Stability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Study
dc.contributor.author | García Villén, Fátima | |
dc.contributor.author | Gallego Garrido, Idoia | |
dc.contributor.author | Sainz Ramos, Myriam | |
dc.contributor.author | Ordoyo Pascual, Jorge | |
dc.contributor.author | Ruiz Alonso, Sandra | |
dc.contributor.author | Sáenz del Burgo Martínez, Laura | |
dc.contributor.author | O’Mahony, Conor | |
dc.contributor.author | Pedraz Muñoz, José Luis | |
dc.date.accessioned | 2023-09-06T12:08:22Z | |
dc.date.available | 2023-09-06T12:08:22Z | |
dc.date.issued | 2023-07-30 | |
dc.identifier.citation | Pharmaceutics 15(8) : (2023) // Article ID 2049 | es_ES |
dc.identifier.issn | 1999-4923 | |
dc.identifier.uri | http://hdl.handle.net/10810/62376 | |
dc.description.abstract | Drug 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.sponsorship | This 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.iso | eng | es_ES |
dc.publisher | MDPI | es_ES |
dc.relation | info:eu-repo/grantAgreement/EC/H2020/876190 | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/es/ | |
dc.subject | monoclonal antibody | es_ES |
dc.subject | stability | es_ES |
dc.subject | nano-DSC | es_ES |
dc.subject | solid formulation | es_ES |
dc.subject | mannitol | es_ES |
dc.subject | auto-injector pen | es_ES |
dc.title | Stability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Study | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.date.updated | 2023-08-28T09:32:09Z | |
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.publisherversion | https://www.mdpi.com/1999-4923/15/8/2049 | es_ES |
dc.identifier.doi | 10.3390/pharmaceutics15082049 | |
dc.contributor.funder | European Commission | |
dc.departamentoes | Farmacia y ciencias de los alimentos | |
dc.departamentoeu | Farmazia eta elikagaien zientziak |
Files in this item
This item appears in the following Collection(s)
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/).