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When combined with the industry trends of increased regulatory scrutiny and higher focus on patient safety, risk management, and compliance, the market is seeing an increased need for high-quality drug delivery systems such as prefillable syringes.
Prefillable syringes have become an increasingly important option in the packaging and delivery of injectable drug products due to two major factors:
The prefillable syringe serves two major purposes.
Benefits of prefillable syringes include:
Typical Prefillable Syringe System
A prefillable syringe system is composed of the liquid drug, the syringe barrel, the elastomeric plunger, the tip cap or needle shield, the plunger rod, and depending on the application, the backstop or finger flange. The typical fill volume is 0.5mL to 5mL. Traditionally, a prefillable syringe barrel has been made from glass tubing. Syringe manufacturers typically form and process the glass. Pharmaceutical companies purchase syringes and the complementary elastomeric components (e.g., plungers, tip caps, needle shields) that complete the primary package. Prefillable syringe designs can include double chamber syringes, syringes with fixed needles, insert needle syringes, and luer lock syringes.
Polymer vs Glass Prefillable Syringe Systems
There are two major types of prefillable syringe systems:
The benefits of glass systems include:
There are, however, drawbacks:
Polymer-based syringe systems are gaining acceptance because of their benefits compared to glass systems. For example, the Japanese market has transitioned many of its syringe applications to polymer because of superior performance.
The most widely used prefillable polymer syringe systems are manufactured from cyclic olefin polymer (COP) and cyclic olefin co-polymer (COC) resin. It is imperative to understand the unique characteristics of the polymer syringe system because the package choice is critical in ensuring the long-term success of a drug product.
The benefits of polymer-based systems over glass systems include:
However there are still drawbacks, including:
Whether a glass or polymer system is right depends upon specific needs.
Prefillable Syringe Plunger Selection and Additional Components
In addition to deciding between a glass or polymer barrel there is the matter of selecting a plunger. The main requirements for prefillable syringe plungers include compatibility with glass or polymer syringe barrels, compatibility with the drug product, compatibility with gamma-irradiation or steam sterilization, and good break loose and gliding forces.
Decisions when selecting a plunger include the elastomer formulation (typically bromobutyl or chlorobutyl), the barrier film and/or coating (FluroTec® barrier film, silicone oil, or B2 coating), and the processing of the plunger (bulk, washed, or sterile). If a needle shield or tip cap is required, West has several options including rigid needle shields, soft needle shields, and tip cap designs.
Analytical Testing for Prefillable Syringes
As part of our commitment to Simplify the Journey™ for customers, West offers expert consultation and container closure integrity testing in alignment with USP Chapter <1207> Sterile Product Packaging – Integrity Evaluation. This testing is essential to help customers demonstrate prefillable syringe performance, in particular:
In addition to CCI testing, West's lab capabilities include:
The West team can assist in putting together a holistic testing plan for a prefillable syringe system.To learn more about prefillable syringe systems, click here.
FluroTec and NovaGuard are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
FluroTec and B2-Coating technologies are licensed from Daikyo Seiko, Ltd.
Prefillable syringes have become an increasingly important option in the packaging and delivery of injectable drug products. The prefillable syringe serves two major purposes for the administration of a drug. The first is as primary packaging by assuring that there is no adverse effect on the identity, strength, quality, purity or potency of the drug over its shelf life. Second, a prefillable syringe is a delivery system designed to administer the appropriate amount of the drug to the patient reliably
In an effort to treat more complex diseases, the injectables market has seen high-value molecules dominate clinical pipelines. As modern molecules continue to gain market share, it is becoming the norm for drug manufacturers to plan containment system compatibility earlier in their drug development process due to the sensitivities of their complex molecules. With packaging systems becoming an integral part of the drug development and research process, a challenge drug manufacturers face is the plentitude of choice.
Mitigate risk of contamination, enable accurate dosing, while maintaining the stability and sterility of parenteral products
Most physicians agree - of all the services that can be performed for patients, eliminating the pain and fear of injections is at the top of the list. How can pain be minimized? One approach is to maximize syringe performance - whether the syringe is employed by a clinician, in an autoinjector, or in a wearable device. A critical element of syringe performance is the break-loose force. This is the force needed to overcome the plunger inertia in a filled syringe to initiate plunger movement and introduction of drug product. A lower, more consistent, break-loose force can provide for increased patient comfort.
One of the main risks associated with drug delivery via vial containment systems is particles that can result from fragmentation and coring of rubber stoppers subjected to needle or spike punctures. This risk can be mitigated by using prefilled syringe systems, whereby the drug dosage has been filled into the syringe by the drug manufacturer. The drug dosage is then administered by subcutaneous or intramuscular injection. A prefilled syringe system generates fewer particles during drug administration, as compared to a vial containment system. Furthermore, this form of drug delivery system ensures efficiency and greater convenience.
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