세프질® 정 250밀리그람 (세프프로질 250밀리그람)에 대한 프로세질 정 250밀리그람의 생물학적동등성

Abstract

Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin,and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets,Cefzil® tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, 24.00±1.53 years in age and 69.77±9.99 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered,blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax on the basis of total-cefprozil were calculated,and computer program (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, Cefzil® tablets, were -0.81%, -3.00% and -6.83% 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 0.9515~log 1.0454and log 0.9613~log 1.0465 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to Cefzil® tablet.