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설포라제 캡슐(아세브로필린 100 mg)에 대한 부로필 캡슐의 생물학적 동등성

Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100 mg)

  • 조혜영 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 박은자 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 강현아 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 김세미 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 박찬호 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 오인준 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 임동구 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터) ;
  • 이명희 (광주기독병원) ;
  • 이용복 (전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소, 전남대학교 병원 임상시험센터)
  • Cho, Hea-Young (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Park, Eun-Ja (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Kang, Hyun-Ah (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Kim, Se-Mi (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Park, Chan-Ho (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Oh, In-Joon (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Lim, Dong-Koo (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital) ;
  • Lee, Myung-Hee (Kwangju Christian Hospital) ;
  • Lee, Yong-Bok (College of Pharmacy, Institute of Bioequivalence and Bridging Study, Chonnam National University, Clinical Trial Center, Chonnam National University Hospital)
  • 발행 : 2005.06.20

초록

Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline 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, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug Surfolase, were -1.64, -3.33 and -0.92% for $AUC_t$, $C_{max}$ and $T_{max}$, 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

키워드

참고문헌

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