Development and Evaluation of a System for Colonic Delivery of Budesonide

In the present study an attempt has been made to address low solubility issue and colonic delivery of Budesonide by developing enteric coated capsule containing Budesonide in a nano emulsifying drug delivery system. Herein, the formulated liquid SNEDDS was transformed to a solid form by spray draying method. Subsequently, it was filled into capsules coated with pH sensitive polymer, Eudragit S- 100 along with band sealing. However, the drug solubility is an important parameter which was determined in different oils, surfactants and co-surfactants. Ternary phase diagrams were constructed to obtain maximum nano-emulsion area. SNEDDS containing Capmule ®MCM L8 as oil, Tween-80 as surfactant and polyethylene glycol 400 as co-surfactant were formulated to get maximum nano-emulsion in the phase diagram. In vitro drug release of the optimized SNEDDS (particle size 116.32 nm) revealed enhanced drug release in colonic pH as compared to pure drug. The developed SNEDDS of budesonide also demonstrated better activity against ulcerative colitis as evidenced by the gradually diminishing morphological damages in the histopathological studies in the TNBS induced ulcerative colitis in rats. Thus, SNEDDS enhanced the solubility of Budesonide while the enteric coating provides its colonic release.