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KMID : 0369820110410020117
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Jorunal of Korean Pharmaceutical Sciences
2011 Volume.41 No. 2 p.117 ~ p.123
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Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)
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Kang Hyun-Ah
Cho Hea-Young
Lee Yong-Bok
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Abstract
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Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin® tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, 22.83±1.86 years in age and 69.92±9.14 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. 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 computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and un-transformed Tmax. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin® tablet, were 2.03, 2.99 and -9.49% for AUCt, Cmax, and Tmax, respectively. There were no equence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin® tablet.
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KEYWORD
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Loxoprofen sodium, Hana loxoprofen sodium tablet, Dongwha Loxonin(R) tablet, Bioequivalence, Online column-switching HPLC
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