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 moldedintomorecomplexshapeswithtighterdimensionaltolerancesthanglass.Additionally,plasticisnot susceptibletoglassdelamination?amajorproblemintheindustrywhereadrugproductchemicallyattacksits glasscontainer,resultinginglassfragmentsflakingoffintothedrug. Theprimarydisadvantageofplasticparenteralcontainersistheirrelativelyhighoxygenpermeability, 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 protectionofanadditionalpassivatinglayer. 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)techniquethatTriboFilmusestocreatetheoxygenbarrierlayermakeshigherqualitybarrierfilmsthan 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,TriboFilmhasdevelopedaprovenpassivatingcoatingforglassprefilledsyringeswhichwill be modified for use on barrier coated plastic containers. The passivating coating also acts as a high-?? performancelubricantforsyringes. TriboFilm'?s goal for Phase I is to create an advanced coating system for plastic parenteral containers thatprovidesoutstandingoxygenbarrierpropertiestoextendtheshelflifeofoxygen-??sensitiveproducts,and presents a surface to the drug product that, (a) is chemically inert and resistant to attack from the container'?s contents,(b)willnotmigrateintothedrugproductintheformofleachables,extractables,orparticles,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 containerformattoanotherduringthelifecycleofadrug.Thiscouldsaveacompanymillionsofdollarsin reformulationcostsandtimetomarketwhiletransitioning,e.g.,fromavialtoaprefilledsyringe.
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 moldedintomorecomplexshapeswithtighterdimensionaltolerancesthanglass.Additionally,plasticisnot susceptibletoglassdelamination?amajorproblemintheindustrywhereadrugproductchemicallyattacksits glass container, resulting in glass fragments flaking off into the drug. However, medical-??grade plastics are muchmorepermeabletooxygenthanglass,whichcanreducetheshelflifeofoxygen-??sensitivedrugproducts. TriboFilmResearch,Inc.isdevelopingabi-??layeroxygenbarrier+passivationcoatingsystemforuseonplastic parenteral containers, called TriboShield?. The TriboShield? barrier coating system is expected to outperform all existing competing products for two reasons. First, the Atomic Layer Deposition (ALD) techniquethatTriboFilmusestocreatetheoxygenbarrierlayermakeshigherqualitybarrierfilmsthancanbe 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 modifiedforuseonbarriercoatedplasticcontainers.Thus,theTriboShield?technologywillprovideaplastic parenteral container with oxygen barrier properties similar to those of glass, which will allow the pharmaceuticalindustrytoshifttothemoredesirableplasticcontainermaterial.
