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Abstract

FORMULATION AND EVALUATION OF SAXAGLIPTIN-LOADED POLYMERIC NANOSPONGES FOR SUSTAINED ANTIDIABETIC THERAPY

Deepak Jaiswal*, Satkar Prasad

RKDF School of Pharmaceutical Sciences, Bhabha University, Bhopal (M.P.)

ABSTRACT

Saxagliptin is an effective oral antidiabetic drug used in the management of type 2 diabetes mellitus; however, its therapeutic efficacy is limited by rapid drug release and the need for sustained delivery. The present study aimed to formulate and evaluate Saxagliptin-loaded nanosponges to achieve controlled drug release and improve antidiabetic performance. Nanosponges were prepared by the emulsion solvent diffusion method using ethyl cellulose as the polymer, polyvinyl alcohol (PVA) as the stabilizer, and Pluronic F68 as the surfactant. Six formulations (F1–F6) were developed by varying the concentrations of polymer and stabilizers and were evaluated for percentage yield, entrapment efficiency, particle size, zeta potential, surface morphology, in vitro drug release, release kinetics, α-amylase inhibitory activity, and stability. Among all formulations, F5 exhibited the highest percentage yield (88.56 ± 1.14%) and entrapment efficiency (86.65 ± 1.45%). The optimized formulation showed a mean particle size of 157.2 nm with a zeta potential of +17.0 mV, indicating good colloidal stability, while scanning electron microscopy confirmed the formation of spherical porous nanosponges. The optimized formulation demonstrated sustained drug release of 97.36 ± 0.41% over 12 h compared with the rapid release of the plain drug. Drug release followed first-order kinetics (R² = 0.9950), suggesting concentration-dependent release. The α-amylase inhibition study revealed superior inhibitory activity of the optimized nanosponge formulation with an IC₅₀ value of 15.68 µg/ml, compared with 19.24 µg/ml for the standard drug acarbose. Stability studies indicated that the optimized formulation remained physically stable with minimal changes in particle size and entrapment efficiency over three months. The developed Saxagliptin-loaded nanosponge formulation demonstrated satisfactory physicochemical characteristics, sustained drug release, enhanced in vitro antidiabetic activity, and acceptable stability, indicating its potential as a promising controlled-release drug delivery system for the management of type 2 diabetes mellitus.

Keywords: Saxagliptin, Nanosponges, Emulsion solvent diffusion, Controlled drug delivery, Ethyl cellulose, Entrapment efficiency, In vitro drug release, ?-Amylase inhibition, Stability studies, Type 2 diabetes mellitus.


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