Accelerated stability testing of celecoxib nanoemulsion containing Cremophor-EL

Abstract

Celecoxib (CXB), a selective cyclooxygenase-2 inhibitor has been recommended for the treatment of arthritis and osteoarthritis upon oral administration. However, long term oral administration of celecoxib cause serious gastrointestinal adverse effects. Therefore the aim of the present study was to enhance CXB’s physical and chemical stability using nanoemulsion formulation in order to eliminate gastrointestinal adverse effects of its oral administration. Optimized nanoemulsion formulation was prepared by spontaneous emulsification method. Nanoemulsion was characterized by droplet size, viscosity and refractive index. Stability studies were performed for the period of 3 months. Droplet size, viscosity and refractive index were determined every month. Shelf-life of nanoemulsion formulation was also determined by accelerated stability testing. It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period. However, the changes in these parameters were not statistically significant (p ≥ 0.05). The shelf-life of optimized nanoemulsion formulation was found to be 2.38 years at room temperature. These results indicated that both physical as well as chemical stability of celecoxib can be enhanced in nanoemulsion formulation using Cremophor-EL as surfactant. Key words: Nanoemulsion, celecoxib, shelf life, cremophor-EL.