Development and Analytical Characterization of Liposomes: A Comprehensive Approach

Liposomes have emerged as versatile drug delivery systems, widely employed in pharmaceuticals due to their biocompatibility, controlled release properties, and ability to encapsulate both hydrophilic and lipophilic drugs. This review comprehensively explores the development and analytical characterization of liposomes, highlighting essential parameters such as morphology, particle size, zeta potential, and membrane fluidity. Advanced analytical techniques, including spectroscopy, chromatography, and microscopic imaging methods, are discussed for precise liposomal evaluation. Key approaches for assessing encapsulation efficiency, drug release kinetics, and stability are outlined, emphasizing their impact on formulation performance. Furthermore, the application of the Quality by Design (QbD) framework in liposomal development is detailed, with a focus on defining critical quality attributes (CQAs), material attributes, and process parameters to ensure robust product quality. Regulatory perspectives from the FDA, EMA, and ICH are highlighted to address standardization challenges in liposomal characterization. Emerging advancements such as smart liposomal systems, novel analytical tools, and scalable manufacturing strategies are also discussed. This review offers a comprehensive guide for researchers and pharmaceutical scientists seeking to improve liposomal formulation development and characterization techniques.