The present research work was to formulate optimize and evaluate hydrocortisone-loaded niosomal gel for the management of rheumatoid arthritis. Method: Niosomal gel was successfully prepared by lipid-thin film hydration process and optimized by using 2 3 full factorial designs using three independent variables (tween 80 concentration, cholesterol concentration, and sonication time) and three dependent variables (cumulative drug release, mean particle size and entrapment efficiency). The effect of all variables was assessed by response surface methodology. Results: The prepared formulations were evaluated in terms of particle size, in-vitro drug release, encapsulation efficiency, zeta potential, viscosity, and spreadability. Based on response surface methodology, S6 formulation was found to be the best formulation with entrapment efficiency of 92.27%, in-vitro drug release of 75.61% in 8 hrs, and mean particle diameter of 121.58 nm. The stability studies indicated that all the formulations are stable as none exhibited significant drug content change over time. Conclusion: The study indicated the successful development of hydrocortisone-loaded niosomal gels with improved penetration, good homogeneity, and enhancement of duration of action. It can thus be concluded that the developed gel could be an effective treatment for rheumatoid arthritis.
INTRODUCTION:Hydrocortisone acetate belongs to the class of corticosteroids, which is a synthetic or semi-synthetic derivative of the natural hormone cortisol secreted by adrenal cortex 1, 2 . FDA approved it in 1952 for clinical use in managing inflammatory diseases like rheumatoid arthritis, psoriasis, asthma, eczema, and many more 3, 4 . The conventional therapy with hydrocortiosone is based on systemic delivery by different routes, which leads to serious complications 5-7 .