DEVELOPMENT AND CHARACTERIZATION OF NANOSPONGES LOADED HYDROGEL FORMULATION CONTAINING NYSTATIN

Khush Nandan Kumar*, Naveen Gupta, Hemant Agrawal

ABSTRACT

The present study was aimed at the development and evaluation of a Nystatin-loaded nanosponge gel formulation for enhanced topical antifungal therapy. Nystatin is a polyene antifungal drug widely used in the treatment of fungal infections; however, its conventional formulations are associated with limitations such as poor permeability, low retention time, and limited stability. To overcome these drawbacks, nanosponge technology was employed to achieve controlled drug release, improved stability, and enhanced topical delivery. Pre-formulation studies of Nystatin were carried out to determine its physicochemical properties, including organoleptic characteristics, solubility, melting point, pH, UV spectroscopic analysis, and FTIR studies. The λ-max of Nystatin was found to be 290.0 nm, and the calibration curve exhibited excellent linearity within the concentration range of 10–60 µg/ml. FTIR studies confirmed the presence of characteristic functional groups. Nystatin-loaded nanosponges were prepared by the hot melt method using β-cyclodextrin as the polymer and diphenyl carbonate as the cross-linking agent. The prepared formulations were evaluated for particle size, zeta potential, surface morphology, and entrapment efficiency. Among all formulations, F2 showed the most promising results with a particle size of 120.41 nm, zeta potential of −35.4 mV, and entrapment efficiency of 98.57%. The optimized nanosponge formulation was incorporated into a carbopol-based gel and further evaluated for pH, viscosity, spreadability, skin irritation, and in-vitro drug release. The gel formulation exhibited satisfactory physicochemical properties with good homogeneity, suitable viscosity, excellent spreadability, and no signs of skin irritation. In-vitro drug release studies demonstrated sustained and controlled release behavior, with formulation F2 showing the highest cumulative drug release of 97.43% over 15 hours. Stability studies conducted under accelerated conditions confirmed the stability of the formulation with minimal changes in pH and viscosity. The findings of the study concluded that the developed Nystatin-loaded nanosponge gel formulation is a promising topical drug delivery system capable of enhancing antifungal efficacy, improving drug stability, prolonging drug release, and increasing patient compliance.

Keywords: Nystatin; Nanosponges; Topical drug delivery; ?-cyclodextrin; Controlled drug release; Entrapment efficiency; Carbopol gel; In-vitro drug release; Stability studies.