The Necessity to Investigate In Vivo Fate of Nanoparticle-Loaded Dissolving Microneedles

The review emphasizes the potential of nanoparticle-loaded dissolving microneedles (DMNs) in enhancing transdermal drug delivery by overcoming the stratum corneum barrier, which limits drug absorption. Despite their advantages, such as high drug loading and controlled release, the clinical application of DMNs is hindered by a lack of understanding of their in vivo fate, which is crucial for approval and use. The document highlights the need for comprehensive in vivo studies to understand the absorption, distribution, metabolism, and excretion (ADME) processes of these formulations. It suggests that understanding the biodistribution and pharmacokinetics of both drugs and nanocarriers is essential, as they may have different in vivo fates. Factors such as protein coronas, nanoparticle size, shape, and surface properties significantly influence their behavior. The review calls for further research to facilitate clinical translation and industrialization, suggesting that in vivo fate should be a critical quality attribute in the quality by design strategy to predict clinical performance and improve success rates.