TRIBOFILM RESEARCH INC — Department of Health and Human Services SBIR Phase II: NHLBI

Description

PROJECT ABSTRACTPlastic offers several key advantages over Typeborosilicate glass as a material for parenteral pharmaceutical containerse gvials and prefilled syringesPlastic is not prone to breakageand can be molded into more complex shapes with tighter dimensional tolerances than glassAdditionallyplastic is not susceptible to glass delaminationa major problem in the industry where a drug product chemically attacks its glass containerresulting in glass fragments flaking off into the drugThe primary disadvantage of plastic containers is their relatively high oxygen permeabilitywhich can reduce the shelf life of oxygen sensitive drugsBy applying a barrier coating to a plastic container that drastically lowers its oxygen permeabilitythis shortcoming can be eliminatedThe viable candidate materials from which to make this barrier coating have similar chemistries to glassand thus have similar susceptibility to chemical attackThereforethe barrier coating requires the protection of an additional passivating layerIn Phase ITriboFilm Research optimized TriboShielda bi layer coating system consisting of a highly effective oxygen barrier layer plus a protective passivation layer for plastic parenteral containersTriboShieldcoated plastic vials were shown to have oxygen barrier properties similar to those of glass vialsFurtherthe passivation layer was shown to be effective in protecting the oxygen barrier layer from common buffers used in parenteral formulationsIn additionit was shown that subjecting TriboShieldcoated plastic vials to ethylene oxide sterilization had no effect on their oxygen barrier performancePhase II will build on the Phase I findings to prove the commercial viability of the TriboShieldtechnology from a manufacturing standpointThe TriboShieldcoating 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 formulationsA high speed inspection technique will be developed to verify the presence of theinvisible to the eyeoxygen barrier coating on each container for quality assurance purposesIn additiona comprehensive study will be performed to verify the long term stability of epinephrine stored in TriboShieldcoated plastic vialsThis project will culminate with the creation of a pilot scale coating system that will demonstrate how all the steps required to deposit the TriboShieldcoating system can be integrated into a continuous manufacturing processThe pilot machine will show the knowhow for full scale manufacturing that can be transferred to potential licenseeswhile also producing TriboShieldcoated containers that can be provided to customers for evaluationDevice manufacturers and drug makers have long desired a container suitable for use with oxygensensitive drugs that is free of any concerns with breakage or glass delaminationIf successfulTriboShieldwill provide thisenabling the pharmaceutical industry to transition to more desirable plastic containers PROJECT NARRATIVEPlastic offers several key advantages over Typeborosilicate glass as a material for parenteral pharmaceutical containerse gvials and prefilled syringesit can be molded into more complex shapes with tighter dimensional tolerances than glassand it is not prone to breakage or susceptible to glass delaminationa major problem in the industry where a drug product chemically attacks its glass containerresulting in glass fragments flaking off into the drugHowevermedical grade plastics are much more permeable to oxygen than glasswhich can reduce the shelf life of oxygen sensitive drug productsTriboFilm ResearchInchas developed a bi layer oxygen barrierpassivation coating systemcalled TriboShieldwhich will provide a plastic parenteral container with oxygen barrier properties similar to those of glassallowing the pharmaceutical industry to shift to the more desirable plastic container material