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Development of monoclonal antibodies in tablet form: A new approach for local delivery

Article dans une revue avec comité de lecture
Auteur
ccAUFFRAY, Julie
24480 Microbiologie Fondamentale et Pathogénicité [MFP]
1002421 Institut de Mécanique et d'Ingénierie [I2M]
ccHSEIN, Hassana
1002421 Institut de Mécanique et d'Ingénierie [I2M]
BITEAU, Nicolas
24480 Microbiologie Fondamentale et Pathogénicité [MFP]
VELOURS, Christophe
24480 Microbiologie Fondamentale et Pathogénicité [MFP]
NOËL, Thierry
24480 Microbiologie Fondamentale et Pathogénicité [MFP]
ccTCHORELOFF, Pierre
1002421 Institut de Mécanique et d'Ingénierie [I2M]

URI
http://hdl.handle.net/10985/25721
DOI
10.1016/j.ijpharm.2024.124423
Date
2024-08
Journal
International Journal of Pharmaceutics

Résumé

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.

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Documents liés

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    Development of monoclonal antibodies in tablet form: A new approach for local delivery 
    Article dans une revue avec comité de lecture
    AUFFRAY, Julie; HSEIN, Hassana; BITEAU, Nicolas; VELOURS, Christophe; NOËL, Thierry; ccTCHORELOFF, Pierre
    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 ...
  • Investigation of 3D glenohumeral displacements from 3D reconstruction using biplane X-ray images: Accuracy and reproducibility of the technique and preliminary analysis in rotator cuff tear patients 
    Article dans une revue avec comité de lecture
    ZHANG, Cheng; ccSKALLI, Wafa; LAGACÉ, Pierre-Yves; BILLUART, Fabien; OHL, Xavier; CRESSON, Thierry; BUREAU, Nathalie J.; ROULEAU, Dominique M.; ROY, André; TETREAULT, Patrice; SAURET, Christophe; DE GUISE, Jacques A.; HAGEMEISTER, Nicola (Elsevier, 2015)
    Rotator cuff (RC) tears may be associated with increased glenohumeral instability; however, this instability is difficult to quantify using currently available diagnostic tools. Recently, the three-dimensional (3D) ...
  • Investigation of 3D glenohumeral displacements from 3D reconstruction using biplane X-ray images: Accuracy and reproducibility of the technique and preliminary analysis in rotator cuff tear patients 
    Article dans une revue avec comité de lecture
    ZHANG, Cheng; ccSKALLI, Wafa; LAGACÉ, Pierre-Yves; BILLUART, Fabien; OHL, Xavier; CRESSON, Thierry; BUREAU, Nathalie J.; ROULEAU, Dominique M.; ROY, André; TÉTREAULT, Patrice; SAURET, Christophe; DE GUISE, Jacques A.; HAGEMEISTER, Nicola (Elsevier, 2016)
    Rotator cuff (RC) tears may be associated with increased glenohumeral instability; however, this instability is difficult to quantify using currently available diagnostic tools. Recently, the three-dimensional (3D) ...
  • Reevaluation of the diametral compression test for tablets using the flattened disc geometry 
    Article dans une revue avec comité de lecture
    MAZEL, Vincent; ccGUÉRARD, Sandra; CROQUELOIS, Benjamin; ccKOPP, Jean-Benoit; ccGIRARDOT, Jeremie; DIARRA, Harona; BUSIGNIES, Virginie; TCHORELOFF, Pierre (Elsevier, 2016)
    Mechanical strength is an important critical quality attribute for tablets. It is classically measured, in the pharmaceutical field, using the diametral compression test. Nevertheless, due to small contact area between the ...
  • Breaking pharmaceutical tablets with a hole: Reevaluation of the stress concentration factor and influence of the hole size 
    Article dans une revue avec comité de lecture
    CROQUELOIS, Benjamin; ccGIRARDOT, Jeremie; ccKOPP, Jean-Benoit; CAZAUTETS, Clément; TCHORELOFF, Pierre; MAZEL, Vincent (Elsevier, 2017)
    Mechanical strength is an important property for pharmaceutical tablets. Its study using the theory of linear elastic fracture mechanics has been introduced in the pharmaceutical field through the Brittle Fracture Index ...

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