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The Emergent Potential of Nanoscale Drug Delivery Systems Loaded with Natural Products: Innovation Between Challenges and Regulatory Frameworks

Bilia AR, Grifoni L, Tomou E, Bussotti R, Vanti G

2026

Abstract

This review reports on the huge potential of natural products (NPs) as drugs due to their pleiotropic activities and discusses the recent research and development of nanoscale drug delivery systems loaded with NPs. Indeed, the number of publications is dramatically increased in the last years and excellent biopharmaceutical properties of nanosized vectors loaded with NPs have been reported, however on the market the number of products based on nanoscale drug delivery systems are limited essentially to food supplements and cosmetics. The difficulties of NPs loaded nanovectors to reach the market as medicine is mainly due to the lack of dedicated regulatory frameworks, a specialized "nano" legal context. Instead, nanovectors are evaluated on a case-by-case basis under existing broad pharmaceutical regulations under traditional benefit/risk frameworks. This manuscript would be a comprehensive collection of the reviews on nanovectors loaded with some paradigmatic NPs, namely curcumin, quercetin, resveratrol, epigallocatechin-3-gallate, thymoquinone, cannabidiol, and silybin, all developed to overcome their biopharmaceutical restrictions, mainly solubility and stability. The study highlights the challenges and limitations of the reported studies, evidencing in many cases the lack of complete knowledge of the mechanistic of nano–bio interactions, the lack of some basic requirements as the encapsulation efficiency and drug loading efficiency, as well as the very limited number of…

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