Research Project
9252190
PROJECT ABSTRACT Plastic offers several key advantages over Type 1 borosilicate glass as a material for parenteral pharmaceutical containers (e.g. vials and prefilled syringes). Plastic is less prone to breakage, and can be molded into more complex shapes with tighter dimensional tolerances than glass. Additionally, plastic is not susceptible to glass delamination ? a major problem in the industry where a drug product chemically attacks its glass container, resulting in glass fragments flaking off into the drug. The primary disadvantage of plastic parenteral containers is their relatively high oxygen permeability, which can reduce the shelf life of oxygen-??sensitive drug products. This shortcoming can be eliminated by applying a barrier coating to the container that drastically lowers the container'?s oxygen permeability. The viable candidate materials from which to make this oxygen barrier coating have similar chemistries to glass, and thus have similar susceptibility to chemical attack. Therefore, the oxygen barrier coating requires the protection of an additional passivating layer. TriboFilm Research, Inc. (TriboFilm) is developing a bi-??layer oxygen barrier + passivation coating system for use on plastic parenteral containers, called TriboShield?. The TriboShield? coating system is expected to outperform all existing competing products for two reasons. First, the Atomic Layer Deposition (ALD) technique that TriboFilm uses to create the oxygen barrier layer makes higher quality barrier films than can be achieved using other barrier coating techniques. Higher quality films will have significantly lower oxygen permeability because they will have fewer cracks and '?pinholes'? in the film for oxygen to permeate through. Second, TriboFilm has developed a proven passivating coating for glass prefilled syringes which will be modified for use on barrier coated plastic containers. The passivating coating also acts as a high-?? performance lubricant for syringes. TriboFilm'?s goal for Phase I is to create an advanced coating system for plastic parenteral containers that provides outstanding oxygen barrier properties to extend the shelf life of oxygen-??sensitive products, and presents a surface to the drug product that, (a) is chemically inert and resistant to attack from the container'?s contents, (b) will not migrate into the drug product in the form of leachables, extractables, or particles, and (c) is an effective lubricant, allowing a prefilled syringe incorporating the system to be used without any additional lubrication. When successful, the TriboShield? technology could be applied to vials, prefilled syringes, or any other plastic container, offering seamless transition for a pharmaceutical company from one container format to another during the life cycle of a drug. This could save a company millions of dollars in reformulation costs and time to market while transitioning, e.g., from a vial to a prefilled syringe.
