Inert Plastics Advance
High-performance polymers are promising alternatives to glass for packaging sensitive drugs and diluents in parenteral systems. Drug firms are engaged in stability testing of small-molecule and biological drugs in cyclic olefin containers, industry sources report. Commercialized solutions are emerging.
Aseptic Technologies (AT) (Embolus, Belgium), a subsidiary of GlaxoSmithKline Biological (Rixensart, Belgium), is using cyclic olefin copolymer (COC) from Topas Advanced Polymers (Florence, KY) in vials to package active drug ingredients.
AT has supplied a clinical line for filling 3000 vials per hour to a contract packager in the United States, and it will soon deliver to GSK Biologicals a production line for turning out 36,000 vials an hour, AT has announced.
Cosmetic applications increasingly use new vial polymers. Courtesy Zeon Chemicals.
The application is the first use of COC in vials made for vaccines, says Barbara Canale, market development, Topas Advanced Polymers.
In AT’s Crystal filling technology, vials are supplied closed and irradiated. The pharmaceutical product is filled into the vial through a noncoring needle that pierces an elastomeric resealable stopper port. The stopper is then resealed with a laser.
Rexam, at its Neuenburg, Germany, facility, supplies the injection-molded vials assembled in ISO 5 cleanroom condition, ready for filling.
Canale says use of COC in the aseptic process provides better sterility assurance by minimizing particulates. The use of gamma-sterilized ready-to-fill vials eliminates washing and sterilization tunnels to reduce costs and provide silicone-free closure integrity.
COC met material quality and processing requirements, the companies said. “Topas is ultrapure and biocompatible, has a very high moisture-barrier effect, and is resistant to damage by many chemical substances. Moreover, the polymer material provides high transparency, and greater [breakage] resistance than glass,” says Canale.
“The drug’s purity is preserved because COC is biologically inert, with very low extractables. Ion release that can occur with glass is eliminated, so pH is controlled within U.S. Pharmacopeia limits. Using COC also provides cost savings in that it eliminates the need to overfill to offset drug adhesion to container walls,” she adds.
Cyclic olefin polymer (COP), sold under the Zeonex trade name, provides similar advantages in an inert plastic, with the added benefit of being less brittle and allowing for more-complex shape and size containers than COC, says Brian Cail, manager for new business development, Zeon Chemicals (Louisville, KY).
Lyophilized vials from Zeon Chemicals provide clarity and thermal resistance.
Cail says firms launching drugs in lyophilized form are exploring COP as an alternative for syringes and vials.
“Many of the newer bio-drugs are coming out in lyophilized form at least for the initial launch to address drug stability concerns. COP addresses the pH shift issues in common glass. Its low water absorption makes it an ideal material for keeping the lyophilized drug free of moisture during storage. People are testing COP as a glass alternative in these applications,” says Cail.
Zeon Chemical has three grades of Zeonex that are USP Class VI; the grades differ in their thermal resistance. The COP polymer has been most successful in syringes for contrast media, given its clarity, and mechanical toughness that supports molding of larger devices. “We are seeing a lot of interest in cosmetic filler applications, designed to compete with Botox,” says Cail.
“These are high-viscosity inert fillers with numbing agents that require excellent compatibility with the numbing agent, strength required for injection, and high transparency for viewing how much is injected,” he adds.
West Pharmaceutical Services is introducing a 1-ml luer-lock syringe made of the proprietary Crystal Zenith COP resin in a sterile ready-to-use format that will work with customers’ aseptic filling processes. Daikyo manufactures and 100% vision inspects the syringe components, and West is responsible for assembling, nesting and sterilizing the systems. West has small-volume sample capacity at a facility in Montgomery, PA, says Fran DeGrazio, vice president of marketing and strategic business development, West Pharmaceuticals.
“The CZ 1-ml syringe can go right to customers’ filling lines, in a ready-to-fill format that makes it acceptable to U.S. and European customers. As a silicon-free system, the CZ syringe is optimal for sensitive bio-pharma products,” says DeGrazio. Syringe function is facilitated by the barrel design and Daikyo’s Flurotec laminate coating on elastomeric components.