Clinical study on the bioequivalence of two tablet formulations of flurbiprofen

• Published in: European journal of drug metabolism and pharmacokinetics Vol. 34; no. 1; pp. 1 - 5
• Main Authors: Ozbay, Latif, Unal, Durisehvar Ozer, Cakici, Iclal, Fenercioglu, Ayşen, Erol, Dilek
• Format: Journal Article
• Language: English
• Published: Paris Springer-Verlag 01-01-2009; Médecine & hygiène
• Subjects: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Area Under Curve; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Cross-Over Studies; Double-Blind Method; Flurbiprofen - administration & dosage; Flurbiprofen - pharmacokinetics; Flurbiprofen - therapeutic use; Human Physiology; Humans; Male; Medical Biochemistry; Medical sciences; Middle Aged; Pharmaceutical Sciences/Technology; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pharmacy; Reproducibility of Results; Spectrophotometry, Ultraviolet; Tablets; Therapeutic Equivalency; Young Adult; Bioequivalence; flurbiprofen; pharmacokinetics; Non steroidal antiinflammatory agent; Prostaglandin-endoperoxide synthase; Enzyme; Formulation; Dosage form; Enzyme inhibitor; Arylpropionic acid derivatives; Tablet; Oxidoreductases; Pharmacokinetics; Flurbiprofen
• ISSN: 0378-7966; 2107-0180
• DOI: 10.1007/BF03191376

Summary
Flurbiprofen (CAS 5104-49-4) is a member of phenylaikanoic acid derivative group of nonsteroid anti-inflammatory drugs. It exhibits anti-inflammatory, analgesic and antipyretic activities. Two different tablets containing flurbiprofen (FLU) were investipted in 24 healthy volunteers to prove the bioequivalence between both treatments after single oral dose administrations. Fluroben
®
100 mg tablet and 100 mg tablet of the originator product were used as test and reference preparation respectively. The study was performed open label, randomized, two period cross-over design with 15 days wash out period. Blood samples were taken up to 24 hours for pharmacokinetic profiling. The plasma concentrations of flurbiprofen were determined with validated HPLC-UV method. Maximum plasma concentration (C
max
) of FLU 19 143.65 ng/ml and 19 164.22 ng/ml were found for test and reference formulation respectively. Areas under the plasma concentration time curve AUC
0-∞
of 118 501.4 ng.h/ml and lii 339.8 ng.h/ml were calculated test and reference formulation respectively. Primary target parameters AUC
0-∞
and C
max
, both of them were tested parametrically by analysis of variance (ANOVA); 90% confidence intervals were between 100.5%–111.18% for AUC
0-∞
and 87.6%–115.0% for C
max
. All these values were within the acceptance range (80%–125%) for bioequivalence studies.