article · Medicine in Drug Discovery
Nanoparticles offer significant promise for targeted and controlled drug delivery, yet their expanding use raises serious concerns regarding potential risks to human health and the environment. Nanoparticle toxicity operates through various cellular and molecular mechanisms, notably oxidative stress, inflammation, genotoxicity, and neurotoxicity. These toxicological responses are governed by specific physicochemical properties, including particle size, shape, surface chemistry, and composition. Modern assessment methods increasingly employ advanced in vitro and in vivo models, high-throughput screening, and alternative animal systems such as zebrafish and Caenorhabditis elegans. However, translating these testing tools into safe therapies requires standardised protocols, clear regulatory frameworks, and coordinated input across materials science, toxicology, and pharmacology to address current knowledge gaps.
While nanoparticles can deliver drugs directly to diseased tissues, they can also cause unintended cellular damage. Developing accurate ways to test their safety ensures that new medicines do not cause adverse health or environmental effects, paving the way for safer healthcare technologies.
This work informs pharmaceutical developers, nanomedicine researchers, and regulatory authorities seeking reliable safety assays for nanoparticle formulations. By reviewing screening models and toxicological mechanisms, it aids early-stage safety validation and risk profiling. Because the text evaluates testing methods and regulatory frameworks, its application lies in early-stage preclinical testing rather than near-market deployment.
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• Nanoparticle induced toxicity assessment in drug delivery applications was analyzed. • Nanoparticles toxicity assessment was performed in drug delivery applications. • A critical assessment was made on the current trends in nanotoxicity assessment. • Regulatory guidelines in nanotoxicology were described. Nanoparticles have emerged as a promising tool in the field of drug delivery, offering targeted and controlled release of therapeutic agents. However, the increasing use of nanoparticles has raised concerns about their potential toxicity and adverse effects on human health and the environment. This review article provides a comprehensive overview of the recent approaches in nanotoxicity assessment for drug delivery applications, highlighting the challenges and future prospects in this rapidly evolving field. The article explores into the cellular and molecular mechanisms underlying nanoparticle toxicity, including oxidative stress, inflammation, genotoxicity, and neurotoxicity. The importance of nanoparticle characterization and the role of physicochemical properties, such as size, shape, surface chemistry, and composition, in determining their toxicological profile are emphasized. The article also discusses the current trends in nanotoxicity assessment, focusing on advanced in vitro and in vivo models, high-throughput screening techniques, and the use of alternative animal models, such as zebrafish and C. elegans . The regulatory landscape surrounding nanotoxicology is explored, emphasizing the need for standardized testing protocols and risk assessment frameworks. Furthermore, the article highlights the importance of a multidisciplinary approach, integrating expertise from fields such as material science, toxicology, and pharmacology, to address the complexities of nanotoxicity assessment. By providing a critical analysis of the current state of nanotoxicity research and identifying key knowledge gaps, this review article aims to guide future research efforts and contribute to the development of safer and more effective nanoparticle-based drug delivery systems.
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DOI: 10.1016/j.medidd.2025.100204
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