Advanced polymers, because of their high costs, miss some opportunities to replace glass in prefillable syringes. But numerous plastics-related developments are making inroads in the market.
West Pharmaceutical Services Inc. of Lionville, Pa., and its affiliate Daikyo Seiko Ltd. of Tokyo, produce prefillable syringes featuring Daikyo's Crystal Zenith-brand cyclic olefin polymer [COP] barrels, polypropylene rods, rubber-tip caps and rubber plungers.
West delivers a ready-to-use, luer-lock syringe in a tub for direct entry into an aseptic filling line; a ConfiDose disposable auto injector; and soon, alternative sizes of syringes in a plastic nest-and-tub format.
West is ramping up principal ConfiDose production at its Tech Group unit in Tempe, Ariz.
Another plastic product, the BD Sterifill prefillable syringe system from Becton, Dickinson and Co. of Franklin Lakes, N.J., uses a crystal-clear polymer based on COP technology.
Gerresheimer Bunde AG of Bunde, Germany, markets COP ready-to-fill syringes under the RTF trademark. Taisei Kako Co. Ltd. of Osaka, Japan, injection molds the syringes for Gerresheimer and distributes them in Asia.
Schott AG of Mainz, Germany, uses an advanced COP to produce glasslike containers for drug delivery and diagnostics. A Schott pharmaceutical packaging facility in Lebanon, Pa., is expanding its product line and production capacity, adding a full line of ready-to-fill syringe products to its portfolio of vials and cartridges.
Baxter Healthcare Corp. of Round Lake, Ill., a subsidiary of Baxter International Inc., markets Clearshot-brand copolymer prefilled syringes.
Other types of COP exist in the market, but nothing “competes with our silicone-free syringe system, which is fairly unique,” said Graham Reynolds, West's vice president of innovation strategic marketing. “We offer a complete system to the customer, and we have partnerships with filling companies to get product to market in prefillable syringes.”
Nippon Zeon Co. Ltd. of Tokyo manufactures the COP and has granted Daikyo and West exclusive global rights to use the material in pharmaceutical and medical devices.
West is starting with a stake needle version, Reynolds said in a telephone interview.
“For many years, West has been the leader in the field of elastomeric closures for inject-able drug packaging such as vials and prefilled syringes, and is now expanding its capabilities for the supply of vials and prefillable syringes manufactured from [Crystal Zenith] material,” he said.
“This [COP] material, and the systems created from it, offer significant advantages to pharmaceutical and biotech customers, including the ability to provide the only silicone-free prefillable syringe system,” Reynolds said.
He noted that the West system provides chemical inertness and mechanical performance without the need for siliconization of the syringe. “Silicone has been shown to cause problems of protein aggregation,” he said.
Many drugs on the market use Crystal Zenith, especially in Japan, the United States and Europe, Reynolds said. The market is conservative, with numerous products undergoing stability, cleanliness and other phases of testing, he said.
“There is a trend toward plastic for certain applications,” Rey-nolds said. “A lot of people think of plastics as polyethylene and polypropylene at lower costs.
“Some of the newer products like [Crystal Zenith] work with polymer manufacturing to make it suitable with low extractables and permeability.”
In July, West acquired the drug- delivery-device assets of French medical-device firm Plastef Investissements SA for an undisclosed price.
“We gained some novel technologies around needle safety device for prefilled syringes,” Reynolds said.
Production of the éris-brand safety dosing system for prefillable syringes continues at Plastef's plant in Osny, France, with the ability to use either Crystal Zenith or glass.
The compatibility of COP with advanced biotechnology drugs drives the demand toward plastic in a glass-filled market, said Bill Martineau, senior health-care analyst with Freedonia Group Inc. in Cleveland.
“A drug can interact with coatings or glass itself and potentially contaminate the drug,” he said. Often, the coating is silicone, he added.
Martineau estimates COP units account for about 15 percent of the global market for prefillable syringes, with glass used for the remainder. On a percentage basis, plastics will grow faster than glass from the smaller base, he said.
The demand percentage for COP prefillable syringes in China exceeds the global figure, Martineau said, and Western Europe has a more mature market than the U.S. for COP technology.
With regulatory filings and equipment requirements, changing to plastic syringes from traditional glass is costly, and that will slow the transition, he said.
New generic drugs are likely to be delivered in glass vs. plastics syringes, unless regulatory processes speed up in the U.S. and overseas, Martineau said.
Freedonia has estimated that global demand for all prefillable syringes was $2.1 billion in 2008. By 2018, that's expected to increase to $5.2 billion.
The firm projects global demand for all pharmaceutical packaging to rise 5.3 percent year over year to more than $47 billion in 2013.
“The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being,” said a recent industry report from consultancy Greystone Associates of Amherst, N.H.
“Now, this segment is evolving in response to changing patient populations, new classes of powerful therapeutic drugs and health-care administration initiatives,” the Greystone report said.
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