MULTIDRUG DELIVERY MICROPARTICLE COATINGS FOR ORTHOPEDIC DEVICES

描述(由申请人提供)：该SBIR项目的目标是开发用于植入性整形外科设备的药物洗脱生物兼容涂层。第一阶段工作的具体目标是对整形外科材料进行涂层，以延长从生物可吸收微粒与光反应聚合物基质相结合的3类抗菌药(防腐剂、抗生素和杀菌多肽)的同时输送。这项新技术的成功展示将为骨科植入物进一步开发生物相容性涂层提供基础，该涂层结合了抗感染、疼痛控制和伤口愈合的各个方面。主要的创新将是将载药的可生物吸收微粒固定在具有光反应聚合物基质的可植入表面上的技术。将制备适合于延长输送不同溶解度的低分子药物的颗粒组合物，以及选择各自洗脱速率的生物大分子。这些载药颗粒将被固定在光交联聚合物膜中，该膜具有生物相容性和稳定性，可以在植入过程中保持颗粒。这种药物洗脱医疗器械涂料中的下一代技术将是载药可降解颗粒技术和潜在活性聚合物固定化技术相结合的结果。第一阶段工作中药物洗脱微粒固定化的示范将为第二阶段项目提供理由，以优化包衣技术的成分以及在动物身上的安全性和有用性测试。关键词(8max)：抗菌药物洗脱装置涂层，可降解微粒固定化。潜在商业应用概述：可植入医疗设备涂层中多种药物的受控输送预计将对药物洗脱可植入设备市场做出重大贡献，到2005年将达到50亿至60亿美元，包括整形外科设备、支架、血管移植导管和包裹、植入生物传感器、眼科和美容植入物，在10年内总市场潜力将超过200亿美元。

DESCRIPTION (provided by applicant): 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.