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KMID : 0369820050350030179
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 3 p.179 ~ p.185
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Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100mg)
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조혜영/Cho HY
박은자/강현아/김세미/박찬호/오인준/임동구/이명희/이용복/Park EJ/Kang HA/Kim SM/Park CH/Oh IJ/Lim DK/Lee MH/Lee YB
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Abstract
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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±1.43 years in age and 64.82±6.77 kg in body weight, were divided into two groups and a randomized 2×2 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 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 Surfolase, were -1.64, -3.33 and -0.92% 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.,log0.93∼log1.05andlog0.88∼log1.05 for AUCt, and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.
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KEYWORD
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Acebrophylline, Burophil, Surfolase, Bioequivalence, HPLC
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