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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.
Greater scrutiny is paid to the interaction between the drug and its container closure system. Drug stability over the shelf life, particulate burden, the prevention of breakage and ease of delivery are some important factors to consider. In addition, regulatory agencies and pharmaceutical companies have increased quality expectations in an effort to enhance patient safety.
High-quality cyclic olefin polymers (COP) such as the Daikyo Crystal Zenith® syringe systems, are designed to overcome challenges of glass syringes and to add value to sensitive biologics. This includes the absence of silicone oil in Daikyo Crystal Zenith syringes, which results in decreased interaction with the drug product and enhanced cleanliness. Through break resistance, superior functional performance, highly reduced extractables and leachables, and the availability of many sterile formats, polymer syringes present attractive benefits that are gaining increased attention from manufacturers seeking new answers to growing drug delivery and administration challenges.
Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.
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 containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.
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.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
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.