Colonic budesonide delivery by multistimuli alginate/Eudragit® FS 30D/inulin-based microspheres as a paediatric formulation

The purpose of this study was to develop an oral paediatric formulation of budesonide (BUD) for the treatment of inflammatory bowel disease. A formulation realized as microspheres using the prilling/vibration technique is proposed as an innovative drug delivery system ensuring BUD-specific colonic release in response to different triggers, such as pH, transit time, and resident microbiota. BUD, or the inclusion complex BUD/hydroxypropyl-β-cyclodextrin, was loaded into microspheres consisting of different ratios of alginate, Eudragit® FS 30D, with or without inulin. Sixteen formulations are produced that show high yields and encapsulation efficiencies, ensuring a homogenous distribution of BUD into the matrix. Microsphere diameters of