DEVELOPMENT OF AN ANTIINFECTIVE GTR BARRIER PRODUCT

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The objective of this research is to develop an anti-infective barrier membrane for use in guided tissue regeneration procedures. Doxycycline hyclate powder will be mixed on site into a solution of a biodegradable polymer in a biocompatible solvent, the mixture formed into a semi-solid film with a barrier-forming-kit, and the semi-solid film cut to the size and shape of the periodontal defect to be treated. When placed over the defect it fully solidifies to form a GTR barrier which releases doxycycline in concentrations sufficient to prevent infections at the surgical site and provide a more predictable tissue regeneration in periodontal surgery. Research completed to date has shown that doxycycline can be incorporated into the polymer solution to provide barriers with good handling characteristics, extended release of bioactive drug, and a reduction in periodontal pathogens at GTR surgical sites in dogs. In Phase II, the most promising formulation will be prepared in pilot-scale batches, the product specifications and mixing procedures defined, an Investigational Device Exemption submitted to the FDA, and a pivotal clinical study conducted to determine the effectiveness of the product in providing sustained concentrations of the drug, reduced levels of periodontal pathogens, and clinical efficacy at GTR surgical sites in humans. PROPOSED COMMERCIAL APPLICATION: There is a clinically unmet need for a therapeutic product for the predictable regeneration of periodontal tissues. A biodegradable barrier membrane that provides high concentrations of an antibiotic locally at the surgical site could provide significant clinical advantages in a market estimated at 100 million dollars per year. It is anticipated that such a product would obviate the need for systemic antibiotics and lead to more predictable GTR surgery outcomes.