QbD application for a fixed-dose combination with biowaiver potential: Evaluations of In vitro and In vivo applications

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dc.authorid0000-0001-9549-8857en_US
dc.authorid0000-0001-5591-7607en_US
dc.contributor.authorYaşın, Diren Sarısaltık
dc.contributor.authorUslu, Abdullah
dc.contributor.authorUyar, Emre
dc.contributor.authorErdinç, Meral
dc.contributor.authorTeksin, Zeynep Şafak
dc.date.accessioned2023-03-21T11:55:48Z
dc.date.available2023-03-21T11:55:48Z
dc.date.issued2022en_US
dc.departmentDicle Üniversitesi, Eczacılık Fakültesi, Eczacılık Teknolojisi Bölümüen_US
dc.description.abstractPurpose The purpose of this study was to use the quality by design (QbD) approach to design a directly compressed fixed-dose combination (FDC) tablet comprising amlodipine besylate and enalapril maleate with biowaiver potential in alignment with the Biopharmaceutical Classification System (BCS). Methods As a result of the risk assessment, the amounts of the formulation components such as disintegrant, binder, and lubricant were selected as critical material attributes, and the processes of blending and lubrication were accepted as critical process parameters in a screening design of Plackett-Burman. These factors were evaluated based on the statistical significance of their impact on the drug product's content uniformity, assay, friability, disintegration, and dissolution. The most significant factors determined with the use of Pareto charts and half-normal graphs were the amount of lubricant and disintegrant and blending time, all of which were subsequently optimized using Box-Behnken Design. The optimum formulation was evaluated with in vitro quality tests and in vivo blood pressure-lowering efficacy tests, the results of which were compared to the individual references in rats. Results As a result of the optimization process, a design space was established for the critical factors. FDC product showed quality and dissolution profiles similar to those of the references. Combination therapy was superior to individual drugs in rats (p < 0.05). Conclusion It was concluded that an FDC product eligible for BCS-based biowaiver can be developed systematically by using the QbD concept. It was demonstrated that using scanning designs prior to optimization can reduce the number of unnecessary experiments and yield more reliable results in less time.en_US
dc.identifier.citationYaşın, D.S., Uslu, A., Uyar, E., Erdinç, M. ve Teksin, Z.Ş. (2022). QbD application for a fixed-dose combination with biowaiver potential: Evaluations of In vitro and In vivo applications. Journal of Pharmaceutical Innovation, Early Accessen_US
dc.identifier.doi10.1007/s12247-022-09633-1
dc.identifier.issn1872-5120
dc.identifier.issn1939-8042
dc.identifier.scopus2-s2.0-85126733309
dc.identifier.scopusqualityQ2
dc.identifier.urihttps://link.springer.com/article/10.1007/s12247-022-09633-1
dc.identifier.urihttps://hdl.handle.net/11468/11472
dc.identifier.volumeEarly Accessen_US
dc.identifier.wosWOS:000771543800001
dc.identifier.wosqualityQ3
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.institutionauthorYaşın, Diren Sarısaltık
dc.institutionauthorErdinç, Meral
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.relation.ispartofJournal of Pharmaceutical Innovation
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectFixed-dose combinationen_US
dc.subjectQuality by designen_US
dc.subjectDesign of experimentsen_US
dc.subjectBiowaiveren_US
dc.subjectAmlodipineen_US
dc.subjectEnalaprilen_US
dc.titleQbD application for a fixed-dose combination with biowaiver potential: Evaluations of In vitro and In vivo applicationsen_US
dc.titleQbD application for a fixed-dose combination with biowaiver potential: Evaluations of In vitro and In vivo applications
dc.typeArticleen_US

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