Bioequivalence assessment of two formulations of ibuprofen
dc.contributor.author | Al-Talla, Zeyad | |
dc.contributor.author | Akrawi, Sabah H | |
dc.contributor.author | Tolley, Luke T | |
dc.contributor.author | Sioud, Salim | |
dc.contributor.author | Zaater, Mohammed F | |
dc.contributor.author | Emwas, Abdul-Hamid M. | |
dc.date.accessioned | 2014-08-27T09:48:33Z | |
dc.date.available | 2014-08-27T09:48:33Z | |
dc.date.issued | 2011-10 | |
dc.identifier.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. | |
dc.identifier.issn | 11778881 | |
dc.identifier.pmid | 22087062 | |
dc.identifier.doi | 10.2147/DDDT.S24504 | |
dc.identifier.uri | http://hdl.handle.net/10754/325348 | |
dc.description.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. 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. | |
dc.language.iso | en | |
dc.publisher | Informa UK Limited | |
dc.rights | © 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd. | |
dc.rights | This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. | |
dc.rights | Archived with thanks to Drug Design, Development and Therapy | |
dc.subject | Bioequivalence study | |
dc.subject | Ibuprofen | |
dc.subject | Pharmacokinetics | |
dc.subject | doloraz | |
dc.subject | ibuprofen | |
dc.subject | indometacin | |
dc.subject | unclassified drug | |
dc.subject | absence of side effects | |
dc.subject | accuracy | |
dc.subject | adult | |
dc.subject | area under the curve | |
dc.subject | bioequivalence | |
dc.subject | blood sampling | |
dc.subject | controlled study | |
dc.subject | crossover procedure | |
dc.subject | drug bioavailability | |
dc.subject | drug blood level | |
dc.subject | drug determination | |
dc.subject | drug formulation | |
dc.subject | drug half life | |
dc.subject | drug safety | |
dc.subject | drug stability | |
dc.subject | drug structure | |
dc.subject | drug tolerability | |
dc.subject | food and drug administration | |
dc.subject | freeze thawing | |
dc.subject | high performance liquid chromatography | |
dc.subject | human experiment | |
dc.subject | intermethod comparison | |
dc.subject | normal human | |
dc.subject | outcome assessment | |
dc.subject | plasma concentration-time curve | |
dc.subject | quality control | |
dc.subject | randomized controlled trial | |
dc.subject | sensitivity and specificity | |
dc.subject | single drug dose | |
dc.subject | time to maximum plasma concentration | |
dc.subject | ultraviolet radiation | |
dc.subject | Adult | |
dc.subject | Area Under Curve | |
dc.subject | Calibration | |
dc.subject | Cross-Over Studies | |
dc.subject | Drug Stability | |
dc.subject | Middle Aged | |
dc.subject | Reproducibility of Results | |
dc.subject | Therapeutic Equivalency | |
dc.subject | Young Adult | |
dc.title | Bioequivalence assessment of two formulations of ibuprofen | |
dc.type | Article | |
dc.contributor.department | Analytical Chemistry Core Lab | |
dc.contributor.department | Imaging and Characterization Core Lab | |
dc.identifier.journal | Drug Design, Development and Therapy | |
dc.identifier.pmcid | PMC3210071 | |
dc.eprint.version | Publisher's Version/PDF | |
dc.contributor.institution | College of Pharmacy, Al-Ain University, Al-Ain, United Arab Emirates | |
dc.contributor.institution | Department of Chemistry and Biochemistry, Southern Illinois University Carbondale, Carbondale, IL, United States | |
dc.contributor.institution | Department of Chemistry, Jordan University of Science and Technology, Irbid, Jordan | |
dc.contributor.affiliation | King Abdullah University of Science and Technology (KAUST) | |
kaust.person | Al-Talla, Zeyad | |
kaust.person | Sioud, Salim | |
kaust.person | Emwas, Abdul-Hamid M. | |
refterms.dateFOA | 2018-06-13T15:16:18Z |