Translational Liposomal Drug Delivery Systems: Clinically Approved Formulations, Scalable Manufacturing Strategies,...

Liposomal drug delivery systems have evolved into clinically validated platforms across diverse therapeutic areas. This review aims to provide a translational perspective by linking fundamental formulation principles with clinically approved products and industrial manufacturing strategies.

A structured narrative review was undertaken to examine liposomal formulations approved by major regulatory authorities across a range of clinical applications, including oncology, infectious diseases, vaccination, pain management, gene therapy, and regenerative medicine. The analysis focused on key formulation parameters, manufacturing techniques, and characterization methods. Relevant studies were identified through comprehensive searches of major scientific databases, including PubMed, Scopus, Web of Science, and ScienceDirect, as well as patent platforms such as Google Patents and Espacenet. Study selection was guided by predefined inclusion and exclusion criteria, prioritizing translational relevance, formulation strategies, manufacturing approaches, and clinically approved liposomal systems.

Lipid composition, vesicle size, surface functionalization, and release characteristics were identified as critical determinants of pharmacokinetics, therapeutic efficacy, and safety. Scalable and environmentally conscious manufacturing approaches, including supercritical fluid technologies, microfluidic systems, and solvent-reduction strategies, demonstrated strong alignment with regulatory and sustainability expectations. In characterization, emerging artificial intelligence-based tools showed potential for improved vesicle identification, size distribution analysis, and morphological assessment compared with conventional techniques such as dynamic light scattering and electron microscopy.

The integration of advanced formulation design, scalable manufacturing, and data-driven characterization enhances the translational potential of liposomal systems. However, challenges remain regarding standardization, regulatory acceptance of novel analytical tools, and reproducibility at industrial scale.

Liposomal drug delivery systems represent a mature yet evolving platform. Bridging laboratory innovations with clinically and industrially viable solutions requires coordinated advances in formulation, manufacturing, and characterization. This review provides a practical framework for the development of next-generation liposomal systems with translational relevance.