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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.
When considering the added complexities of administration of these sensitive molecules and whether to use a traditional vial format or a combination product, drug manufacturers must consider the strategic and cost implications in the earliest stages of development. However, considering that more than half of the top 20 injectable drug products on the market today are delivered in prefilled syringes,1 there seems to be a preference towards use of prefillable syringes. The efficiency and ease of use of not needing to withdraw drug product from vials, with the benefit of significantly reducing dosing errors, spurred the uptake of unit-dose prefillable syringes. The prefillable syringe market is set to exceed USD 6.2 billion in 2023 with a compound annual growth rate of approximately 11% from 2023-2028.2 Sales of prefillable syringes have increased globally, making them a top choice for modern molecule containment.
However, the next, more critical question drug manufacturers must ask themselves is whether to choose glass or polymer syringes. While traditional glass syringes are still widely used, they are not always the best choice when dealing with the sensitive requirements of modern molecules. Certain molecules do not react well with glass and can result in drug interactions with glass packaging.
Glass syringe disadvantages include:
With the shortfalls of glass, polymer syringes are quickly gaining increased attention from drug manufacturers due to their attractive benefits. The two most prevalent polymers used in prefillable syringes are Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC). COP syringes have been the primary choice for modern molecule drugs to date,3 and are designed to overcome the deficiencies of glass syringes and protect sensitive molecules.
Daikyo Crystal Zenith® COP syringe advantages are outlined below.
Attributes that contribute to product quality:
Attributes that enhance performance:
Figure 1. Daikyo Crystal Zenith® (CZ) syringe versus Glass Particle Formation by End-Over-End Rotation of IgG Samples.
The new Daikyo Crystal Zenith® 2.25 mL Insert Needle syringe meets the needs of sensitive molecules intended for subcutaneous delivery that require larger volumes with its higher volume capacity. As drug manufacturers evaluate their packaging strategy earlier in their drug development process, the Daikyo Crystal Zenith® 2.25 mL Insert Needle syringe offers a new larger volume option to enable patient choice, as these syringes are compatible with next generation autoinjectors.
Interested in learning more about Daikyo Crystal Zenith® 2.25mL Syringes attend our upcoming webinar on August 16. Register today!
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith® syringe technology is licensed from Daikyo Seiko, Ltd.
Take an in-depth look at the science behind containment & delivery ofinjectable medicines in the West Knowledge Center.
The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.
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.
In a previous <a href="/zh-cn/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
The use of proteins as therapeutics has focused attention on the need to maintain the stability of these labile molecules during both storage and shipment. The trend in the pharmaceutical industry has been to package therapeutic proteins in prefillable syringes made of glass. However, some biologics are not stable in glass syringes due to sensitivity to adhesives used in their manufacture and to tungsten oxides generated during needle placement.