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KMID : 0369820060360010067
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 1 p.67 ~ p.73
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Bioequivalence of Lornocam Tablet to Xefo(R) Tablet (Lornoxicam 4 mg)
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강현아/Kang HA
조혜영/이용복/Cho HY/Lee YB
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Abstract
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Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, Xefo® (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, 24.39±1.95 years in age and 68.63±7.25 kg in body weight, were divided into two groups and a randomized 2\time2 cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as AUCt,CmaxandTmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt,Cmax and untransformed Tmax. The results showed that the differences between two formulations based on the reference drug, Xefo®, were -1.56%, 2.16% and -17.12% for AUCt,CmaxandTmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log0.90∼log1.05 and log0.88∼log1.17 for AUCtandCmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to Xefo® tablet.
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KEYWORD
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Lornoxicam, Xefo, Lornocam, Bioequivalence, HPLC
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