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In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver

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dc.contributor.author Kyriacos, Soula Boustani
dc.contributor.author Boukarim, Chawki
dc.contributor.author Safi, William
dc.contributor.author Mroueh, Mohamad
dc.contributor.author Maroun, Aline Bou
dc.contributor.author El-Khoury, Ghada
dc.contributor.author Shehayeb, Rabih
dc.date.accessioned 2015-11-25T10:49:57Z
dc.date.available 2015-11-25T10:49:57Z
dc.date.copyright 2009
dc.date.issued 2015-11-25
dc.identifier.issn 1021-9498 en_US
dc.identifier.uri http://hdl.handle.net/10725/2688
dc.description.abstract The purpose of this study was to compare the technical quality of ciprofloxacin tablets and examine the feasibility of biopharmaceutical classification system (BCS) biowaiver. Ciprofloxacin is a synthetic quinolone derivative anti-infective agent that has been classified as a Class 3 substance according to the biopharmaceutics classification system. Due to the importance of ciprofloxacin as an antibiotic for widely resistant bacteria and the importance of price in a community basis, different ciprofloxacin products available on the market were analyzed. The possibility of extending biowaivers to ciprofloxacin was also examined. Waiver for Class 2 and Class 3 drugs is sometimes scientifically justified. Ciprofloxacin has properties that are intermediate between BCS Classes 2 and 3, as the drug is highly soluble below pH 6 and poorly soluble above this pH. Ten generic brands and the innovator brand were compared on friability, hardness, average weight, content uniformity, disintegration and dissolution. In vitro testing indicates significant variations among some brands in terms of hardness, disintegration and dissolution. Dissolution testing met pharmacopeial requirements for all brands. However, significant variations in dissolution profiles were observed in 0.1N HCl and in phosphate buffer (pH 6.8) with no difference detected in acetate buffer (pH 4.5). The results suggest that the formulation and/or the manufacturing process affect the dissolution and thus the bioavailability of the drug products. The significance of the observed in vitro differences must be confirmed by an in vivo bioequivalence study. en_US
dc.language.iso en en_US
dc.title In Vitro Testing of Ciprofloxacin Formulations and Preliminary Study on BCS Biowaiver en_US
dc.type Article en_US
dc.description.version Published en_US
dc.author.school SOP en_US
dc.author.idnumber 199590020 en_US
dc.author.idnumber 200104046
dc.author.woa N/A en_US
dc.author.department Pharmaceutical Sciences Department en_US
dc.description.embargo N/A en_US
dc.relation.journal Journal of Food and Drug Analysis en_US
dc.journal.volume 17 en_US
dc.journal.issue 2 en_US
dc.article.pages 78-84 en_US
dc.keywords Ciprofloxacin en_US
dc.keywords Quality control en_US
dc.keywords Biopharmaceutical classification system en_US
dc.keywords Biowaiver en_US
dc.identifier.ctation Kyriacos, S. B., Boukarim, C., Safi, W., Mroueh, M., Maroun, A. B., El-Khoury, G., & Shehayeb, R. (2009). In vitro testing of ciprofloxacin formulations and preliminary study on BCS biowaiver. Journal of food and drug analysis, 17(2). en_US
dc.author.email mmroueh@lau.edu.lb
dc.author.email ghada.khoury@lau.edu.lb
dc.identifier.url https://www.researchgate.net/profile/Mohamad_Mroueh/publication/265937614_In_Vitro_Testing_of_Ciprofloxacin_Formulations_and_Preliminary_Study_on_BCS_Biowaiver/links/54f99ff60cf210398e9913d9/In-Vitro-Testing-of-Ciprofloxacin-Formulations-and-Preliminary-Study-on-BCS-Biowaiver.pdf
dc.orcid.id https://orcid.org/0000-0003-1572-7133 en_US
dc.orcid.id https://orcid.org/0000-0002-7642-4833 en_US


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