DEVELOPMENT OF AN ANTIINFECTIVE GTR BARRIER PRODUCT

本研究的目的是开发一种抗感染屏障 用于引导组织再生手术的膜。 强力霉素 hyclate粉末将现场混合到可生物降解的 在生物相容性溶剂中的聚合物，该混合物形成为半固体 膜与屏障形成套件，并将半固体膜切割成尺寸 和待治疗的牙周缺损的形状。 当被放置在 缺陷完全固化形成GTR屏障， 浓度足以预防感染的强力霉素 并提供更可预测组织再生， 牙周手术 迄今为止完成的研究表明， 可以将多西环素掺入聚合物溶液中 具有良好处理特性的屏障， 生物活性药物和减少牙周病原体在GTR手术 网站狗在第二阶段，最有希望的配方将是 制备中试规模批次，产品规格和混合 规定的程序，提交给 FDA和一项关键临床研究， 产品在提供持续浓度的 该药物，降低牙周病原体的水平，和临床疗效 在人类的GTR手术部位。 拟定商业应用： 临床上对治疗性产品存在未满足的需求， 牙周组织的可预测再生。 可生物降解 提供高浓度抗生素的屏障膜 在手术部位局部可以提供显著的临床 在市场上的优势估计为每年1亿美元。 它 预计这样的产品将满足系统性的需求， 抗生素，并导致更可预测的GTR手术结果。

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.