from four different oral formulations of co-amoxiclav in healthy subjects

Tom B. Vree1,*, Erik Dammers2 and Peter S. Exler3

1 Institute for Anaesthesiology, University Medical Centre Sint Radboud, PO Box 9101, 6500 HB Nijmegen; 2 DADA Consultancy, Dennenstraat 109, 6543 JR Nijmegen; 3 Disphar International, Winkelskamp 6, 7522 PZ Hengelo (Gld), The Netherlands

Received 26 October 2001; returned 20 June 2002; revised 30 October 2002; accepted 6 November 2002

The aims of this investigation were to calculate the pharmacokinetic parameters of amoxicillin and clavulanic acid, and to identify parameters that may affect their observed differences in absorption. Data were obtained from plasma concentration–time curves from four different open, randomized, two-treatment, two-period, two-sequence, crossover Phase I bioequivalence studies, with the following co-amoxiclav formulations: tablets 250/125, 500/125 and 875/125 mg, or 10 mL of an oral suspension 250/62.5 mg per 5 mL. Data from 144 subjects and 288 drug administrations were available for evaluation. After a 125 mg clavulanic acid dose (administered as potassium clavulanate) for all four different formulations, the clavulanic acid AUCt data ranged from 1.5 to 8 mg·h/L, varying by a factor of 5. The absorption of clavulanic acid was not related to the absorption of amoxicillin, or demographic factors, and we were unable to identify the reasons for the large variability in the absorption of clavulanic acid. We conclude that the absorption of clavulanic acid, after oral administration, is highly variable and may vary over a five-fold range between patients.

Keywords: amoxicillin-clavulanate, co-amoxiclav, amoxiclav, pharmacokinetics, variable absorption, AUC, amoxicillin/clavulanate ratio

* Corresponding author. Tel: +31-24-361-5363; Fax: +31-24-354-0462; E-mail: T.Vree{at}anes.azn.nl


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