Structural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitution

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dc.contributor.authorMuselík, Jancs
dc.contributor.authorUrbanová, Martinacs
dc.contributor.authorBartoníčková, Evacs
dc.contributor.authorPalovčík, Jakubcs
dc.contributor.authorVetchý, Davidcs
dc.contributor.authorCzernek, Jiřícs
dc.contributor.authorJanišová, Larisacs
dc.contributor.authorVelychkivska, Nadiiacs
dc.contributor.authorFranc, Alešcs
dc.contributor.authorBrus, Jiřícs
dc.coverage.issue9cs
dc.coverage.volume13cs
dc.date.accessioned2021-09-22T14:57:27Z
dc.date.available2021-09-22T14:57:27Z
dc.date.issued2021-08-30cs
dc.description.abstractAt present, the risk of generic substitutions in warfarin tablets is still being discussed. The aim of this study was to assess whether API interactions with commonly used excipients may affect the safety of generic replacement of warfarin sodium tablets. These interactions were observed during an accelerated stability study, and the effect of the warfarin solid phase (crystalline/amorphous form) as well as the API particle size distribution was studied. Commercial tablets and prepared tablets containing crystalline warfarin or amorphous warfarin were used. In addition, binary mixtures of warfarin with various excipients were prepared. The structural changes before and after the stability study were monitored by dissolution test in different media, solid-state NMR spectroscopy and Raman microscopy. During the stability study, the conversion of the sodium in warfarin to its acid form was demonstrated by some excipients (e.g., calcium phosphate). This change in the solid phase of warfarin leads to significant changes in dissolution, especially with the different particle sizes of the APIs in the tablet. Thus, the choice of suitable excipients and particle sizes are critical factors influencing the safety of generic warfarin sodium tablets.en
dc.formattextcs
dc.format.extent1-19cs
dc.format.mimetypeapplication/pdfcs
dc.identifier.citationPharmaceutics. 2021, vol. 13, issue 9, p. 1-19.en
dc.identifier.doi10.3390/pharmaceutics13091364cs
dc.identifier.issn1999-4923cs
dc.identifier.other172524cs
dc.identifier.urihttp://hdl.handle.net/11012/201638
dc.language.isoencs
dc.publisherMDPIcs
dc.relation.ispartofPharmaceuticscs
dc.relation.urihttps://www.mdpi.com/1999-4923/13/9/1364cs
dc.rightsCreative Commons Attribution 4.0 Internationalcs
dc.rights.accessopenAccesscs
dc.rights.sherpahttp://www.sherpa.ac.uk/romeo/issn/1999-4923/cs
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/cs
dc.subjectwarfarinen
dc.subjectsolid-state NMRen
dc.subjectpolymorphismen
dc.subjectstabilityen
dc.subjectparticle sizeen
dc.subjectbioavailabilityen
dc.subjectgeneric substitutionen
dc.titleStructural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitutionen
dc.type.driverarticleen
dc.type.statusPeer-revieweden
dc.type.versionpublishedVersionen
sync.item.dbidVAV-172524en
sync.item.dbtypeVAVen
sync.item.insts2022.03.11 12:53:31en
sync.item.modts2022.03.11 12:14:01en
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. Ústav chemie materiálůcs
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. Centrum materiálového výzkumucs
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