Parenteral protein formulations: an overview of approved products within the European Union

dc.check.date2019-07-11
dc.check.infoAccess to this article is restricted until 12 months after publication by request of the publisher.en
dc.contributor.authorGervasi, Valeria
dc.contributor.authorDall Agnol, R.
dc.contributor.authorCullen, S.
dc.contributor.authorMcCoy, T.
dc.contributor.authorVucen, Sonja
dc.contributor.authorCrean, Abina M.
dc.contributor.funderScience Foundation Irelanden
dc.contributor.funderEnterprise Irelanden
dc.date.accessioned2018-08-14T08:21:43Z
dc.date.available2018-08-14T08:21:43Z
dc.date.issued2018-07-11
dc.date.updated2018-08-14T08:14:44Z
dc.description.abstractThe study presented is a comprehensive overview of commercial parenteral protein formulations, approved by the European Medicines Agency (EMA), 1995-2018. The objective of this overview was to analyse current trends in the design of commercial parenteral protein products and thereby support formulation scientists in the design of new formulations. The main data source was the publicly available European Public Assessment Reports (EPARs) published by the EMA for each authorised product. An analysis of the percentage of formulations in a liquid and lyophilised form was conducted. In addition, the number of products containing individual excipients, classified into functional categories is provided. Finally, the overview includes comprehensive details of product compositions obtained from EMA, US Food and Drug Administration (FDA) and product Marketing Authorisation Holder. Data analysis highlighted trends in the number of products approved, and the higher percentage of liquid parenteral protein formulations (66%) compared to lyophilised formulations (34%). This overview identifies the most commonly incorporated excipients employed as buffering agents, stabilisers/bulking agents, surfactants, preservatives and tonicifiers, including their concentration ranges of use in both liquid and lyophilised formulation approaches. Finally, antibody-based formulations were a particular focus of this overview. The relationship between parenteral routes of administration and antibody concentrations in approved products was also investigated.en
dc.description.sponsorshipEnterprise Ireland (Grant Number IP/2015 0358)en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationGervasi, V., Dall Agnol, R., Cullen, S., McCoy, T., Vucen, S. and Crean, A. (2018) 'Parenteral protein formulations: an overview of approved products within the European Union', European Journal of Pharmaceutics and Biopharmaceutics, 131, pp. 8-24. doi:10.1016/j.ejpb.2018.07.011en
dc.identifier.doi10.1016/j.ejpb.2018.07.011
dc.identifier.endpage24en
dc.identifier.issn1873-3441
dc.identifier.issn0939-6411
dc.identifier.journaltitleEuropean Journal of Pharmaceutics and Biopharmaceuticsen
dc.identifier.startpage8en
dc.identifier.urihttps://hdl.handle.net/10468/6601
dc.identifier.volume131en
dc.language.isoenen
dc.publisherElsevier B.V.en
dc.relation.projectinfo:eu-repo/grantAgreement/SFI/SFI Research Centres/12/RC/2275/IE/Synthesis and Solid State Pharmaceutical Centre (SSPC)/en
dc.rights© 2018, Elsevier B.V. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.en
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.subjectExcipientsen
dc.subjectProteinsen
dc.subjectAntibodiesen
dc.subjectFormulationen
dc.subjectLyophilisationen
dc.subjectHigh concentrationen
dc.subjectEuropean Medicines Agencyen
dc.titleParenteral protein formulations: an overview of approved products within the European Unionen
dc.typeArticle (peer-reviewed)en
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