Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary

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dc.contributor.authorReppas, Christos
dc.contributor.authorKuentz, Martin
dc.contributor.authorBauer-Brandl, Annette
dc.contributor.authorCarlert, Sara
dc.contributor.authorDallmann, André
dc.contributor.authorDietrich, Shirin
dc.contributor.authorDressman, Jennifer
dc.contributor.authorEjskjaer, Lotte
dc.contributor.authorFrechen, Sebastian
dc.contributor.authorGuidetti, Matteo
dc.contributor.authorHolm, René
dc.contributor.authorHolzem, Florentin Lukas
dc.contributor.authorKarlsson, Εva
dc.contributor.authorKostewicz, Edmund
dc.contributor.authorPanbachi, Shaida
dc.contributor.authorPaulus, Felix
dc.contributor.authorSenniksen, Malte Bøgh
dc.contributor.authorStillhart, Cordula
dc.contributor.authorTurner, David B.
dc.contributor.authorVertzoni, Maria
dc.contributor.authorVrenken, Paul
dc.contributor.authorZöller, Laurin
dc.contributor.authorGriffin, Brendan T.
dc.contributor.authorO'Dwyer, Patrick J.
dc.contributor.funderHorizon 2020
dc.date.accessioned2023-09-29T13:41:20Z
dc.date.available2023-09-28T16:40:08Zen
dc.date.available2023-09-29T13:41:20Z
dc.date.issued2023-07-13
dc.date.updated2023-09-28T15:40:11Zen
dc.description.abstractDue to the strong tendency towards poorly soluble drugs in modern development pipelines, enabling drug formulations such as amorphous solid dispersions, cyclodextrins, co-crystals and lipid-based formulations are frequently applied to solubilize or generate supersaturation in gastrointestinal fluids, thus enhancing oral drug absorption. Although many innovative in vitro and in silico tools have been introduced in recent years to aid development of enabling formulations, significant knowledge gaps still exist with respect to how best to implement them. As a result, the development strategy for enabling formulations varies considerably within the industry and many elements of empiricism remain. The InPharma network aims to advance a mechanistic, animal-free approach to the assessment of drug developability. This commentary focuses current status and next steps that will be taken in InPharma to identify and fully utilize 'best practice' in vitro and in silico tools for use in physiologically based biopharmaceutic models.en
dc.description.statusPeer revieweden
dc.description.versionPublished Version
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid106505
dc.identifier.citationReppas, C., Kuentz, M., Bauer-Brandl, A., Carlert, S., Dallmann, A., Dietrich, S., Dressman, J., Ejskjaer, L., Frechen, S., Guidetti, M., Holm, R., Holzem, F. L., Karlsson, E., Kostewicz, E., Panbachi, S., Paulus, F., Senniksen, M. B., Stillhart, C., Turner, D. B., Vertzoni, M., Vrenken, P., Zöller, L., Griffin, B. T. and O'Dwyer, P. J. (2023) 'Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary', European Journal of Pharmaceutical Sciences, 188, 106505 (22pp). doi: 10.1016/j.ejps.2023.106505
dc.identifier.doi10.1016/j.ejps.2023.106505en
dc.identifier.endpage22
dc.identifier.issn0928-0987
dc.identifier.journaltitleEuropean Journal of Pharmaceutical Sciences
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/15056
dc.identifier.volume188
dc.language.isoenen
dc.publisherElsevier B.V.
dc.relation.projectinfo:eu-repo/grantAgreement/EC/H2020::MSCA-ITN-EID/955756/EU/A fully integrated, animal-free, end-to-end modelling approach to oral drug product development/InPharma
dc.rights© 2023, the Authors. Published by Elsevier B.V. This is an open access article under the CC BY license.
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectEnabling formulations In vitroIn silico
dc.subjectPBBMrDCS
dc.subjectComputational
dc.subjectAmorphous solid dispersions
dc.subjectLipid-based formulations
dc.subjectCyclodextrins
dc.subjectCo-crystals
dc.subjectSalts
dc.titleLeveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary
dc.typeArticle (peer-reviewed)
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