West Pharmaceutical Services Inc. with affiliate Daikyo Seiko Ltd. is commercializing ready-to-use pre-fillable syringes with barrels of cyclic olefin polymer, instead of glass.
``We have an ultraclean product'' that aims to provide ``better packaging for pharmaceutical containers of the future,'' said Bernard Lahendro, West general manager and vice president for the Daikyo Crystal Zenith technologies product line and a director on Daikyo Seiko's board.
``This innovative new material will bring jobs into the United States,'' Lahendro said in a telephone interview from West Pharmaceutical headquarters in Lionville, Pa.
Daikyo, which makes specialty pharmaceutical packaging, found ways to use Crystal Zenith-brand COP for making vials and syringes, including the ready-to-use system on which joint development began in 2004. Crystal Zenith COP in a pre-filled syringe must be capable of withstanding up to two years in storage and clear major drug-stability-screening milestones.
Nippon Zeon Co. Ltd. of Tokyo manufactures Crystal Zenith and, in 1995, granted Daikyo and West exclusive global rights to use the material in pharmaceutical and medical devices.
Until now, Daikyo sold the CZ syringe components in a bulk format. The ready-to-use luer-lock syringe, which will be delivered in a tub for direct entry into an aseptic filling line, offers several advantages vs. pre-fillable glass syringes.
The global market for pre-filled syringes is about 1.8 billion units with an extremely small portion in CZ or other plastics.
The system consists of a CZ barrel, polypropylene rod, rubber-tip cap and rubber plunger.
Coatings of Daikyo-developed FluroTec barrier film are applied to the tip cap and plunger and minimize ion-extractable emissions from the polymer and adsorption onto pre-fillable syringe surfaces.
The CZ-based system avoids the need for silicone lubricants for the plunger's movement in a glass syringe and reduces the presence of suspended particles inside the syringe. Silicone oils are incompatible with some protein concentrations and can degrade a drug's effectiveness.
CZ is resistant to temperature variations and breakage.
However, the Daikyo-developed plastic syringe system is ``at least three times more expensive than pre-fillable glass'' syringes, said Vinod Vilivalam, West director of commercial development for CZ technology.
Daikyo makes CZ syringes and, for small-volume parenteral drugs, CZ vials at a Sakae, Japan, plant. For product line extensions, Daikyo is transferring the CZ high-capability manufacturing techniques to West operations in the United States.
Daikyo conveyed the CZ technology for an insert-molded stake needle syringe to West's Tech Group business segment for initial development in Scottsdale, Ariz. A Tech Group consumer plastics plant in Montgomery, Pa., will manufacture the ready-to-use syringes for North America and Europe, and a West plant in Jersey Shore, Pa., will steam-sterilize the rubber parts.
``We are trying to create an innovative proprietary product for Tech'' and are contemplating follow-on products, Lahendro said. Eventually, Tech Group also may manufacture the product line in Europe, he said.
``The plastic-based delivery system is at an early stage in its product life curve,'' said Fran DeGrazio, West vice president of marketing and strategic business development. She expects the product to hit the commercial market in 2008.
In spring 2006, West began pilot customer trials of the ready-to-use system before completing sterilization validation trials. Initial rollout is set for the Interpack trade show, being held April 24-30 in Dusseldorf, Germany. West's pharmaceutical systems business segment will market the line.
West projects the CZ effort may generate a profit by 2010 or 2011.
Vilivalam gave a briefing about pre-fillable syringe systems and Crystel Zenith COP technology during the American Association of Pharmaceutical Scientists annual meeting and exposition, which ran Nov. 11-15 in San Diego.
In 2006, West funded laboratory research on protein stability at the pharmaceutical chemistry department of the University of Kansas in Lawrence. ``Overall silicone-free CZ syringes showed a reduced extent of aggregation compared with siliconized glass syringes under the conditions examined,'' according to a study conclusion.
Publicly traded West owns 25 percent of Tokyo-based Daikyo. West and Daikyo have collaborated since 1973 and began two-way technology transfers in 1992.