Multifractal Analysis and Experimental Evaluation of MCM-48 Mesoporous Silica as a Drug Delivery System for Metformin...

Background: This study explored the potential of MCM-48 mesoporous silica matrices as a drug delivery system for metformin hydrochloride, aimed at improving the therapeutic management of type 2 diabetes mellitus. The objectives included the synthesis and characterization of MCM-48, assessment of its drug loading capacity, analysis of drug release profiles under simulated physiological conditions, and the development of a multifractal dynamics-based theoretical framework to model and interpret the release kinetics. Methods: MCM-48 was synthesized using a sol-gel method and characterized by SEM-EDX, TEM, and nitrogen adsorption techniques. Drug loading was performed via adsorption at pH 12 using metformin hydrochloride solutions of 1 mg/mL (P-1) and 3 mg/mL (P-2). In vitro dissolution studies were conducted to evaluate the release profiles in simulated gastric and intestinal fluids. A multifractal dynamics model was developed to interpret the release kinetics. Results: SEM-EDX confirmed the uniform distribution of silicon and oxygen, while TEM images revealed a highly ordered cubic mesoporous structure. Nitrogen adsorption analyses showed a high specific surface area of 1325.96 m²/g for unloaded MCM-48, which decreased with drug loading, confirming efficient incorporation of metformin hydrochloride. The loading capacities were 59.788 mg/g (P-1) and 160.978 mg/g (P-2), with efficiencies of 99.65% and 89.43%, respectively. In vitro dissolution studies showed a biphasic release profile: an initial rapid release in gastric conditions followed by sustained release in intestinal fluids, achieving cumulative releases of 92.63% (P-1) and 82.64% (P-2) after 14 hours. The multifractal dynamics-based theoretical release curves closely matched the experimental data. Conclusions: MCM-48 mesoporous silica effectively enhanced metformin delivery, offering a controlled release profile well-suited for type 2 diabetes management. The multifractal theoretical framework provided valuable insights into drug release dynamics, contributing to the advancement of innovative drug delivery systems.