A New High-Level Disinfectant for Medical Instruments

描述(由申请人提供)： 我们开发了一种新型的双醛冷高层消毒/灭菌产品，用于医疗器械特别是热敏纤维内窥镜的消毒/灭菌，在20摄氏度的条件下，浓度低至0.5%，在不到30分钟的时间内，对结核分枝杆菌的杀灭效果为100%。我们的制剂在2%、1%和0.5%的稀释度下，在20摄氏度时对枯草杆菌和产孢杆菌也表现出杀菌活性。这些制剂在活性的pH值下足够稳定。该第二阶段提案旨在将我们的产品从可行性论证级别提升到适销对路的高级消毒产品，该产品具有可接受的使用寿命和储存稳定性，不会损坏或改变医疗设备的功能，在20摄氏度的条件下具有杀芽胞和快速杀菌作用，以确保快速周转时间，并将满足联邦(510K)批准的安全性和有效性要求。建议在FDA的GMP和GLP许可下，将我们产品的有效成分的大规模、廉价的合成及其分析优化为一套标准操作程序。将针对稳定性、材料兼容性、用户友好性和消毒/灭菌能力设计优化的配方，以满足510(K)通知市场的联邦功效和安全要求。这将通过在这里提出的五个具体目标进行研究来实现。基于我们产品的活性成分在第一阶段研究中展示的有前景的数据，我们已经提交了美国专利申请。同样的数据也表明，我们的产品在拟议的第二阶段研究中的成功也是可以预见的，这导致FDA批准反对510(K)通知。该产品可以帮助遏制许多医院感染，这些感染影响到多达200万公民，每年造成超过450万美元的经济损失。我们的产品有潜力根除与当今HLD代理有关的问题，并几乎占领整个市场。

DESCRIPTION (provided by applicant): We have developed a new dialdehyde based cold high-level disinfection/sterilization product for treatment of medical instruments specially heat sensitive fiberoptic endoscopes and have demonstrated that it is 100% effective against Mycobacterium tuberculosis in less than 30 minutes at 20 degree Celcius at a concentration of as low as 0.5%. Our formulations at 2%, 1% and 0.5% dilutions, also exhibited sporicidal activity against B. subtilis & C. sporogenes at 20 degree Celcius. The formulations were stable enough at the pH of activity. This Phase-II proposal aims to elevate our product from the level of feasibility demonstration to that of marketable high level disinfection product that has acceptable use life and storage stability, will not damage or alter the functionality of medical equipment, is sporicidal & rapidly tuberculocidal at 20 degree Celcius to assure fast turn around time, and will meet the safety and efficacy requirements for federal (510k) approval. It is proposed that a large scale and cheaper synthesis of active ingredient of our product and its analyses will be optimized into a set for standard operating procedure under GMP and GLP licenses from FDA. An optimized formulation will be designed for stability, materials compatibility, user friendliness, and disinfection/ sterilization capabilities to fulfill the federal efficacy and safety requirements for 510(k) notification for marketability. This will be achieved through a research done in 5 specific aims, proposed here. Based on the promising data exhibited by the active ingredient of our product in Phase I study, a US patent application has been filed. The same data also indicate that the success our product through this proposed Phase-ll study, which leads to the FDA approval against 510(k) notification, is clearly foreseen, too. This product can help contain many nosocomial infections, which affect as many as 2 million citizens and cost more than $ 4.5 millions to economy annually. Our product has a potential to eradicate the problems associated with HLD agents of today, and to capture their almost entire market.