• Login
    View Item 
    •   Home
    • Research
    • Articles
    • View Item
    •   Home
    • Research
    • Articles
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of KAUSTCommunitiesIssue DateSubmit DateThis CollectionIssue DateSubmit Date

    My Account

    Login

    Quick Links

    Open Access PolicyORCID LibguideTheses and Dissertations LibguideSubmit an Item

    Statistics

    Display statistics

    Bioequivalence assessment of two formulations of ibuprofen

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    Article-Drug_Desig-Bioequival-2011.pdf
    Size:
    211.9Kb
    Format:
    PDF
    Description:
    Article - Full Text
    Download
    Type
    Article
    Authors
    Al-Talla, Zeyad
    Akrawi, Sabah H
    Tolley, Luke T
    Sioud, Salim
    Zaater, Mohammed F
    Emwas, Abdul-Hamid M.
    KAUST Department
    Analytical Chemistry Core Lab
    Imaging and Characterization Core Lab
    Date
    2011-10
    Permanent link to this record
    http://hdl.handle.net/10754/325348
    
    Metadata
    Show full item record
    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.
    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
    Informa UK Limited
    Journal
    Drug Design, Development and Therapy
    DOI
    10.2147/DDDT.S24504
    PubMed ID
    22087062
    PubMed Central ID
    PMC3210071
    ae974a485f413a2113503eed53cd6c53
    10.2147/DDDT.S24504
    Scopus Count
    Collections
    Articles; Analytical Chemistry Core Lab; Imaging and Characterization Core Lab

    entitlement

    Related articles

    • Pharmacokinetic and bioequivalence studies of ibuprofen suspension after a single-dose administration in healthy Chinese volunteers.
    • Authors: Song H, Zhang R, Wei C, Yuan G, Liu X, Li R, Wang B, Guo R
    • Issue date: 2013 Aug
    • Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
    • Authors: Atkinson HC, Stanescu I, Frampton C, Salem II, Beasley CP, Robson R
    • Issue date: 2015 Oct
    • Comparative bioavailability of two tablet formulations of ibuprofen.
    • Authors: el-Sayed YM, Gouda MW, al-Khamis KI, al-Meshal MA, al-Dhawailie AA, al-Rayes S, Bin-Salih SA, al-Rashood KA
    • Issue date: 1995 May
    • A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.
    • Authors: Elshafeey AH, Elsherbiny MA, Fathallah MM
    • Issue date: 2009 Mar
    • Comparative bioavailability of three ibuprofen formulations in healthy human volunteers.
    • Authors: Mendes GD, Mendes FD, Domingues CC, Oliveira RA, da Silva MA, Chen LS, Ilha JO, Fernandes CE, Nucci GD
    • Issue date: 2008 Jun
    DSpace software copyright © 2002-2023  DuraSpace
    Quick Guide | Contact Us | KAUST University Library
    Open Repository is a service hosted by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items. For anonymous users the allowed maximum amount is 50 search results.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.