Earticle

초록

영어

Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active β2-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, Bambec® tablet 10 mg (Yuhan Co., Ltd.) and Bambucol
tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, 23.86±1.65 years in age and 68.98±9.58 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching 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 with K-BE Test 2002 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, Bambec®, were -8.10%, -3.82% and 12.65% 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 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to Bambec® tablet 10 mg.

목차

Abstract
 실험재료 및 방법
  시약 및 기기
  비교용출실험
  피험자 선정
  약물 투약 및 혈액 채취
  혈청 중 염산밤부테롤의 정량
  약물속도론적 파라미터의 분석
 결과 및 고찰
  비교용출시험
  혈청 중 염산밤부테롤의 정량
  혈청 중 염산밤부테롤 농도 추이
  평가항목에 대한 통계학적 고찰
 결론
 참고문헌

키워드

저자

• 조혜영 [ Hea-Young Cho | 식품의약품안전청 임상제도과 ]
• 최지훈 [ Ji-Hoon Choi | 전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소 ]
• 류희두 [ Hee-Doo Yoo | 전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소 ]
• 이용복 [ Yong-Bok Lee | 전남대학교 약학대학 부속 생물학적동등성 및 가교시험연구소 ] Correspondence to

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615