Selecting the Right Container System
The current global market of prefilled syringes is comprised of over two billion units per year and growing. Many chronic diseases, such as multiple sclerosis and rheumatoid arthritis, require home-based administration of injectable therapies.
Auto-injectors that include a glass syringe have been a safe and convenient delivery system, but they have notable limitations, including:
- Performance Issues
- Protein Aggregation
Any glass product runs the risk of breakage, which can lead to particulate contamination. Particulate contamination is the unintended presence of extraneous, mobile and/or undissolved particles in a therapy or parenteral solution. These particles can be of various sizes, usually only detectable by visual inspection in general greater than or equal to 50 Um or sub-visible with a range of 2-50 um, demanding specific analytical tests for their detection. Particulate contamination may cause inflammation, which can affect a patient’s brain, eyes, lungs, liver, heart, intestines, kidneys and spleen.
In addition, traditional syringe systems may include the use of silicone oil. Drug products that are contaminated with silicone oil particles can lead to certain types of lung disease (Bowen et al. 1981). While little is known about the effect of silicone oil in humans over a long period of time, it is believed that serious adverse events can occur when silicone oil comes into contact with drug proteins.
Cyclic olefin polymers, such as Daikyo Crystal Zenith® (CZ), may provide a better patient risk profile and drug delivery system. This highly break resistant material can help to avoid the issues of particulate contamination, glass breakage and silicone oil. The material also forms an excellent moisture barrier, which helps to ensure extremely low particulate levels.
The Daikyo Crystal Zenith syringe with the FluroTec® barrier film-coated piston may eliminate the risk of delays and patient safety issues that are the unintended consequences of traditional combination delivery products in use today.
For more information about the CZ syringe or other injectable solutions from West, visit our website.