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KMID : 0369820060360030209
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 3 p.209 ~ p.215
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Bioequivalence of SCD Zaltoprofen Tablet to Soleton(R) Tablet (Zaltoprofen 80 ㎎)
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강현아/Kang HA
박선애/김동호/김환호/윤화/김경란/류희두/박은자/조혜영/이용복/Park SA/Kim DH/Kim HH/Yun H/Kim KR/Yoo HD/Park EJ/Cho HY/Lee YB
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Abstract
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Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, Soleton® (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, 23.2±2.26 years in age and64.7±8.08 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen 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, Cmax and Tmax 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, Soleton® were 6.33, 5.91 and 17.7% for AUCt, Cmax and untransformed Tmax, 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.,log 1.01∼1og1.11 and log 0.928∼1og1.18 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to Soleton® tablet.
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KEYWORD
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Zaltoprofen, Soleton tablet, SCD Zaltoprofen tablet, Bioequivalence, HPLC
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