Browse > Article
http://dx.doi.org/10.4333/KPS.2006.36.3.201

Bioequivalence of Tylicol ER Tablet to Tylenol® ER Tablet (Acetaminophen 650 mg)  

Kang, Hyun-Ah (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University)
Kim, Dong-Ho (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University)
Park, Sun-Ae (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University)
Yun, Hwa (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University,Clinical Trial Center, Chonnam National University Hospital)
Kim, Kyung-Ran (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University)
Park, Eun-Ja (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University)
Cho, Hea-Yeong (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University,Clinical Trial Center, Chonnam National University Hospital)
Lee, Yong-Bok (Institute of Bioquivalence and, Bridging Study, College of Pharmacy, Chonnam National University,Clinical Trial Center, Chonnam National University Hospital)
Publication Information
Journal of Pharmaceutical Investigation / v.36, no.3, 2006 , pp. 201-207 More about this Journal
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, $Tylenol^{\circledR}$ 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, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ 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 $AUC_t$, $C_{max}$ 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, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% 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 $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.
Keywords
Acetaminophen; Tylenol ER; Tylicol ER; Bioequivalence; HPLC;
Citations & Related Records
연도 인용수 순위
  • Reference
1 식품의약품안전청 고시 제 2002-60호, 생물학적동등성시험기준(20020.11.22)
2 M.A. Campanero, B. Calahorra, E. Garcia-Quetglas, A. Lopez-Ocariz and J. Honorato, Rapid liquid chromatographic assay for the determination of acetaminophen in plasma after propacetamol administration: application to pharmacokinetic studies, J. Pharm. Biomed. Anal., 20(1-2), 327-334 (1999)   DOI   ScienceOn
3 Statistical Solutions Ltd., Equiv Tes$t^{\circledR}$ 2.0, UK (2001)
4 Food and Drug Administration (FDA): Guidance for Industry; Waiver of in vivo bioavailability and bioequivalence study for immediate-release solid oral dosage forms based on a biopharmaceutics classification system, Center for Drug Evaluation and Research (CDER), August (2000)
5 식품의약품안전청 고시 제 1999-67호, 의약품임상시험관리기준(2000.1.4)
6 Martindale, The complete drug reference, 32 editions 1999, p. 72-75 (1999)
7 R.J. Flower and J.R. Vane, Inhibition of prostaglandin synthetase in brain explains the anti-pyretic activity of acetaminophen (4-acetamidophenol), Nature, 240, 410-411 (1972)   DOI   ScienceOn
8 C.M. Stork, S. Rees, M.A. Howland, L. Kaplan, L. Goldfrank and R.S. Hoffinan, Pharmacokinetics of extended relief vs regular release Tylenol in simulated human overdose, Clin. Toxicol., 34(2), 157-162 (1996)   DOI   ScienceOn