Pain is a constant in our lives. The efficacy of drug therapy administered by the parenteral route is often limited either by the physicochemical characteristics of the drug itself or by its adsorption-distribution-metabolism-excretion (ADME) mechanisms. One promising alternative is the design of innovative drug delivery systems that can improve the pharmacokinetics |(PK) and/or reduce the toxicity of traditionally used drugs. In this review, we discuss several products that have been approved by the main regulatory agencies (i.e., nano- and microsystems, implants, and oil-based solutions), highlighting the newest technologies that govern both locally and systemically the delivery of drug compounds. Finally, we also highlight the risk assessment of the scale-up process required, given the impact that this approach could have on drug manufacturing. Teaser: The management of pain by way of the parenteral route can be improved using complex drug delivery systems (e.g., micro- and nanosystems) which require high-level assessment and shorten the regulatory pathway.

Repurposing of parentally administered active substances used to treat pain both systemically and locally / L.S. Battaglia, R. Dorati, F. Maestrelli, B. Conti, M. Gabriele, L. Di Cesare Mannelli, F. Selmin, D. Cosco. - In: DRUG DISCOVERY TODAY. - ISSN 1359-6446. - (2022), pp. 1-12. [Epub ahead of print] [10.1016/j.drudis.2022.07.006]

Repurposing of parentally administered active substances used to treat pain both systemically and locally

F. Selmin
Penultimo
;
2022

Abstract

Pain is a constant in our lives. The efficacy of drug therapy administered by the parenteral route is often limited either by the physicochemical characteristics of the drug itself or by its adsorption-distribution-metabolism-excretion (ADME) mechanisms. One promising alternative is the design of innovative drug delivery systems that can improve the pharmacokinetics |(PK) and/or reduce the toxicity of traditionally used drugs. In this review, we discuss several products that have been approved by the main regulatory agencies (i.e., nano- and microsystems, implants, and oil-based solutions), highlighting the newest technologies that govern both locally and systemically the delivery of drug compounds. Finally, we also highlight the risk assessment of the scale-up process required, given the impact that this approach could have on drug manufacturing. Teaser: The management of pain by way of the parenteral route can be improved using complex drug delivery systems (e.g., micro- and nanosystems) which require high-level assessment and shorten the regulatory pathway.
Complex drug delivery system; abridged application; extended profiling; formulation; injection; market exclusivity; risk assessment;
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
16-lug-2022
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/934846
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