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dc.creatorCvijić, Sandra
dc.creatorAleksić, Ivana
dc.creatorIbrić, Svetlana
dc.creatorParojčić, Jelena
dc.date.accessioned2019-09-14T21:36:40Z
dc.date.available2018-10-18
dc.date.issued2018
dc.identifier.issn1083-7450
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/3059
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/3437
dc.description.abstractConsumption of alcoholic beverages with sustained-release oral dosage forms may pose a risk to patients due to potential alcohol-induced dose dumping (ADD). Regulatory guidances recommend in vitro dissolution testing to identify the risk of ADD, but the question remains whether currently proposed test conditions can be considered biopredictive. The purpose of this study was to evaluate different dissolution setups to assess ADD, and the potential of combined in vitro-in silico approach to predict drug absorption after concomitant alcohol intake for hydrophilic and lipophilic sustained-release tablets containing ibuprofen or diclofenac sodium. According to the obtained results, the impact of ethanol was predominantly governed by the influence on matrix integrity, with the increase in drug solubility being less significant. Hydrophilic matrix tablets were less susceptible to ADD than lipophilic matrices, although the conclusion on formulation ethanol-vulnerability depended on the employed experimental conditions. In silico predictions indicated that the observed changes in drug dissolution would not result in plasma concentrations beyond therapeutic window, but sustained-release characteristics of the formulations might be lost. Overall, the study demonstrated that in vitro-in silico approach may provide insight into the effect of ADD on drug clinical performance, and serve as a tool for ADD risk assessment.en
dc.publisherTaylor & Francis Ltd, Abingdon
dc.relationinfo:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34007/RS//
dc.rightsembargoedAccess
dc.sourcePharmaceutical Development and Technology
dc.subjectAlcohol-induced dose dumpingen
dc.subjectsustained releaseen
dc.subjectdissolutionen
dc.subjectphysiologically based modelingen
dc.subjecthydrophilic matrix tabletsen
dc.subjectlipophilic matrix tabletsen
dc.titleAssessing the risk of alcohol-induced dose dumping from sustained-release oral dosage forms: in vitro-in silico approachen
dc.typearticle
dc.rights.licenseBY-NC-ND
dcterms.abstractИбрић, Светлана; Паројчић, Јелена; Цвијић, Сандра; Aлексић, Ивана;
dc.citation.volume23
dc.citation.issue9
dc.citation.spage921
dc.citation.epage932
dc.citation.other23(9): 921-932
dc.citation.rankM22
dc.description.otherThis is peer-reviewed version of the following article: Cvijić, S.; Aleksić, I.; Ibrić, S.; Parojčić, J. Assessing the Risk of Alcohol-Induced Dose Dumping from Sustained-Release Oral Dosage Forms: In Vitro–in Silico Approach. Pharm. Dev. Technol. 2018, 23 (9), 921–932. [https://doi.org/10.1080/10837450.2017.1392973]
dc.identifier.wos000449961300012
dc.identifier.doi10.1080/10837450.2017.1392973
dc.identifier.pmid29043886
dc.identifier.scopus2-s2.0-85032695179
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs/bitstream/id/7167/Assessing_the_risk_acc_2017.pdf
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dc.type.versionpublishedVersion


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