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KMID : 0369820060360060405
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 6 p.405 ~ p.411
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Bioequivalence of S-napine Tablet 10mg to Alesion Tablet (Epinastine HCl 10mg)
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Kang Hyun-Ah
Yoon Hwa
Kim Se-Mi
Cho Hae-Young
Kim Dong-Ho
Park Sun-Ae
Kim Hwan-Ho
Lee Yong-Bok
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Abstract
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Epinastine is an antiallergic drug effective for bronchial asthma, allergic rhinitis, urticaria and dermatitis. Epinastine is topically active, direct H1-receptor antagonist and an inhibitor of release of histamine from the mast cell. The purpose of the present study was to evaluate the bioequivalence of two epinastine hydrochloride tablets, Alesion Tablet(Boehringer Ingelheim Korea Ltd.) and S-napine tablet 10mg(Sam Chun Dang Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration(KFDA). The realease of epinastine from the two epinastine formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with varioius dissolution media(pH 1.2, 4.0, 6.8 bufer solution and water). Twenty six healthy male subjects, 23.35±1.57 years in age and 66.29±10.61 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 20mg as epinastine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of eponastine in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as AUCt,Cmax and Tmax were caculated 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, Alesion tablet, were 1.50, 1.46 and -13.48% for AUCt,Cmax and 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 0.95~log 1.12 and log 0.93~log 1.10 for AUCt an Cmax, respectively). Thus, the citeria of the KFDA bioequivalence guideline were satisfied, indicating S-napine tablet 10mg was bioequivalent to Alesion tablet.
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KEYWORD
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Epinastine hydrochloride, Alesion, S-napine, Bioequivalence, HPLC
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