AUFFRAY, Julie; HSEIN, Hassana; BITEAU, Nicolas; VELOURS, Christophe; NOËL, Thierry; TCHORELOFF, Pierre

doi:10.1016/j.ijpharm.2024.124423

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AUFFRAY, Julie

Institut de Mécanique et d'Ingénierie [I2M]

HSEIN, Hassana

Institut de Mécanique et d'Ingénierie [I2M]

BITEAU, Nicolas
Microbiologie Fondamentale et Pathogénicité [MFP]

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International journal of pharmaceutics. 2024-08-15, vol. 661, p. 124423

Résumé en anglais

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.< Réduire

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Excipients

Tablets

Antibodies

Monoclonal

Drug Stability

Trehalose

Sucrose

Chemistry

Pharmaceutical

Powders

Drug Delivery Systems

Drug Compounding

Freeze Drying

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

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