The ,,Pejzažni” prikaz nanolekova: ekspertska perspektiva

  • Ines Nikolić Univerzitet u Ženevi – Fakultet prirodnih nauka, Odsek za farmaceutske nauke; Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju
  • Brankica Filipić Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za imunologiju i mikrobiologiju
  • Marija Petrović Univerzitet u Ženevi – Fakultet prirodnih nauka, Odsek za farmaceutske nauke
  • Olivier Jordan Univerzitet u Ženevi – Fakultet prirodnih nauka, Odsek za farmaceutske nauke
  • Snežana Savić Univerzitet u Beogradu – Farmaceutski fakultet, Katedra za farmaceutsku tehnologiju i kozmetologiju
  • Gerrit Borchard Univerzitet u Ženevi – Fakultet prirodnih nauka, Odsek za farmaceutske nauke
DOI: https://doi.org/10.5937/arhfarm73-46686
Ključne reči: nanolekovi, nanočestice, protokoli za karakterizaciju, regulatorni aspekti nanolekova

Sažetak


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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Objavljeno
2023/10/27
Broj časopisa
Vol. 73 Br. Notebook 5 (2023): Arhiv za farmaciju
Rubrika
Pregledni (Revijalni) rad
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