Development and Evaluation of Dapagliflozin-Loaded Chitosan Nanoparticles for Oral Delivery in Diabetes Mellitus

Abstract

The present study aimed to develop and evaluate Dapagliflozin-loaded chitosan nanoparticles for enhanced oral delivery in the management of diabetes mellitus. Nanoparticles were prepared using the ionic gelation technique employing chitosan as the polymer and sodium tripolyphosphate (TPP) as the cross-linking agent. Five formulations (F1–F5) were prepared by varying the concentrations of chitosan and TPP and were evaluated for particle size, polydispersity index (PDI), zeta potential, entrapment efficiency, drug loading, FTIR, DSC, SEM, in vitro drug release, release kinetics, and stability. The optimized formulation (F4) exhibited a particle size of 296.1 ± 9.4 nm, PDI of 0.271 ± 0.03, zeta potential of +32.7 ± 1.5 mV, entrapment efficiency of 87.8 ± 2.1%, and drug loading of 18.4 ± 0.8%. FTIR and DSC studies confirmed the compatibility of Dapagliflozin with formulation excipients and successful drug encapsulation within the chitosan matrix. SEM analysis revealed predominantly spherical nanoparticles with smooth surfaces and minimal aggregation. The optimized formulation demonstrated a sustained drug release profile with 92.4 ± 1.8% cumulative drug release over 24 hours. Release kinetic analysis indicated diffusion-controlled drug release following the Higuchi model with anomalous transport behavior. Stability studies demonstrated minimal changes in physicochemical properties over a three-month storage period. The findings suggest that Dapagliflozin-loaded chitosan nanoparticles represent a promising oral drug delivery system for sustained antidiabetic therapy.