Silicone-Free Low Friction Coating for Syringes

本提案概述了实现成功的商业资格的最后步骤 Tribo-Glide？在第一阶段和第二阶段开发的用于注射器和医疗器械的高性能非硅润滑油系统。监管部门批准适用于一次性玻璃透明COG注射器的非硅润滑剂系统的成功，将为众多制药公司打开大门，使其能够将昂贵的蛋白质/多肽药物以注射器的形式并入，而不会遇到与硅酮润滑剂在注射器中迁移相关的传统污染和微粒问题。医院和制药公司将不再需要丢弃“混浊”的解决方案，也不再担心硅胶润滑剂会干扰该领域的药物性能。摩擦式滑翔机的商业化？高性能的润滑剂系统将消除硅胶润滑的注射器经常导致注射器泵报警和在医院关闭的“粘滑”问题。此外，据估计，在手动将药物填充到注射器中的过程中，消除这种“抖动”的注射器运动可以节省20%-30%的药物。此外，Tribo-Glide？润滑剂系统将使医生在所有医疗环境中更精确地给药和抽血。在Tribo-Glide的初步资格之后？润滑剂系统几家药品包装和制药公司急于将这一开发用于他们的新一代药物，这些药物对目前的硅酮润滑剂造成的迁移问题非常敏感，目前99%的商业注射器都使用硅酮润滑剂。

This proposal outlines the final steps in achieving the successful commercial qualification of the Tribo-Glide? high performance non-silicone lubricant system developed in Phase I and Phase II for syringes and medical devices. Achievement of regulatory approval of the non-silicone lubricant system applied to disposable glass-clear COG syringes will open the door for numerous drug companies to incorporate their expensive protein/peptide drugs in syringe format without encountering the traditional contamination and particulate problems associated with silicone lubricant migration in syringes. Hospitals and pharmaceutical companies will no longer have to throw away "cloudy" solutions or concern themselves with silicone lubricants interfering with medicant performance in the field. Commercialization of the Tribo-Glide? high performance lubricant system will eliminate the "stick-slip" problems found with silicone lubricated syringes which routinely cause syringe pumps to alarm and shut down in hospitals. Also, the elimination of this "jerky" syringe movement is estimated to save 20-30% of the drug during manual filling of the medicant in the syringe. In addition, the smooth gliding performance of the Tribo-Glide? lubricant system will make administering drugs and drawing blood more precise by the practitioner in all medical environments. Upon the initial qualification of the Tribo-Glide? lubricant system several pharmaceutical packaging and drug companies are anxious to utilize this development with their new generation drugs that are very sensitive to the migration problems posed by current silicone lubricants which are employed in 99% of all commercial syringes.