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June 27, 2013
High-Quality Components Help Reduce Extractables in PFS Systems
As biologic drug products become more complex, issues around stability and preservation have forced pharmaceutical manufacturers to seek out new ways to ensure stability of the drug product and ease of injection. Second-generation biologics may have more protein concentration, and adding a solvent can help to ensure that the product is stable in liquid form.
Because complex biologic drug products are often difficult to stabilize in liquid form, solvents such as DMSO and NMP can be used to help concentrate and stabilize the drug product as a liquid. However, these solvents can cause issues with extractables and may solubilize silicone in prefilled syringes, causing issues with functionality.
High-quality components with a barrier protection such as FluroTec® film can help reduce extractables when used within a prefillabe syringe system. Novel materials for syringe barrels, including the Daikyo Crystal Zenith® cyclic olefin polymer, that do not require silicone may be an excellent choice for drug products that require solvents for stability. The silicone oil used in syringes currently on the market can transfer to the drug product, a cause of protein aggregation and a possible source of immunogenicity risk, which can lead to product returns and potential patient safety issues.
West’s insert needle syringe system, manufactured from Daikyo Crystal Zenith polymer, is a silicone-free system that is ideally suited for packaging and administering large-molecule biopharmaceuticals. The system can:
- Help keep packaged drugs pure by reducing exposure to extractables and silicone oil, which minimizes potential leachables in the drug product
- Reduce the risk of protein aggregation caused by silicone oil in the drug product
- Provide consistent piston release and travel forces
- Reduce adsorption and improve drainability
- Help reduce returns and in-process clean-ups caused by broken glass
- Eliminates issues related to delamination and contamination from glass particulate
The Crystal Zenith prefillable syringe system includes a piston and nozzle cap with Daikyo Flurotec® barrier film on the drug contact surfaces. Flurotec film provides an effective barrier against organic and inorganic extractables and it imparts lubricity, so there is no need to apply free silicone oil to the syringe barrel or piston to enhance the syringe system’s functionality.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Flurotec Closures® is a registered trademark of Daikyo Seiko, Ltd. in Japan.
Daikyo Crystal Zenith® and Flurotec technologies are licensed from Daikyo Seiko, Ltd.
