title: Bioequivalence assessment of two formulations of ibuprofen.
abstract: BACKGROUND
  This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz(®), produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen(®), manufactured by Boots Company, Nottingham, UK.
  
  
  RESULTS
  A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration.
  
  
  CONCLUSIONS
  Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen.
authors.affiliation: Analytical and NMR Core Laboratories, King Abdullah University of Science and Technology, Thuwal, Kingdom of Saudia Arabia. zeyad.talla@kaust.edu.sa
authors.forename: Zeyad A
authors.initials: ZA
authors.lastname: Al-Talla
authors.forename: Sabah H
authors.initials: SH
authors.lastname: Akrawi
authors.forename: Luke T
authors.initials: LT
authors.lastname: Tolley
authors.forename: Salim H
authors.initials: SH
authors.lastname: Sioud
authors.forename: Mohammed F
authors.initials: MF
authors.lastname: Zaater
authors.forename: Abdul-Hamid M
authors.initials: AH
authors.lastname: Emwas
mesh_terms: D000328:Adult; D019540:Area Under Curve; D002138:Calibration; D018592:Cross-Over Studies; D004355:Drug Stability; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D007052:Ibuprofen
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