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dc.contributor.authorGarcía Villén, Fátima
dc.contributor.authorGallego Garrido, Idoia
dc.contributor.authorSainz Ramos, Myriam
dc.contributor.authorOrdoyo Pascual, Jorge
dc.contributor.authorRuiz Alonso, Sandra
dc.contributor.authorSáenz del Burgo Martínez, Laura ORCID
dc.contributor.authorO’Mahony, Conor
dc.contributor.authorPedraz Muñoz, José Luis ORCID
dc.date.accessioned2023-09-06T12:08:22Z
dc.date.available2023-09-06T12:08:22Z
dc.date.issued2023-07-30
dc.identifier.citationPharmaceutics 15(8) : (2023) // Article ID 2049es_ES
dc.identifier.issn1999-4923
dc.identifier.urihttp://hdl.handle.net/10810/62376
dc.description.abstractDrug adherence is a significant medical issue, often responsible for sub-optimal outcomes during the treatment of chronic diseases such as rheumatoid or psoriatic arthritis. Monoclonal antibodies (which are exclusively given parenterally) have been proven to be an effective treatment in these cases. The use of auto-injectors is an effective strategy to improve drug adherence in parenteral treatments since these pen-like devices offer less discomfort and increased user-friendliness over conventional syringe-based delivery. This study aims to investigate the feasibility of including a monoclonal antibody as a solid formulation inside an auto-injector pen. Specifically, the objective was to evaluate the drug stability after a concentration (to reduce the amount of solvent and space needed) and freeze-drying procedure. A preliminary screening of excipients to improve stability was also performed. The nano-DSC results showed that mannitol improved the stability of the concentrated, freeze-dried antibody in comparison to its counterpart without it. However, a small instability of the CH2 domain was still found for mannitol samples, which will warrant further investigation. The present results serve as a stepping stone towards advancing future drug delivery systems that will ultimately improve the patient experience and associated drug adherence.es_ES
dc.description.sponsorshipThis research is part of the Moore4Medical project funded by the ECSEL Joint Undertaking (grant number H2020-ECSEL-2019-IA-876190) and the Basque Country Government (Grupos consolidados IT1448-22). The participation of author S.R.-A. is supported by a Ph.D fellowship (PRE_2022_2_0144) also granted by the Basque Country Government.es_ES
dc.language.isoenges_ES
dc.publisherMDPIes_ES
dc.relationinfo:eu-repo/grantAgreement/EC/H2020/876190es_ES
dc.rightsinfo:eu-repo/semantics/openAccesses_ES
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/es/
dc.subjectmonoclonal antibodyes_ES
dc.subjectstabilityes_ES
dc.subjectnano-DSCes_ES
dc.subjectsolid formulationes_ES
dc.subjectmannitoles_ES
dc.subjectauto-injector penes_ES
dc.titleStability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Studyes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.date.updated2023-08-28T09:32:09Z
dc.rights.holder© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/ 4.0/).es_ES
dc.relation.publisherversionhttps://www.mdpi.com/1999-4923/15/8/2049es_ES
dc.identifier.doi10.3390/pharmaceutics15082049
dc.contributor.funderEuropean Commission
dc.departamentoesFarmacia y ciencias de los alimentos
dc.departamentoeuFarmazia eta elikagaien zientziak


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© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/ 4.0/).
Except where otherwise noted, this item's license is described as © 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/ 4.0/).