The goal of this SBIR project is to develop drug-eluting biocompatible coatings for implantable orthopedic devices. The specific goal for the Phase I effort is the coating of orthopedic material for extended simultaneous delivery of 3 classes of antimicrobial drugs (antiseptic, antibiotic and microbiocidal polypeptide) from bioabsorbable micro particles combined in a single coating step with photoreactive polymer matrices. Successful demonstration of this new technology will provide the basis for further development for orthopedic implants of biocompatible coatings combining various facets of infection resistance, pain control, and wound healing. The primary innovation will be technology for immobilizing drug-loaded bioabsorbable micro particles on implantable surfaces with photoreactive polymer matrices. Particle compositions suitable for extended delivery of low molecular weight drugs of differing solubilities, and biological macromolecules, at chosen respective elution rates, will be prepared. These drug-loaded particles will be immobilized in a photocrosslinked polymer film which is biocompatible and stable to hold the particles during implantation. This """"""""next generation"""""""" technology in drug-eluting medical device coatings will result from the combination of drug-loaded degradable particle technology with latent-reactive polymer immobilization technology. Demonstration of drug-eluting micro particle immobilization in the Phase I effort will provide justification for a Phase II project for optimizing the components of the coating technology and safety and usefulness tests in animals. Key words (8 max): Antimicrobial drug-eluting device coatings, degradable micro particle immobilization. Summary of potential commercial applications: Controlled delivery of multiple drugs from implantable medical device coatings is expected to contribute significantly to the drug-eluting implantable device market reaching $5 to 6 billion by 2005, including orthopedic devices, stents, vascular graft catheters and wraps, implanted biosensors, ophthalmic, and cosmetic implants, with a total market potential of greater than $20 billion within 10 years. ? ? ? ?
