Introduction
With a continued rise in demand, the market is expected to grow rapidly for ready-to-administer (RTA) pre-filled syringes with a projected potential market share of 12.8 billion with a CAGR of >12% in the next few years.1 This growth is fueled by a surge in geriatric and diabetes populations coupled with increased demands for biologics for unmet medical needs requiring a self-injectable route of administration.2
The main interest in the pre-filled syringe stems from the number of benefits, including patient accessibility and affordability, safety, reducing drug waste, and outweighing patients’ benefits over risk for health providers and drug manufacturers.3 Pre-filled syringes can deliver the solution volumes between 0.25 and 5 ml. Hence, they are best suited for administering drugs by subcutaneous (SubQ), intramuscular (IM), and intradermal (ID) injections.
Materials and Components in Pre-filled Syringes
Glass: It is derived from borosilicate glass of hydrolytic class I, stable at temperatures as high as 565o C, but is highly fragile, so care must be exercised when used. This is used as a syringe barrel, non-reactive and stable during storage.
Plastics/Polymers: They produce robust, non-fragile devices as compared to glass pre-filled syringes with better durability, biocompatibility, stability, and lightweight. They should be free of leachable and extractable to avoid any adverse effects such as carcinogenicity and immunogenic toxicity. Figure 1 shows the different parts of a pre-filled syringe, and Table 1 shows the materials used to construct the pre-filled syringes.
Glass-filled syringes have two categories – oil-siliconized syringes and baked-on silicone syringes. In oil oil-siliconized syringe system, there is direct contact between rubber with glass. Over time, that leads to higher breakout forces and possible contamination. A baked-on silicone syringe system has a consistent coating of glass barrels that leads to a lowering of breakout forces during storage. In Figure 2, A denotes the higher breakout force (F) in oily siliconized syringes and the lower breakout force (F) in baked-on silicone syringes.
Manufacturing of Pre-filled Syringes
A conventional self-filling process requires filling a syringe with a solution and capping followed by sterilization. This filling process may lead to air bubbles. To alleviate these challenges, the bubble-free method is used which involves filling and capping under a vacuum involving Hyaluron contract manufacturing technology. By eliminating the air bubbles, it improves the stability of a drug from oxidative degradation of sensitive molecules. By placing stoppers under a vacuum, more accurate filling in the pre-filled syringes is achieved.4 Table 2 shows the needle geometry and route of administrations and Table 3 shows the drugs approved in pre-filled syringes.
Conclusion and Future Perspectives
The manufacturing of pre-filled syringes involves identifying the components and processing of those materials, including filling. It must be filled aseptically in a sterile clean room with Grade A or ISO 5 laminar flow environments to prevent contamination. This is typically done with specialized filling machines designed to control pressure and temperature.
Filling is typically done in batches and must be strictly monitored to ensure accuracy. Since fill and finish process must be conducted aseptically, the maintenance of strict temperature controls, process validation, and environmental monitoring of non-viable and vial counts should be taken into consideration.
Ascendia has installed a flexible aseptic filler for prefilled syringes, vials, and cartridges within its new state-of-the-art cGMP sterile manufacturing facilities that comply with regulatory standards. Ascendia is poised to tackle the molecules in pre-filled syringes with novel formulations and aseptic processes that improve a drug’s bioavailability, efficacy, and stability over an extended period. Ascendia is ready to manufacture pre-filled syringes for immediate needs. Ascendia’s flexible filler supports batch sizes from a few units to 30,000 units/batch.
References
- R. Soikes, Moving from vials to a pre-filled syringe, Pharm. Technology, 2009 Supplement, Issue 5, 1-8.
- P. Malik, Why utilization of ready-to-administer syringes during high-stress situations is more important than ever, J. Infusion Nursing, 2022, 45, 27-36.
- C. Dubin, Special Feature- Pre-filled syringes & parenteral manufacturing: Flexibility for faster development, Drug Dev. Delivery, 2019 May
- L. Danielle, Advanced innovations on a new generation of plastic prefilled syringes. Cedar cottage, Newtimber Place Lane, West Sussex, BN6 9BU, United Kingdom: ON drug delivery Ltd; 2010.
- S. Makwana, B. Basu. Y. Makasana, and A. Dharamsi, Pre-filled syringes: an innovation in parenteral packaging, Int. J. Pharm. Invest., 2011, 1, 200-206.
Author Details
Shaukat Ali, PhD and Jim Huang, PhD- Ascendia Pharmaceuticals, www.ascendiapharma.com
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 27, No. 3April 2024Pages: 26-27
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