Research Project
9765366
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 not 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 containers is their relatively high oxygen permeability, which can reduce the shelf life of oxygen-sensitive drugs. By applying a barrier coating to a plastic container that drastically lowers its oxygen permeability, this shortcoming can be eliminated. The viable candidate materials from which to make this barrier coating have similar chemistries to glass, and thus have similar susceptibility to chemical attack. Therefore, the barrier coating requires the protection of an additional passivating layer. In Phase I, TriboFilm Research optimized TriboShield?, a bi-layer coating system consisting of a highly effective oxygen barrier layer plus a protective passivation layer for plastic parenteral containers. TriboShield? coated plastic vials were shown to have oxygen barrier properties similar to those of glass vials. Further, the passivation layer was shown to be effective in protecting the oxygen barrier layer from common buffers used in parenteral formulations. In addition, it was shown that subjecting TriboShield? coated plastic vials to ethylene oxide sterilization had no effect on their oxygen barrier performance. Phase II will build on the Phase I findings to prove the commercial viability of the TriboShield? technology from a manufacturing standpoint. The TriboShield? coating parameters will be optimized using scalable processing equipment to achieve extremely low oxygen permeability and little to no susceptibility to chemical attack by common drug formulations. A high-speed inspection technique will be developed to verify the presence of the (invisible to the eye) oxygen barrier coating on each container for quality assurance purposes. In addition, a comprehensive study will be performed to verify the long-term stability of epinephrine stored in TriboShield? coated plastic vials. This project will culminate with the creation of a pilot-scale coating system that will demonstrate how all the steps required to deposit the TriboShield? coating system can be integrated into a continuous manufacturing process. The pilot machine will show the know- how for full-scale manufacturing that can be transferred to potential licensees, while also producing TriboShield? coated containers that can be provided to customers for evaluation. Device manufacturers and drug makers have long desired a container suitable for use with oxygen- sensitive drugs that is free of any concerns with breakage or glass delamination. If successful, TriboShield? will provide this, enabling the pharmaceutical industry to transition to more desirable plastic containers.
