Inflammatory Bowel Disease (IBD), encompassing ulcerative colitis and Crohn’s disease, represents a chronic and relapsing inflammatory condition of the gastrointestinal tract that necessitates site-specific therapeutic intervention. Conventional budesonide formulations are hindered by poor bioavailability, premature drug release, and systemic adverse effects. The present investigation was undertaken to develop and evaluate a smart pH-responsive nanoparticulate system for the targeted colonic delivery of budesonide, aiming to enhance therapeutic efficacy while minimizing systemic exposure. Nanoparticles were formulated using pH-sensitive polymers such as Eudragit® S100, chitosan, and alginate, and optimized for particle size, zeta potential, encapsulation efficiency, and stability. Characterization by Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry(DSC) confirmed drug–polymer compatibility, while Scanning Electron Microscopy (SEM) demonstrated uniform, spherical morphology. In vitro release studies under simulated gastrointestinal conditions exhibited negligible drug release in acidic pH and sustained release at colonic pH, confirming pH-dependent responsiveness. Ex vivo studies revealed enhanced mucosal adhesion and drug retention in colonic tissue. The optimized formulation significantly improved local drug availability and reduced systemic corticosteroid exposure. Overall, the developed pH-responsive budesonide-loaded nanoparticles present a promising, patient-compliant, and efficacious platform for targeted drug delivery in the management of Inflammatory Bowel Disease.
Velmurugan T.1*, Dr. M. Senthilraja2, Dr. Pitta Sriramcharan3 (Wed,) studied this question.