Innovative 3D-Printed Devices with Modified Prednisolone Release for Colon-Targeted Drug Delivery Systems.

Abstract

Background: Prednisolone conventional tablet is a drug commonly used to treat inflammatory bowel disease (IBD). However, the long-term use of high doses of prednisolone can lead to gastric irritation, risk of infection, and other systemic complications. These limitations of the drug can be overcome by using three-dimensional (3D) printing technology with pH-dependent approaches. Objectives: This study aimed to develop 3D-printed devices containing prednisolone tablets and gel with an enteric coating for colon-targeted modified release. Methods: 3D-printed drug-containing devices (CDDs) were designed and divided into two classifications, including devices for prednisolone tablets (PTDs) and devices for prednisolone gel (PGDs). CDDs were fabricated using fused deposition modeling (FDM). The morphology of the CDDs was assessed using a microscope. The tablets and gel of prednisolone were loaded into CDDs depending on the type of device, and the CDDs were coated by Eudragit^® S100. In vitro drug release studies were investigated using dissolution apparatus II in simulated gastric medium (pH 1.2) for 2 h, simulated intestinal medium (pH 6.8) for 2 h, and simulated colonic medium (pH 7.4) for 20 h. Results: The prednisolone-loaded CDDs with enteric coating were protected from drug release before reaching the colon. The dissolution profile of prednisolone from CDDs showed no drug release in the simulated gastric and simulated intestinal medium, with drug release initiated under simulated colonic medium and sustained release maintained for up to 24 h. Conclusions: These findings showed that CDDs have potential for delivering prednisolone to the colon with controlled drug release under simulated in vitro gastrointestinal conditions. Furthermore, these CDDs could be adapted for other drugs.