DEVELOPMENT OF AN ANTIINFECTIVE GTR BARRIER PRODUCT

这项研究的目的是开发一种抗感染屏障 用于引导组织再生程序的膜。多西环素 将水合物粉末现场混合成可生物降解的溶液 聚合物在生物相容的溶剂中，混合物形成半固体 带有阻挡层成型器的薄膜，以及切割成一定尺寸的半固态薄膜 以及待治疗的牙周缺陷的形状。当放置在 缺陷它完全固化，形成GTR屏障，释放 多西环素的浓度足以预防感染 手术部位并提供更可预测的组织再生 牙周手术。到目前为止完成的研究表明 多西环素可以加入到聚合物溶液中以提供 具有良好操控特性的障碍物，延长了释放时间 生物活性药物和牙周病原体在牙周手术中的减少 狗狗的网站。在第二阶段，最有希望的配方将是 中试批次制备、产品规格及调和 规定的程序，提交给调查设备豁免 FDA和一项关键的临床研究，以确定 该产品在提供持续浓度的 药物、降低牙周病原菌水平和临床疗效 在人类的GTR外科手术部位。 建议的商业应用： 临床上对一种治疗癌症的产品的需求尚未得到满足 牙周组织的再生是可预测的。一种可生物降解的 提供高浓度抗生素的阻隔膜 在手术部位的局部可以提供重要的临床 在一个估计每年1亿美元的市场上具有优势。它 预计这样的产品将不再需要系统 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.