Bioequivalence assessment of two formulations of ibuprofen

Handle URI:
http://hdl.handle.net/10754/325348
Title:
Bioequivalence assessment of two formulations of ibuprofen
Authors:
Al-Talla, Zeyad; Akrawi, Sabah H; Tolley, Luke T; Sioud, Salim H; Zaater, Mohammed F; Emwas, Abdul-Hamid M
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.
KAUST Department:
Analytical Core Lab
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.
Journal:
Drug Design, Development and Therapy
Issue Date:
19-Oct-2011
DOI:
10.2147/DDDT.S24504
PubMed ID:
22087062
PubMed Central ID:
PMC3210071
Type:
Article
ISSN:
11778881
Appears in Collections:
Articles; Analytical Core Lab

Full metadata record

DC FieldValue Language
dc.contributor.authorAl-Talla, Zeyaden
dc.contributor.authorAkrawi, Sabah Hen
dc.contributor.authorTolley, Luke Ten
dc.contributor.authorSioud, Salim Hen
dc.contributor.authorZaater, Mohammed Fen
dc.contributor.authorEmwas, Abdul-Hamid Men
dc.date.accessioned2014-08-27T09:48:33Z-
dc.date.available2014-08-27T09:48:33Z-
dc.date.issued2011-10-19en
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.en
dc.identifier.issn11778881en
dc.identifier.pmid22087062en
dc.identifier.doi10.2147/DDDT.S24504en
dc.identifier.urihttp://hdl.handle.net/10754/325348en
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.en
dc.language.isoenen
dc.publisherDove Medical Press Ltd.en
dc.rights© 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.en
dc.rightsThis is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.en
dc.rightsArchived with thanks to Drug Design, Development and Therapyen
dc.subjectBioequivalence studyen
dc.subjectIbuprofenen
dc.subjectPharmacokineticsen
dc.subjectdolorazen
dc.subjectibuprofenen
dc.subjectindometacinen
dc.subjectunclassified drugen
dc.subjectabsence of side effectsen
dc.subjectaccuracyen
dc.subjectadulten
dc.subjectarea under the curveen
dc.subjectbioequivalenceen
dc.subjectblood samplingen
dc.subjectcontrolled studyen
dc.subjectcrossover procedureen
dc.subjectdrug bioavailabilityen
dc.subjectdrug blood levelen
dc.subjectdrug determinationen
dc.subjectdrug formulationen
dc.subjectdrug half lifeen
dc.subjectdrug safetyen
dc.subjectdrug stabilityen
dc.subjectdrug structureen
dc.subjectdrug tolerabilityen
dc.subjectfood and drug administrationen
dc.subjectfreeze thawingen
dc.subjecthigh performance liquid chromatographyen
dc.subjecthuman experimenten
dc.subjectintermethod comparisonen
dc.subjectnormal humanen
dc.subjectoutcome assessmenten
dc.subjectplasma concentration-time curveen
dc.subjectquality controlen
dc.subjectrandomized controlled trialen
dc.subjectsensitivity and specificityen
dc.subjectsingle drug doseen
dc.subjecttime to maximum plasma concentrationen
dc.subjectultraviolet radiationen
dc.subjectAdulten
dc.subjectArea Under Curveen
dc.subjectCalibrationen
dc.subjectCross-Over Studiesen
dc.subjectDrug Stabilityen
dc.subjectMiddle Ageden
dc.subjectReproducibility of Resultsen
dc.subjectTherapeutic Equivalencyen
dc.subjectYoung Adulten
dc.titleBioequivalence assessment of two formulations of ibuprofenen
dc.typeArticleen
dc.contributor.departmentAnalytical Core Laben
dc.identifier.journalDrug Design, Development and Therapyen
dc.identifier.pmcidPMC3210071en
dc.eprint.versionPublisher's Version/PDFen
dc.contributor.institutionCollege of Pharmacy, Al-Ain University, Al-Ain, United Arab Emiratesen
dc.contributor.institutionDepartment of Chemistry and Biochemistry, Southern Illinois University Carbondale, Carbondale, IL, United Statesen
dc.contributor.institutionDepartment of Chemistry, Jordan University of Science and Technology, Irbid, Jordanen
dc.contributor.affiliationKing Abdullah University of Science and Technology (KAUST)en
kaust.authorAl-Talla, Zeyaden
kaust.authorSioud, Salimen
kaust.authorEmwas, Abdul-Hamid M.en
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