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dc.contributor.authorAl-Talla, Zeyad
dc.contributor.authorAkrawi, Sabah H
dc.contributor.authorTolley, Luke T
dc.contributor.authorSioud, Salim
dc.contributor.authorZaater, Mohammed F
dc.contributor.authorEmwas, Abdul-Hamid M.
dc.date.accessioned2014-08-27T09:48:33Z
dc.date.available2014-08-27T09:48:33Z
dc.date.issued2011-10
dc.identifier.citationAl-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.issn11778881
dc.identifier.pmid22087062
dc.identifier.doi10.2147/DDDT.S24504
dc.identifier.urihttp://hdl.handle.net/10754/325348
dc.description.abstractBackground: 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.isoen
dc.publisherDove Medical Press Ltd.
dc.rights© 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.
dc.rightsThis is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
dc.rightsArchived with thanks to Drug Design, Development and Therapy
dc.subjectBioequivalence study
dc.subjectIbuprofen
dc.subjectPharmacokinetics
dc.subjectdoloraz
dc.subjectibuprofen
dc.subjectindometacin
dc.subjectunclassified drug
dc.subjectabsence of side effects
dc.subjectaccuracy
dc.subjectadult
dc.subjectarea under the curve
dc.subjectbioequivalence
dc.subjectblood sampling
dc.subjectcontrolled study
dc.subjectcrossover procedure
dc.subjectdrug bioavailability
dc.subjectdrug blood level
dc.subjectdrug determination
dc.subjectdrug formulation
dc.subjectdrug half life
dc.subjectdrug safety
dc.subjectdrug stability
dc.subjectdrug structure
dc.subjectdrug tolerability
dc.subjectfood and drug administration
dc.subjectfreeze thawing
dc.subjecthigh performance liquid chromatography
dc.subjecthuman experiment
dc.subjectintermethod comparison
dc.subjectnormal human
dc.subjectoutcome assessment
dc.subjectplasma concentration-time curve
dc.subjectquality control
dc.subjectrandomized controlled trial
dc.subjectsensitivity and specificity
dc.subjectsingle drug dose
dc.subjecttime to maximum plasma concentration
dc.subjectultraviolet radiation
dc.subjectAdult
dc.subjectArea Under Curve
dc.subjectCalibration
dc.subjectCross-Over Studies
dc.subjectDrug Stability
dc.subjectMiddle Aged
dc.subjectReproducibility of Results
dc.subjectTherapeutic Equivalency
dc.subjectYoung Adult
dc.titleBioequivalence assessment of two formulations of ibuprofen
dc.typeArticle
dc.contributor.departmentAnalytical Chemistry Core Lab
dc.contributor.departmentImaging and Characterization Core Lab
dc.identifier.journalDrug Design, Development and Therapy
dc.identifier.pmcidPMC3210071
dc.eprint.versionPublisher's Version/PDF
dc.contributor.institutionCollege of Pharmacy, Al-Ain University, Al-Ain, United Arab Emirates
dc.contributor.institutionDepartment of Chemistry and Biochemistry, Southern Illinois University Carbondale, Carbondale, IL, United States
dc.contributor.institutionDepartment of Chemistry, Jordan University of Science and Technology, Irbid, Jordan
dc.contributor.affiliationKing Abdullah University of Science and Technology (KAUST)
kaust.personAl-Talla, Zeyad
kaust.personSioud, Salim
kaust.personEmwas, Abdul-Hamid M.
refterms.dateFOA2018-06-13T15:16:18Z


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