The Landscape of Nanomedicines: An Expert Perspective

Article Article scientifique Revue de la littérature The Landscape of Nanomedicines: An Expert Perspective eng 2023-10-30 author Nikolic Inès 0000-0001-6534-0418 404423 Section des sciences pharmaceutiques (FARMA) author Filipic Brankica author Petrovic Marija author Jordan Olivier 0000-0003-3752-2198 133859 Section des sciences pharmaceutiques (FARMA) author Savic Snezana author Borchard Gerrit 0000-0001-6268-2586 635281 Section des sciences pharmaceutiques (FARMA) 390-403 46686 10.5937/arhfarm73-46686 0004-1963 https://aseestant.ceon.rs/index.php/arhfarm/article/view/46686/23688 The field of nanotechnology is at the forefront of a scientific revolution, where the term “nano” transcends mere size and opens the door to enormous possibilities. In the context of drug development, the selection of a suitable drug delivery system (corresponding to a certain active pharmaceutical ingredient) is a pivotal decision. Accordingly, nanosystems have emerged as a promising avenue, offering innovative solutions, and gaining recognition for addressing healthcare issues. While these products hold immense promise, they have faced certain complexities in their translation from the preclinical to the clinical setting, reflected in the lack of proper assessment protocols for quality and safety aspects and, consequently, an insufficiently defined regulatory environment. Since the groundbreaking US Food and Drug Administration (FDA) approval of liposomal doxorubicin in 1995, approximately 80 nanomedicine products have received regulatory approval so far. Recent attention has gravitated toward lipid-based nanomedicines, particularly in the development of mRNA vaccines during the COVID-19 pandemic, further highlighting their significance. However, the relatively modest number of approved nanomedicines compared to the extensive research efforts raises important questions and underscores areas of uncertainty. This article provides an overview of the challenges in defining nanomedicines, their properties, the complexities of regulatory frameworks, and the imperative for standardized characterization protocols. Nanomedicines Nanoparticles Characterization protocols Regulation of nanomedicines Dewey 615 31 Section des sciences pharmaceutiques 17 false 879 Biopharmacie Arhiv za farmaciju 73 5 1696cda8-c28c-457c-8ff6-664f98e65758 Article (Published version) Public Nikolic et al. The Landscape of Nan.pdf 229030 application/pdf CC BY-SA db46259ba756eeec4dba84831692bc1210bf44d46ac6787bea9bd766e90cb1e6 openAccess Faculté des sciences / Section des sciences pharmaceutiques

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