Silicone-Free Low Friction Coating for Syringes

本建议书概述了成功取得商业资格的最后步骤， 摩擦滑行在第一阶段和第二阶段开发的注射器和医疗器械用高性能非硅润滑剂系统。应用于一次性玻璃透明COG注射器的非硅酮润滑剂系统的监管批准的实现将为许多制药公司打开大门，将其昂贵的蛋白质/肽药物以注射器形式并入，而不会遇到与注射器中硅酮润滑剂迁移相关的传统污染和颗粒问题。医院和制药公司将不再需要丢弃“浑浊”的溶液，也不必担心硅胶润滑剂会干扰现场的药物性能。Tribo-Glide的商业化？高性能润滑剂系统将消除硅润滑注射器的“粘滑”问题，这些问题通常会导致医院中的注射泵报警和关闭。而且，消除这种“不平稳”的注射器运动估计在手动填充注射器中的药剂期间节省20-30%的药物。此外，Tribo-Glide？润滑系统将使医生在所有医疗环境中更精确地给药和抽血。Tribo-Glide初次鉴定后？润滑剂体系几家药品包装和制药公司急于将这一发展用于它们的新一代药物，这些新一代药物对目前99%的商业注射器中使用的硅酮润滑剂所引起的迁移问题非常敏感。

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.