Formulation of gliclazide using self-nano-emulsification technology

Abstract

Self-nano-emulsifying drugs delivery systems present an effective drug delivery system for the formulation of a hydrophobic drug with poor water-solubility. Gliclazide is practically insoluble in water and is amenable for self-nano-emulsifying drug delivery. This study aimed to develop a formulation of gliclazide using Cremophor RH 40 and Tween 20 with capryol 90 as oil vehicle. A solubility study, particle size analysis and ternary phase diagram were developed to select the optimal formulation to take forward to stability testing. Accelerated physical stability and self-emulsification studies were performed. They were also compared for globule size, transmittance, polydispersity index and zeta potential. The solubility was greatest in Capryol 90 64.86 mg/mL, Cremophor RH 40 44.98 mg/mL, PEG 400 105.66 mg/mL, and Tween 20 86.83 mg/mL. The construction of the ternary phase diagram in the formulation using cremophor 40 as surfactant has good characteristics and wide area in nano-emulsifying formation than Tween 20. Gliclazide can be formulated and exhibits good stability in a self-nano-emulsifying drug delivery system.