The The Landscape of Nanomedicines:  An Expert Perspective

Ines Nikolić; Brankica Filipić; Marija Petrović; Olivier Jordan; Snežana Savić; Gerrit Borchard

doi:10.5937/arhfarm73-46686

Ines Nikolić University of Geneva – Faculty of Science, Section of Pharmaceutical Sciences; University of Belgrade – Faculty of Pharmacy, Department of Pharmaceutical Technology and Cosmetology
Brankica Filipić University of Belgrade – Faculty of Pharmacy, Department of Immunology and Microbiology, Belgrade
Marija Petrović University of Geneva – Faculty of Science, Section of Pharmaceutical Sciences
Olivier Jordan University of Geneva – Faculty of Science, Section of Pharmaceutical Sciences
Snežana Savić University of Belgrade – Faculty of Pharmacy, Department of Pharmaceutical Technology and Cosmetology
Gerrit Borchard University of Geneva – Faculty of Science, Section of Pharmaceutical Sciences

DOI: https://doi.org/10.5937/arhfarm73-46686

Keywords: nanomedicines, nanoparticles, characterization protocols, regulation of nanomedicines

Abstract

Polje nanotehnologije se nalazi na čelu naučne revolucije, gde se termin „nano“ izdiže iznad pukog označavanja veličine, otvarajući vrata novim mogućnostima. U kontekstu razvoja lekova, izbor odgovarajućeg sistema za isporuku / nosača (koji odgovara određenoj aktivnoj supstanci) predstavlja ključnu odluku. U tom kontekstu, nanosistemi već određeno vreme predstavljaju inovativna rešenja. Iako farmaceutski nanosistemi nose ogroman potencijal, suočavaju se sa određenim izazovima u pogledu translacije sa prekliničkog na klinički nivo, što se ogleda u nedostatku odgovarajućih protokola za ispitivanje kvaliteta i bezbednosti i, shodno tome, nedefinisanom regulatornom okruženju. Od revolucionarnog odobrenja liposomalnog doksorubicina od strane Američke agencije za hranu i lekove 1995. godine, pa sve do danas, oko 80 nano formulacija (nanolekova) odobreno je za kliničku primenu. Odnedavno je intenzivnija pažnja usmerena ka nanoformulacijama baziranim na lipidima, što je delom posledica razvoja mRNK vakcina tokom pandemije COVID-19. Međutim, relativno skroman nastup nanolekova na tržištu (u poređenju sa obimnim istraživačkim naporima i finansijskim ulaganjima u ovu oblast) otvara važna pitanja. Ovaj rad pruža pregled izazova u definisanju nanolekova, njihovih svojstava, kompleksnosti regulatornih okvira i imperativa za stvaranje standardizovanih protokola karakterizacije.

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