Formulation Development and Evaluation of Silymarin Chitosan nanoparticles loaded mouth dissolving film

Abstract

This study focuses on the formulation and evaluation of mouth dissolving films (MDF) incorporating silymarin-loaded chitosan nanoparticles, aimed at enhancing the bioavailability and patient compliance of this naturally derived hepatoprotective agent. Silymarin, known for its therapeutic benefits, faces challenges related to solubility and stability, which this formulation seeks to address. Chitosan nanoparticles were prepared using a solvent evaporation method, allowing for the effective encapsulation of silymarin. The resultant nanoparticles were characterized for particle size, zeta potential, and entrapment efficiency, revealing favorable properties for drug delivery. Subsequently, the mouth dissolving films were formulated using hydroxypropyl methylcellulose (HPMC) as the film-forming agent, combined with plasticizers to improve flexibility and disintegration. The physical and mechanical properties of the films were rigorously evaluated, including thickness, tensile strength, and disintegration time, demonstrating rapid dissolution characteristics ideal for sublingual administration. In vitro drug release studies indicated a significant enhancement in silymarin solubility and controlled release profile due to the nanoparticle formulation. Overall, the developed mouth dissolving film presents a promising delivery system for silymarin, potentially improving its therapeutic efficacy and patient adherence. Future work will involve in vivo studies to confirm the pharmacokinetic advantages of this novel formulation.