Prefilled syringes are syringes that come pre-filled with a specific dose of medication. They offer several advantages over traditional drug delivery systems (such as vials and syringes), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. It is worth highlighting that, prefilled syringes are preferably being used in the delivery of injectable drugs, especially in the treatment of chronic diseases (requiring repeated administration of the medications); various combination products have been approved / are currently under development for a myriad of therapeutic areas, such as autoimmune disorders, blood disorders, infectious diseases and ophthalmic disorders. Further, prefilled syringes are being manufactured in different capacities, based on the requirements of stakeholder / end users in this domain.
Notably, the integration of autoinjectors with prefilled syringe provides a user-friendly and convenient drug delivery product; examples of such products include Companion® Staked Needle Syringe (Credence MedSystems), Gx® Prefillable Luer Lock Glass Syringe (Gerresheimer) and syriQ™ Staked Needle Syringe (SCHOTT AG).
Classification of Prefilled Syringes
Prefilled syringes can be classified into different types, based on different parameters, such as barrel material, type of needle system, number of chambers and usability of syringe.
1. Classification Based on Barrel Material:
Glass Prefilled Syringes: Majority of the current prefilled syringes are fabricated using glass, owing to its excellent barrier properties, that prevent oxygen and water vapor from interacting with the stored drug. Further, glass prefilled syringes are compatible with various filling equipment and enable easy integration with the operations of the pharmaceutical firms. These syringes also have low risk in supply chain and streamlined regulatory process (when compared to other materials). However, these syringes are associated with certain limitations, such as fragile nature, leaching of extractables, high manufacturing cost and heavy weight.
Plastic Prefilled Syringe: Plastic prefilled syringes are fabricated using different types of polymer materials, including cyclic olefin polymer (COP), cyclo olefin co-polymer (COC), polypropylene, polyethylene and polyethylene terephthalate. These syringes offer various benefits, including wider design options, enhanced robustness, increased stability and reduced risk of breakage.
2. Classification Based on Type of Needle System:
Staked Needle System: In this system, the needle is manufactured as a part of the syringe, and is not detachable.
Luer Cone: In this system, a tapered, conical connection is there between the needle and syringe; further, the needle in this system can be detached using a twisting motion. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.
Luer Lock: In this system, a threaded connected is there between the needle and syringe; further, the needle in this system can be detached using a screwing motion. Notably, the luer lock system creates a more secured and lead-proof connection.
3. Classification Based on Number of Chambers:
Single Chamber: A single-chamber prefilled syringe comprises of one compartment for storing and delivering the medication. It is typically used for drugs that do not require reconstitution or mixing of multiple components prior to administration.
Dual Chamber: A dual-chamber prefilled syringe comprises of two separate chambers or compartments within a single syringe body; each compartment contains a different drug component or substance. The primary purpose of the dual-chamber prefilled syringe is to enable the mixing and delivery of two or more drugs just prior to administration, for instance lyophilized powders that need to be mixed with a liquid diluent.
4. Classification Based on Usability of Syringe:
Disposable: A disposable prefilled syringe is designed for single use only and is discarded after the medication is administered. These syringes offer several advantages, including convenient use, affordability, enhanced safety, and elimination of cleaning and sterilization steps.
Reusable: A reusable prefilled syringe is a type of syringe that can be refilled and reused multiple times. These syringes reduce the medical waste that is generated due to the disposal of disposable syringes. However, they require adequate cleaning and sterilization before reuse, thereby increasing costs.
Advantages of Prefilled Syringes
Prefilled syringes are a key innovation in parenteral packaging domain and are a popular choice for drug delivery, due to their various advantages.
The different advantages of prefilled syringes have been briefly described below:
Ease of Use: Prefilled syringe make injections process easier (for both doctors and patients) as there is no requirement of manual drawing and measuring of drugs, before administration into the body.
Reduce Dosing Errors: These syringes with pre-measured dosage can reduce dosing errors and ensure accuracy in administration of medications.
Minimize Drug Waste: Prefilled syringe minimize drug waste, as the exact amount of a deliverable dose is contained in the syringe, unlike vial systems.
Reduce Risk of Contamination: Since the product is sealed at the production facility, the chances of microbial contamination are reduced significantly. This is extremely important for injectable medications.
Home use and Self-Administration: Prefilled syringes are convenient for home setting and have the potential to improve compliance by the patients.
Patient Safety: Some prefilled syringes are integrated with safety features in order to prevent inadvertent needle stick injuries.
Eliminate Overfills: Prefilled syringes eliminate the overfilling of drugs in the delivery system, thereby saving the expensive formulations.
Long Shelf Life: Since the drugs stored in prefilled syringes are safe from exposure to environmental factors, they tend to have a longer shelf life.
Advancements in Prefilled Syringes Domain
Prefilled Flush Syringes:Prefilled flush syringes play an important part in the healthcare domain; these syringes are filled with a sterile solution and are used in flushing the feeding tubes and intravenous (IV) lines. Further, they are useful in clearing blockage and maintain proper delivery of fluids and medications.
Contrast Agent Prefilled Syringes: Contrast agents are among the four high-risk groups of medicines, which are used in radiology and can harm the patients. Some of the errors that could occur with their use include administration of wrong drug, drug omission and wrong dose. These occur because of the lack of radiologist’s involvement, procedures performed by radiographers under poorly defined standing orders, and preparation and administration of contrast agents by unqualified helpers. The use of prefilled syringes for delivery of contrast agent offer several advantages, such as less loading and setup time, reduction in microbial contamination and prevention of possibility of life-threatening air embolism.
Prefilled Safety Syringes: Prefilled safety syringes are designed to provide a safe and convenient method for drug administration, particularly for healthcare workers and patients, who need to self-inject medication. These syringes either comprise of add-on safety components (that shield the needle) or are designed in such a way that the needle retracts post injection.
The use of prefilled syringes is expected to increase over the coming decades, due to the wide range of benefits offered by them, including simple design, suitability for home use, reduction in product wastage and enhanced dose accuracy. Further, innovations / advancements in prefilled syringes is likely to enhance operation, support increased automation of the fill/finish line, and boost productivity and output. In order to meet the growing demands of the clients and stay ahead of the competition, many players in the prefilled syringe domain are even expanding their production facilities and capacities.