Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

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dc.contributor.authorBojňanská, Erikacs
dc.contributor.authorKalina, Michalcs
dc.contributor.authorPařízek, Ladislavcs
dc.contributor.authorBartoníčková, Evacs
dc.contributor.authorOpravil, Tomášcs
dc.contributor.authorVeselý, Michalcs
dc.contributor.authorPekař, Miloslavcs
dc.contributor.authorJampílek, Josefcs
dc.coverage.issue1cs
dc.coverage.volume2014cs
dc.date.issued2014-09-15cs
dc.description.abstractThe purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers.The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.en
dc.description.abstractThe purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers.The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.en
dc.formattextcs
dc.format.extent1-9cs
dc.format.mimetypeapplication/pdfcs
dc.identifier.citationJOURNAL OF BIOMEDICINE AND BIOTECHNOLOGY. 2014, vol. 2014, issue 1, p. 1-9.en
dc.identifier.doi10.1155/2014/929248cs
dc.identifier.issn1110-7243cs
dc.identifier.orcid0000-0002-4224-0841cs
dc.identifier.orcid0000-0002-5866-7946cs
dc.identifier.orcid0000-0003-3851-3939cs
dc.identifier.orcid0000-0001-5365-3134cs
dc.identifier.orcid0000-0002-3878-0917cs
dc.identifier.other109417cs
dc.identifier.scopus7006307069cs
dc.identifier.scopus25621179000cs
dc.identifier.urihttp://hdl.handle.net/11012/84159
dc.language.isoencs
dc.publisherHindawi Publishing Corporationcs
dc.relation.ispartofJOURNAL OF BIOMEDICINE AND BIOTECHNOLOGYcs
dc.relation.urihttp://dx.doi.org/10.1155/2014/929248cs
dc.rightsCreative Commons Attribution 3.0 Unportedcs
dc.rights.accessopenAccesscs
dc.rights.sherpahttp://www.sherpa.ac.uk/romeo/issn/1110-7243/cs
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/cs
dc.subjectCritical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testingen
dc.subjectZeta potentialen
dc.subjectParticle size distributionen
dc.subjectSpecific surface areaen
dc.subjectScanning electron microscopyen
dc.subjectCritical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testing
dc.subjectZeta potential
dc.subjectParticle size distribution
dc.subjectSpecific surface area
dc.subjectScanning electron microscopy
dc.titleDetermination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Studyen
dc.title.alternativeDetermination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Studyen
dc.type.driverarticleen
dc.type.statusPeer-revieweden
dc.type.versionpublishedVersionen
sync.item.dbidVAV-109417en
sync.item.dbtypeVAVen
sync.item.insts2025.10.14 14:06:26en
sync.item.modts2025.10.14 09:55:22en
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. Ústav fyzikální a spotřební chemiecs
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. CMV - laboratoř anorganických materiálůcs
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. CMV - laboratoř kovů a korozecs
thesis.grantorVysoké učení technické v Brně. Fakulta chemická. CMV - laboratoř biokoloidůcs
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