Development of an Optimized Budesonide Delivery System: A Controlled-Release Approach for Targeting the Colon

This study focused on the development and optimization of a colon-targeted Budesonide tablet formulation designed for controlled release and targeted delivery to the colon. A combination of controlled-release polymers (Xanthan Gum and Hypromellose K4M) and coating polymers (Eudragit S100 and Eudragit L100) was utilized to achieve the desired drug release profile. A systematic approach using fractional and full factorial designs was employed to identify the key variables influencing drug release at specific time points. The formulation was optimized to ensure minimal premature release in the upper GIT and maximum release in the colon. In vitro dissolution studies revealed that the optimized formulation closely matched the reference-listed drug (RLD), with 18.07% release at 2 h, 42.63% at 4 h, 84.78% at 8h and 91.32% at 12 h. The similarity factor (f2) of 83 and difference factor (f1) of 3 confirmed the high level of similarity between the two formulations. The optimized formulation successfully delivered Budesonide in a controlled manner, providing a cost-effective and scalable solution for treating inflammatory bowel diseases.