Development of monoclonal antibodies in tablet form: A new approach for local delivery.
| dc.rights.license | open | en_US |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | AUFFRAY, Julie
IDREF: 256072906 | |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | HSEIN, Hassana | |
| hal.structure.identifier | Microbiologie Fondamentale et Pathogénicité [MFP] | |
| dc.contributor.author | BITEAU, Nicolas | |
| hal.structure.identifier | Microbiologie Fondamentale et Pathogénicité [MFP] | |
| dc.contributor.author | VELOURS, Christophe | |
| hal.structure.identifier | Microbiologie Fondamentale et Pathogénicité [MFP] | |
| dc.contributor.author | NOËL, Thierry | |
| hal.structure.identifier | Institut de Mécanique et d'Ingénierie [I2M] | |
| dc.contributor.author | TCHORELOFF, Pierre
IDREF: 069233624 | |
| dc.date.accessioned | 2024-10-01T06:48:06Z | |
| dc.date.available | 2024-10-01T06:48:06Z | |
| dc.date.issued | 2024-08-15 | |
| dc.identifier.issn | 1873-3476 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/202077 | |
| dc.description.abstractEn | Among the various pharmaceutical forms, tablets offer numerous advantages, like ease of administration, cost-effectiveness in production, and better stability of biomolecules. Beyond these benefits, the tablet form opens up possibilities for alternative routes for the local delivery of biopharmaceuticals such as oral or vaginal administration, thereby expanding the therapeutic applications of these biomolecules and overcoming the inconvenients associated with parenteral administration. However, to date there is limited information on the feasibility of developing biomolecules in the tablet form. In this study, we have evaluated the feasibility of developing monoclonal antibodies in the tablet form while preserving their biological properties. Different excipients and process parameters were studied to assess their impact on the antibody's integrity during tableting. ELISA results show that applying compression pressure up to 100 MPa is not detrimental to the antibody's binding properties when formulated from a lyophilized powder containing trehalose or sucrose as the major excipient. This observation was confirmed with SPR and ultracentrifugation experiments, which demonstrated that neither the binding affinity for both Fc and Fab antibody fragments nor its aggregation rate are affected by the tableting process. After compression, the tablets containing the antibodies have been shown to be stable for 6 months at room temperature. | |
| dc.language.iso | EN | en_US |
| dc.subject.en | Excipients | |
| dc.subject.en | Tablets | |
| dc.subject.en | Antibodies | |
| dc.subject.en | Monoclonal | |
| dc.subject.en | Drug Stability | |
| dc.subject.en | Trehalose | |
| dc.subject.en | Sucrose | |
| dc.subject.en | Chemistry | |
| dc.subject.en | Pharmaceutical | |
| dc.subject.en | Powders | |
| dc.subject.en | Drug Delivery Systems | |
| dc.subject.en | Drug Compounding | |
| dc.subject.en | Freeze Drying | |
| dc.title.en | Development of monoclonal antibodies in tablet form: A new approach for local delivery. | |
| dc.title.alternative | Int J Pharm | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1016/j.ijpharm.2024.124423 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Microbiologie et Parasitologie | en_US |
| dc.identifier.pubmed | 38971511 | en_US |
| bordeaux.journal | International journal of pharmaceutics | en_US |
| bordeaux.page | 124423 | en_US |
| bordeaux.volume | 661 | en_US |
| bordeaux.hal.laboratories | MFP (Laboratoire Microbiologie Fondamentale et Pathogénicité) - UMR 5234 | en_US |
| bordeaux.institution | CNRS | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| bordeaux.import.source | pubmed | |
| hal.identifier | hal-04715654 | |
| hal.version | 1 | |
| hal.date.transferred | 2024-10-01T06:48:08Z | |
| hal.popular | non | en_US |
| hal.audience | Internationale | en_US |
| hal.export | true | |
| workflow.import.source | pubmed | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=International%20journal%20of%20pharmaceutics&rft.date=2024-08-15&rft.volume=661&rft.spage=124423&rft.epage=124423&rft.eissn=1873-3476&rft.issn=1873-3476&rft.au=AUFFRAY,%20Julie&HSEIN,%20Hassana&BITEAU,%20Nicolas&VELOURS,%20Christophe&NO%C3%8BL,%20Thierry&rft.genre=article |
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