We propose the development of an innovative low friction coating for elastomeric materials commonly used in medical devices. Lubricants are critical to the function of syringes and automated pharmaceutical filling lines using rubber components. Currently the only viable lubricant is a silicone oil, polydimethyl siloxane fluid. This oil can be a residual contaminate in the drug delivery system in both injectable packaged drugs and syringes. Because of the uncertainty of the toxicity and regulatory issues raised by the silicone breast implant controversy, there has been an industry wide interest in finding an alternative to silicone oil as a lubricant for medical devices. Preliminary studies have demonstrated the effectiveness of our coatings in providing lubricity without detriment to sealing, coring, or other properties of the stopper. The coatings also demonstrated barrier properties that prevent extractable rubber components from leaching into the drug. Our proposed coating will not contain silicone or elemental Si, to meet the requirements of the marketplace. These coatings are seen as a feasible alternative to silicone oil lubricants used in pharmaceutical closures for serum and lypophilized drug vials, hypodermic syringes, and inhaler valve seals.
Our market studies have found that the pharmaceutical stopper market is 2 billion stoppers per year worldwide and 1.1 billion in the US alone. An acceptable alternative to silicone oil will produce an initial demand of 100 million coated stoppers a year.
