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Tibor Hlobik, Director, Prefillable Solutions and Technologies Growth in biopharmaceutical therapeutics is leading innovation with prefillable syringe systems. These complex sensitive drug products require highly inert primary packaging materials for improved stability and delivery in perfect quality for reduced safety risk. This poster will provide a quality comparison of primary prefillable syringe options including glass, coatings/laminates and cyclic olefin polymers, and highlight the findings of a case study comparing 1mL long syringe attributes.
Mike Gills, Customer Technical Support Process Engineer
In the case study, syringes were 100% inspected and classified for visual defects. Filled syringes were measured for quantitative particulate levels (including visible and sub-visible), and subjected to simulated transportation conditions.
Syringes made of glass or plastic contain visual defects that are associated with forming and handling. However, Daikyo Crystal Zenith® syringes showed significantly fewer defects than glass, and there was no incidence of broken flanges, a major defect, as compared to glass. It can be expected that when used for pharmaceutical drug product packaging, Daikyo Crystal Zenith syringe technology can offer a reduced level of incoming rejects and end-of-line rejects associated with 100% inspection, and minimizes the risk associated with the cost of poor quality.
Particulate matter in injectable drug solutions consists of extraneous mobile undissolved particles, other than gas bubbles, unintentionally present in solutions. Both glass and plastic syringes can contribute particulate to filled solutions in subvisible and visible size ranges. On average, filled syringes increase in particle loads after transportation simulation. However, Daikyo Crystal Zenith syringe technology contributes significantly less particulate to filled solutions as compared to glass in both pre- and post-transportation conditions, and is expected to reduce particulate contribution to drug products.
For more information on this study, read the scientific poster.
Daikyo Crystal Zenith® is a registered trademarsks of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
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.
As global healthcare systems become more heavily reliant on radiopharmaceuticals for diagnostics and treatment, ensuring that the radioactive drug is safely contained for the duration of its shelf life has never been more vital.<br />
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.
In Part I of this two-part series, several of the challenges with USP<789> <em>Particulate Matter in Ophthalmic Solutions</em> were discussed. Namely, the limits were established before routine intravitreal injections existed and the same acceptance criteria are applied to two different particle detection methods with different capabilities. Other challenges include the mismatch between required analysis volume and the very small fill volumes of ophthalmic injections and the lack of translatable limits for the syringe system alone. Regardless of the potential gaps in the pharmacopeial chapter, it is nevertheless clear that for ophthalmic injections, the industry expectations are to strive for the lowest possible visible and subvisible particle levels that are achievable.
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