Development, Characterization and in Vivo Hepatoprotective Evaluation of Ellagic Acid-Loaded Nanocapsules: A Novel Nanoformulation Approach

Abstract

Ellagic acid (EA) is a naturally occurring polyphenolic compound widely investigated for its antioxidant, anti-inflammatory, and hepatoprotective properties. However, its therapeutic application may be limited by poor aqueous solubility, low bioavailability, and restricted dissolution, which can reduce its effective delivery to biological systems. The present study was undertaken to develop and characterize ellagic acid-loaded nanocapsules (EAN) as a potential nanoformulation for improving the delivery and hepatoprotective activity of EA. Initially, comprehensive preformulation studies of EA were performed to evaluate its physicochemical characteristics and compatibility with selected formulation components. EAN were subsequently prepared using a suitable nanocapsule formulation technique and evaluated for physicochemical and pharmaceutical characteristics, including particle size, polydispersity index, zeta potential, morphology, drug content, entrapment efficiency, and in vitro drug-release behavior. The optimized formulation was further investigated for its hepatoprotective potential in an appropriate experimental animal model of liver injury and compared with free EA. Biochemical parameters associated with hepatic function, oxidative stress, and tissue architecture were assessed to determine the protective effect of the formulation. The developed EAN formulation demonstrated nanoscale characteristics and effective incorporation of EA within the nanocapsule system. Comparative biological evaluation was performed to determine whether nanoencapsulation could improve the hepatoprotective response of EA. Histopathological examination was additionally conducted to assess hepatic tissue protection. Overall, the findings support the potential of ellagic acid-loaded nanocapsules as a promising nano-based delivery system for hepatoprotective applications, subject to further optimization and comprehensive pharmacological and safety evaluation.