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dc.creatorHomšek, Irena
dc.creatorParojčić, Jelena
dc.creatorCvetković, Nebojša
dc.creatorPopadić, Dragica
dc.creatorĐurić, Zorica
dc.date.accessioned2019-09-02T11:09:58Z
dc.date.available2019-09-02T11:09:58Z
dc.date.issued2007
dc.identifier.issn0004-4172
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/938
dc.description.abstractA growing concern for the biopharmaceutical characterization of pharmaceutical products increased the interest in the evaluation and identification of physicochemical properties of drugs and dosage forms that govern its biological performance. In vitro and in vivo characteristics of two carbamazepine (CAS 298-46-4) immediate release tablets were investigated and compared in order to establish level A in vitro-in vivo correlation. An in vivo study was conducted as a controlled, two-way, complete cross-over, single dose, pharmacokinetic trial in 18 subjects. The in vitro study was performed using various dissolution media in order to evaluate their potential influence on drug release and distinguish the set of experimental conditions relevant to the in vivo behavior of the investigated drug products. Beside significant differences among in vitro release profiles, the in vivo data indicated bioequivalence of the two formulations. Although a high level of correlation between in vivo and in vitro data was observed in some media, there was no single in vitro-in vivo correlation model applicable products. The obtained results add to the existing debate on the rationale for the use of surfactants in drug release media and their in vivo relevance, emphasizing the importance of in vitro dissolution testing in addition to in vivo bioequivalence testing.en
dc.publisherECV-Editio Cantor Verlag Medizin Naturwissenschaften, Aulendorf
dc.rightsrestrictedAccess
dc.sourceArzneimittelforschung - Drug Research
dc.subjectantiepilepticsen
dc.subjectcarbamazepineen
dc.subjectCAS 298-46-4en
dc.subjectkarbamazepin (R) tabletsen
dc.subjectdissolutionen
dc.subjectimmediate release tableten
dc.subjectin vitro-in vivo correlationen
dc.titleBiopharmaceutical characterization of carbamazepine immediate release tablets - In vitro-in vivo comparisonen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractЦветковић, Небојша; Паројчић, Јелена; Попадић, Драгица; Ђурић, Зорица; Хомшек, Ирена;
dc.citation.volume57
dc.citation.issue8
dc.citation.spage511
dc.citation.epage516
dc.citation.other57(8): 511-516
dc.citation.rankM23
dc.identifier.wos000249756500001
dc.identifier.pmid17915636
dc.identifier.scopus2-s2.0-34548786342
dc.identifier.rcubconv_1753
dc.type.versionpublishedVersion


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