Formulation and Evaluation of Colon Targeted Oral Drug Delivery System using Natural Polymers and Methacrylic Acid Co Polymers

Abstract

This research aimed to develop a colon-targeted Budesonide drug delivery system using microbial and pH triggers within the framework of Quality by Design (QbD). Natural gums were screened for their potential to create a colon-targeted drug delivery system based on viscosity analysis and enzyme sensitivity studies. Tamarind Gum was selected as the primary candidate based on its excellent viscosity characteristics. For tablet dosage forms, carboxymethyl (CM) Tamarind Gum was chosen, and these tablets were coated with Eudragit S 100 to delay drug release in the upper gastrointestinal tract. Pellet dosage forms were optimized using critical process parameters and formulation variables, super-coated with Eudragit S100 for enhanced colon targeting. Through the Box Behnken Design and Response Surface Optimization methods, the research identified the Design Space (DS) and optimal formulations meeting specific criteria. The results showed that these formulations released less than 10% of the drug in the first 5 hours and over 80% within 9 hours, aligning with colon-targeted drug delivery goals. Histopathology and biochemical analyses of IL-6 and TNF-and#945; confirmed the efficiency of the optimized pellet formulation in treating induced ulcerative colitis in rats compared to standard Budesonide solution. Roentgenography demonstrated that the optimized formulation remained intact for 5 hours and fully disseminated after 7 hours. This research presents a systematic approach to developing colon- targeted Budesonide formulations with delay drug release characteristics, promising clinical applications for colon-related disorders. newline newline