Objective
- Development of new dosage forms with the ability to reside for long periods of time in the colon. The newly developed drug carriers will be of two types :
- mucoadhesive polymeric carriers;
- buoyant platforms.
These are designed to deliver two classes of drugs : molecules aimed at local treatment of colon diseases and molecules susceptible to enzymatic degradation such as peptide drugs;
- In vitro and in vivo studies in which the mucoadhesive polymers will be tested as to their ability to function successfully, i.e. adhere to mucosal tissues or float in physiologic fluids;
- In vivo studies to test the viability of the hypothesis that prolongation of residence time in the colon can increase the bioavailability of enzyme susceptible drugs such as peptide drugs;
- Development of an animal model (pig) in which in vivo studies will be performed validates the prolonged residence time of the drug carriers.
Expected outcome
- Localisation of anti-IBD drugs such as salicylate derivatives (5-amino salicylic adic) steroids with local action and hepatic clearance such as budesonide, immunosuppressive agents such as cyclosporine;
- Early stages of colon cancer (when systemic prevention of possible metastasis in the blood comment is still not necessary);
- GI absorption of highly lipophilic molecules;
- GI absorption of peptide drugs or vaccines.
Expected Outcome
- Localisation of anti-IBD drugs such as salicylate derivatives (5-amino salicylic adic) steroids with local action and hepatic clearance such as budesonide, immunosuppressive agents such as cyclosporine;
- Early stages of colon cancer (when systemic prevention of possible metastasis in the blood comment is still not necessary);
- GI absorption of highly lipophilic molecules;
- GI absorption of peptide drugs or vaccines.
Activities
- Polymers blends of Eudragit RL with Polycarbophil (acid form) in different ratios will be prepared and tested for physicochemical and mucoadhesion properties;
- Fabrication of mucoadhesive drug delivery systems. The optimal polymer blends will be formulated into solid dosage forms and tested with two drug markers (at least one of which will be a protein drug) in rats for regional GI mucoadhesion;
- New buoyant dosage forms will be prepared and tested in vitro and in vivo (dogs);
- Novel delivery systems will be prepared and tested for selfbuoyancy properties in bench chemostat;
- The novel formulations will be tested in pigs for increase in dosage form residence time using gamma scintigraphy;
- Pilot human studies will conclude the research.
- Polymers blends of Eudragit RL with Polycarbophil (acid form) in different ratios will be prepared and tested for physicochemical and mucoadhesion properties;
- Fabrication of mucoadhesive drug delivery systems. The optimal polymer blends will be formulated into solid dosage forms and tested with two drug markers (at least one of which will be a protein drug) in rats for regional GI mucoadhesion;
- New buoyant dosage forms will be prepared and tested in vitro and in vivo (dogs);
- Novel delivery systems will be prepared and tested for selfbuoyancy properties in bench chemostat;
- The novel formulations will be tested in pigs for increase in dosage form residence time using gamma scintigraphy;
- Pilot human studies will conclude the research.
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Programme(s)
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Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Topic(s)
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Funding Scheme
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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.
Coordinator
NG7 2RD 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.