In the context of subcutaneous administration, one of the main obstacles is related to the limited volume that can be administered without causing pain, immunogenicity, and injectability issues. To meet patient-specific needs, administering a highly concentrated drug within a relatively small volume poses several challenges. Recently, on-body drug delivery systems (OBDSs) have emerged as a way to overcome existing limitations in drug delivery, as they can enable the delivery of doses exceeding 2 ml at precisely controlled rates and durations. This article examines recently developed and/or authorized OBDSs, classified as either medical devices or medicinal products; provides an overview of biopharmaceutical requirements and patient compliance; and highlights market concerns and economic sustainability.

On-body drug delivery systems: State-of-the-art technologies, clinical application, and future perspectives / R. Dorati, D. Cosco, L. Battaglia, M. Cirri, B. Conti, T. Borghi, M. Gabriele, G.M. Bruno, P. Rocco, F. Selmin, F. Maestrelli. - In: DRUG DISCOVERY TODAY. - ISSN 1878-5832. - (2025), pp. 104441.1-104441.36. [Epub ahead of print] [10.1016/j.drudis.2025.104441]

On-body drug delivery systems: State-of-the-art technologies, clinical application, and future perspectives

P. Rocco;F. Selmin
Penultimo
;
2025

Abstract

In the context of subcutaneous administration, one of the main obstacles is related to the limited volume that can be administered without causing pain, immunogenicity, and injectability issues. To meet patient-specific needs, administering a highly concentrated drug within a relatively small volume poses several challenges. Recently, on-body drug delivery systems (OBDSs) have emerged as a way to overcome existing limitations in drug delivery, as they can enable the delivery of doses exceeding 2 ml at precisely controlled rates and durations. This article examines recently developed and/or authorized OBDSs, classified as either medical devices or medicinal products; provides an overview of biopharmaceutical requirements and patient compliance; and highlights market concerns and economic sustainability.
biotechnological drugs; economic sustainability; large-volume injection; packaging; patient-centric delivery devices; subcutaneous injections;
Settore CHEM-08/A - Tecnologia, socioeconomia e normativa dei medicinali e dei prodotti per il benessere e per la salute
2025
29-lug-2025
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1178295
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