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ArticleAuthors
Al-Talla, ZeyadAkrawi, Sabah H
Tolley, Luke T
Sioud, Salim
Zaater, Mohammed F
Emwas, Abdul-Hamid M.
KAUST Department
Analytical Chemistry Core LabImaging and Characterization Core Lab
Date
2011-10Permanent link to this record
http://hdl.handle.net/10754/325348
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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. Methods and 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. Conclusion: 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. 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.Citation
Al-Talla Z, Akrawi, Tolley, Zaater, Emwas, et al. (2011) Bioequivalence assessment of two formulations of ibuprofen. DDDT: 427. doi:10.2147/DDDT.S24504.Publisher
Dove Medical Press Ltd.PubMed ID
22087062PubMed Central ID
PMC3210071ae974a485f413a2113503eed53cd6c53
10.2147/DDDT.S24504
Scopus Count
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