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KCI 등재 SCOPUS
아세클로페낙 연질캡슬(클란자 에스 연질캡슬)의 개발
Development of Aceclofenac Soft Capsule (Clanza S Soft Capsule)
용철순 ( Yong Cheol Sun ) , 이경희 ( Lee Gyeong Hui ) , 최진석 ( Choe Jin Seog ) , 박병주 ( Park Byeong Ju ) , 정세현 ( Jeong Se Hyeon ) , 김용일 ( Kim Yong Il ) , 박상만 ( Park Sang Man ) , 배명수 ( Bae Myeong Su ) , 김귀자 ( Kim Gwi Ja ) , 유창훈 ( Yu Chang Hun ) , 강성룡 ( Kang Seong
약제학회지 34권 1호 49-55(7pages)
UCI I410-ECN-0102-2009-510-003328888

To develop and aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected a formula of aceclofenac soft capsule (Clanza S^(™), since it showed the fastest dissolution rate. Bioequivalence of aceclofenac tablet, Airtal^(™)(Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza S^(™)(Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age 20-25 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After oral administration of one tablet or capsule containing 100 ㎎ of aceclofenac, blood ws taken at predetermined time intervals and the concentration of aceclofenac in plasma wa determined with an HPLC method under UV detector. The pharmacokinetic parameters (C_(max), T_(max) and AUC_(t)) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmically transformed AUC_(t), C_(max) and T_(max) between Airtal tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, 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(1.250(e.g.log(0.81) - log(1.23) and log(0.89) - log(1.14)) for AUC_(t) and C_(max), respectively. Thus, the criteria of the KDFA guidelines for the equivalence was satisfied, indicating that Clanza S^(™) soft capsule is bioequivalent to Airtal^(™) tablet.

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