|
KMID : 0369820060360030201
|
|
Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 3 p.201 ~ p.207
|
|
|
Bioequivalence of Tylicol ER Tablet to Tylenol(R) ER Tablet (Acetaminophen 650 ㎎)
|
|
강현아/Kang HA
김동호/박선애/윤화/김경란/박은자/조혜영/이용복/Kim DH/Park SA/Yun H/Kim KR/Park EJ/Cho HY/Lee YB
|
|
|
Abstract
|
|
|
|
Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ 수식 이미지 ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ 수식 이미지 years in age and $65.6{\pm}8.03$ 수식 이미지 kg in body weight, were divided into two groups and a randomized $2{\times}2$ 수식 이미지 cross-over study was employed. After a single tablet containing 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. The pharmacokinetic parameters such as $AUC_t$ 수식 이미지, $C_{max}$ 수식 이미지 and $T_{max}$ 수식 이미지 were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ 수식 이미지, $C_{max}$ 수식 이미지 and untransformed $T_{max}$ 수식 이미지. The results showed that the differences between two formulations based on the reference drug, $Tylenol^{\circledR}$ 수식 이미지 ER, were 2.84, 1.89 and -1.36% for $AUC_t$ 수식 이미지, $C_{max}$ 수식 이미지 and $T_{max}$ 수식 이미지, 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 $0.987{\sim}log$ 수식 이미지 1.08 and log $0.944{\sim}log$ 수식 이미지 1.17 for $AUC_t$ 수식 이미지 and $C_{max}$ 수식 이미지, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ 수식 이미지 ER tablet.
|
|
|
KEYWORD
|
|
|
Acetaminophen, Tylenol ER, Tylicol ER, Bioequivalence, HPLC
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|