Recent Trends in the Development and Clinical Translation of Polymer-based Targeted Therapeutic Nanoparticle.

Polymeric nanoparticles are a state-of-the-art innovation in nanomedicine, offering site-specific drug delivery, an improved pharmacokinetic profile, and a reduced systemic toxic profile. These nano systems usually range in size between 10 to 100 nm, and have the ability to trap a wide range of pharmacological agents, releasing them on a timed basis to specific sites related to the disease, which improves clinical outcomes. Other novel applications of nanoparticles have included polymer-metal theranostic nanoparticles, which combine both diagnostic and therapeutic functions into a single platform. Further development of the polymeric nanocarrier to clinical application is however complex because of the complex design variables, lack of batch-to-batch properties, scale effects, as well as regulatory uncertainty, due to the fact that the formulation and optimisation of nanoparticles is a long-term and intricate process, scientists actively use artificial intelligence (AI) and machine learning (ML) to learn more about the pattern of drug release in nanoparticles, optimisation of AI and ML is also being done. These barriers are being overcome more and more by using artificial intelligence (AI) and machine learning (ML) to design and optimise nanoformulations. These tools facilitate the forecasting of nanoparticles' behaviour, speed up formulation development, and optimise the pre-clinical and clinical workflow. The success rate of regulatory approvals of polymeric drug delivery systems is, however, modest despite encouraging pre-clinical outcomes. The downfall of the projects is usually linked to inadequate physicochemical characterisation, safety issues and vague regulatory pathways. However, some formulations have managed to overcome these challenges, albeit with the need for a robust design plan, thorough pre-clinical testing, and initial interaction with regulatory authorities. This review explores the rationale behind the development of polymeric nanoparticles, recent AI-driven advancements, and the unique dual-functional capabilities of polymer-metal theranostics. It also examines the factors influencing success or failure in clinical and regulatory settings. Collectively, these insights emphasise the transformative promise of polymeric nanomedicine and highlight the urgent need for integrated technological and regulatory approaches to expedite clinical translation.