Improved Therapies for Treatment of Inflammatory Bowel Disease based on the Novel Mesoporous Material Upsalite®

Important results from the project

The ultimate goal was to test Upsalite in man, with the aim to show a dual proof of concept: 1) address the clinical issues associated with the existing treatments for IBD 2) show that Upsalite can be used for modified release of drugs 5-ASA was not compatible (technically) with Upsalite, and could thus not be developed further within the project. Using prednisolone it was shown that it is possible to modify the release of drugs using Upsalite, and that Upsalite can be coated with existing (commercial) methods. Thus, Upsalite can be used for modified release of drugs.

Expected long term effects

5-ASA and Upsalite were noncompatible, despite repeated efforts to load 5-ASA into Upsalite. The focus turned to using prednisolone in order to study the modified release of drugs using Upsalite. In addition, enterocoating was evaluated. The results showed that 1) Prednisolon is compatible with Upsalite 2) Upsalite can be used as a platform for modified release of drugs 3) 5-ASA (for technical reasons) and prednisolon for commercial reasons) could not be developed into products using Upsalite

Approach and implementation

Three work packages in parallel 1) Formulation design. Production of material (drugloaded Upsalite) was designed for obtaining modified release. One of the drugs (prednisolone) was compatible with Upsalite, and was used for validating the concept "Upsalite as a platform for modified release of drugs" 2) Regulatory. We identified studies and CROs in order to take the project to the next step, i.e. studies in humans. 3) Business development and market. Prednisolone had a low market potential to be developed into a modifierad release formulation