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KMID : 0941820060160010052
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Korean Journal of Clinical Pharmacy
2006 Volume.16 No. 1 p.52 ~ p.56
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Pharmacokinetic Study of Aceclofenac and its Metabolites, and Application to Bioequivalence Study
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Ihm Chun-Hwa
Hwang In-Taek
Kim Eun-Young
Kang Won-Ku
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Abstract
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Aceclofenac, a nonsteroidal antiinflammatory agent of phenylacetic acid type, has been used for rheumatoid arthritis and osteoarthritis. Although the metabolic pathway of aceclofenac is relatively well-known in vitro, pharmacokinetic profiles of its three major metabolites are still unclear in human. The present study was designed to investigate hparmacokinetic profiles of the metabolites of aceclofenac, and to evaluate the bioequivalence of the generic preparation of aceclofenac 100mg tablet. Blood samples were serially collected for a period of 12 hours following a single oral adminstration of 100mg aceclofenac in 20 healthy human volunteers. A simple protein precipitation with acetonitrile was employed to purify those substances from plasma. Aceclofemac, diclofenac, 4’-hydroxyaceclofenac and 4’-hydroxy- diclofenac in heparinized plasma were simultaneously measured with flufenamic acid, an internal standard, using HPLC coupeld to a tandem mass spectrometer. Time courses of 4’-hydroxydiclofenax, diclofenac and aceclofenac plasma con- centrations were clearly revealed, and the pharmacokinetic properties were analyzed. The 90% confidence intervals for the ratios of test/reference for log-transformed AUC and Cmax lie within 0.080-1.25.
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KEYWORD
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aceclofenac, metabolites, LC/MS/MS, pharmacokinetics, bioequivalence
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