Innovative drug formulation for targeted release of Rifaximin based on polymer nanotechnology

Host Organisation:	Medochemie Ltd
Partner Organisation(s):	PA1. Biogena API Ltd
Project Budget:	1.860.960,00 €
IDEK Funding:	892.908,00 €

The purpose of this project is to develop, get marketing authorisation license and market a medicinal product for human use that contains Rifaximin 400 mg modified release, nanoparticle formulation. The product is intended to be administered twice per day as a treatment of inflammatory bowel disease (Crohn’s disease and ulcerative colitis). The proposed medicinal product consists of an original combination of a nano-particle formulation with a modified release mechanism both aiming to increase the availability of rifaximin in the colon, the site of action. The new technology will enable the production of Rifaximin in the form of oral tablets or capsules of 400 mg strength, using nano-dispersed Rifaximin on polymer nanoparticles.

For the successful implementation of the project, Medochemie ltd (a generic pharmaceutical company) will co-operate with Biogena API ltd (an Active Pharmaceutical Ingredient producer), in order to develop and produce the final product on a commercial scale. Biogena will be responsible for the development and production of the raw material Rifaximin nanoparticles. Medochemie will investigate the formulation and eventually produce the final drug product in the form of oral tablets or capsules, based on in-vivo bioequivalent studies that will be conducted during the present project. This project was designed based on latest technological achievements combining various research fields, in order to overcome a global problem (affecting about 15% of the population). The design of the project combines all the necessary factors in order to build the best network, for the preparation of an innovative product, ready to enter successfully the global market.