Project: Adhesive silicone hydrogel for Controlled Oral Drug Elution

The aim of the CODE project is to develop a drug delivery system for oral drug administration. This project proposes to combine the advantages of a silicone hydrogel device (developed by BIOMODICS) with the bioadhesive effect of a chitosan based hydrogel (developed by KITOZYME). This system will be evaluated in vitro and in vivo by BIONEER for the oral administration of both water soluble and poorly water soluble model drugs._x000D__x000D_The system is unique because it is based on impregnated silicone instead of a coating or a tea bag solution with too rapid release profile for the drug. The silicone hydrogel is flexible, tunable and can be organized to deliver drugs in a very controlled way for several months._x000D__x000D_The silicone hydrogel will solve a range of problems associated with current delivery technologies and will enable the design of custom made non-invasive delivery systems. These systems are preferred by pharmaceutical companies due to the ease of administration with no needles and a minimal need for health care professionals. Moreover, non-invasive administration routes have shown to result in significantly better patient compliance._x000D__x000D_There is a strong societal need for drug delivery technologies that enable non-invasive delivery with a release rate that can be modified to fit the requirement of a specific treatment. Such technologies will result in fewer side effects, better primary effects and easier drug administration and thus will benefit the patient._x000D_The commercial importance of drug delivery is evidenced by the large sums being spent within EU and in private companies to improve both the effects of existing drugs and the administration of these drugs. _x000D__x000D_Many companies therefore prefer the oral route for drug administration and invest much effort in developing delivery systems that can facilitate absorption of drug in the gastro-intestinal tract. Traditionally oral dosage forms are tablets, produced by granulation and compaction. This results in a symmetrical shape and a resulting drug release from all sides. Further drug absorption from a normal tablet is restricted by the transit time of the small intestine, which is approximately 3 hr. Thereafter the drug will have entered the colon where many drugs are not absorbed._x000D__x000D_A novel approach to meet these drug administration needs, is a new unprecedented drug delivery concept, developed by Biomodics, based on interpenetrating networks inside tailored silicone matrices. The silicone matrix can then by shaped into the desired form, which will depend on the nature of the medical treatment, i.e. the specific disease and route of administration. The silicone matrix will mimic tape worms in two ways. The route through the gastro-intestinal tract will be delayed by a worm-shape. This will be further enhanced and controlled by introducing a bioadhesive. We have chosen chitosan for this function. This allows for delivery of drugs in a controlled way._x000D__x000D_Chitosan is a promising candidate for a drug delivery system because it exhibits a unique set of properties including safety, biodegradability, muco-bioadhesion, and drug permeability enhancing properties. The muco-bioadhesive property of the chitosan is particularly interesting for drug delivery systems because it can increase the retention time of the drugs in contact with mucosal tissue leading to an improved transmucosal exchange of drugs. Another interesting aspect of this biopolymer is the ability to process it into different forms and most interestingly into gels/hydrogels formulations with tunable characteristics for drug delivery systems._x000D__x000D_The proposed consortium, consisting of BioModics (Denmark, SME), Bioneer (Denmark, SME), and KitoZyme (Belgium, SME), presents a unique collection of expertise extremely well suited to the proposed project._x000D__x000D_Biomodics has developed the silicone hydrogel device and brings expertise in development of this material._x000D__x000D_KitoZyme is a leader in the manufacturing of ultra-pure chitosan from vegetal sources according to GMP and dedicated to medical/pharmaceutical applications. KitoZyme has expertise in the formulation of chitosan into hydrogels with tunable characteristics. During the CODE project, KitoZyme will be responsible for the development of the chitosan-based hydrogels and will actively collaborate with BIOMODICS in the design of the combined system (silicon+chitosan hydrogel)._x000D__x000D_Bioneer is a recognized not-for-profit-research institute that develops services and technology platforms within biomedicine, including pharmaceutical services such as drug formulation, drug stability analysis and predictive gastro-intestinal drug release models. In this project Bioneer is responsible for the pharmaceutical characterization of the silicone hydrogels, including the release profiles of drugs in media simulating the gastro-intestinal fluids._x000D_

Acronym CODE (Reference Number: 5076)
Duration 28/07/2010 - 28/07/2013
Project Topic The CODE project objective is to develop the first fully integrated silicone hydrogel drug delivery system. By fulfilling this objective large unmet market demands for easy controlled and safe long time oral administration of therapeutic drugs will be met.
Project Results
(after finalisation)
Coating of silicon-based IPN with differents types of ultra-pure chitosan or new chitosan derivatives produced by Kitozyme by dipping process. _x000D_Once tested for adhesion properties, one of the coatings has shown interesting properties, which can open the door to new cotaing and drug delivery technologies.
Network Eurostars
Call Eurostars Cut-Off 3

Project partner

Number Name Role Country
3 Bioneer A/S Partner Denmark
3 BioModics Coordinator Denmark
3 Kitozyme Partner Belgium