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dc.rights.licenseopenen_US
dc.contributor.authorYOST, Edward
hal.structure.identifierInstitut de Mécanique et d'Ingénierie [I2M]
dc.contributor.authorMAZEL, Vincent
IDREF: 113057954
dc.contributor.authorSLUGA, Kellie
dc.contributor.authorNAGAPUDI, Karthik
dc.contributor.authorMULIADI, Ariel R
dc.date.accessioned2022-03-30T15:16:36Z
dc.date.available2022-03-30T15:16:36Z
dc.date.issued2022-01
dc.identifier.issn1520-6017en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/136574
dc.description.abstractEnActive pharmaceutical ingredients (API) and excipients are often classified as 'brittle' or 'ductile' based on their yield pressure determined through the Heckel analysis. Such a brittle/ductile classification is often correlated to some measure of elasticity, die-wall stresses, and brittle fracture propensities from studies performed with a handful of model excipients. This subsequently gives rise to the presumption that all ductile materials behave similarly to microcrystalline cellulose (MCC) and that all brittle materials to lactose, mannitol, or dicalcium phosphate. Such a 'one-size-fits-all' approach can subsequently lead to inaccurate classification of APIs, which often behave very differently than these model excipients. This study compares the commonly reported mechanical metrics of two proprietary APIs and two classical model excipients. We demonstrate that materials classified as 'ductile' by Heckel's 'standards' may behave very differently than MCC and in some cases may even have a propensity for brittle failure. Our data highlight the complexity of APIs and the need to evaluate a set of mechanical metrics, instead of binary assignments of ductility or brittleness based on quantities that do not fully capture the tableting process, to truly optimize a tablet formulation as part of the overall target product profile.
dc.language.isoENen_US
dc.subject.enCompaction
dc.subject.enCompression
dc.subject.enCrushing strength
dc.subject.enFormulation
dc.subject.enHardness
dc.subject.enMaterials science
dc.subject.enMechanical properties
dc.subject.enSolid dosage form(s)
dc.subject.enTablet(s)
dc.subject.enTableting
dc.title.enBeyond Brittle/Ductile Classification: Applying Proper Constitutive Mechanical Metrics to Understand the Compression Characteristics of Pharmaceutical Materials.
dc.title.alternativeJ Pharm Scien_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.xphs.2022.01.004en_US
dc.subject.halSciences de l'ingénieur [physics]/Autreen_US
dc.identifier.pubmed35007567en_US
bordeaux.journalJournal of Pharmaceutical Sciencesen_US
bordeaux.hal.laboratoriesInstitut de Mécanique et d’Ingénierie de Bordeaux (I2M) - UMR 5295en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionBordeaux INPen_US
bordeaux.institutionCNRSen_US
bordeaux.institutionINRAEen_US
bordeaux.institutionArts et Métiersen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcepubmed
hal.identifierhal-03625234
hal.version1
hal.date.transferred2022-03-30T15:16:38Z
hal.exporttrue
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Journal%20of%20Pharmaceutical%20Sciences&rft.date=2022-01&rft.eissn=1520-6017&rft.issn=1520-6017&rft.au=YOST,%20Edward&MAZEL,%20Vincent&SLUGA,%20Kellie&NAGAPUDI,%20Karthik&MULIADI,%20Ariel%20R&rft.genre=article


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