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.
