Objective
A novel disulphide polymer has been synthesised which has been shown to be susceptible to reductive degradation in the colon. The polymer has been coated onto tablets, which have been administered to man. The results from the human testing were extremely encouraging.
A colon-targeted delivery system based on a starch capsule coated with conventional enteric polymers was developed. When this formulation was tested in main, eight out of nine coated capsules disintegrated in the colon. The remaining capsule disintegrated in the terminal ileum.
From studies in rats and a fistulated pig model, an absorption enhancer composition was identified, based on the synergistic effects of two materials. A formulation containing the enhancer and a model peptide encapsulated into a coated starch capsule has been tested in man.
An enteric-coated 5-ASA pellet formulation has been developed. Following extensive in vitro testing, the formulation has progressed to clinical testing in man. Results are awaited.
The availability of the reliable colonic targeting system, based upon biocompatible coating materials, would have a ready route for commercial exploitation in the delivery of conventional drug substances for the local treatment of large bowel disorders.
Improved colonic delivery would also have a major impact on the market for oral controlled release products and more importantly a well conceived system could permit the successful oral delivery of biopharmaceuticals, such as insulin, calcitonin, growth hormone, interferons and colony stimulating factors. Novel biocompatible polymers, that degrade selectively in the colonic region of the human gastrointestinal tract, will be used as coating agents for conventional oral dosage forms so as to provide a delivery system that after oral administration remains intact from mouth to caecum.
The in-vivo disintegration of the device will be triggered by a natural characteristic of the large bowel so as to guarantee the selectivity of the system, ie pre-programmed release. In the case of peptide delivery, it is highly likely that additional performance modifiers (critical components) will have to be added to the formulation in order that satisfactory oral bioavailability can be achieved.
Following the successful completion of the defined research programme, the partners will locate suitable large companies, preferably European, for the commercial exploitation of the final prototype formulations.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences biological sciences biochemistry biomolecules
- natural sciences chemical sciences polymer sciences
- engineering and technology materials engineering coating and films
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
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Coordinator
NG7 2RQ Nottingham
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.