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Daikyo Crystal Zenith® container systems may be your solution! Bisphosphonates are a class of drugs used to help prevent loss of bone density in diseases such as osteoporosis. This class inhibits increased loss of calcium from bones (bone resorption) by promoting apoptosis (elimination of cells absent release of harmful substances into surrounding area) of osteoclasts. Osteoclasts function to break down bone to assist with bone maintenance and to help balance blood calcium levels; however, in the case of patients with osteoporosis, there is an increased level of bone resorption that results in a need to manage and decrease the presence of the osteoclasts.
Bisphosphonates are known to react with divalent cations. When they react, they become either inactivated or have a significant loss of activation, losing their efficacy in moderating levels of osteoclasts. This reactivity with divalent cations can create a challenge for the drug innovator/manufacturer when using many pharmaceutical grade glass container systems,which can contain divalent cations, such as calcium, magnesium or barium. In such cases, the glass container will often be detrimental to the long-term stability of the drug product – resulting in the need for an alternative container or the reformulation of the drug product.
As an alternative to glass containers, Daikyo Crystal Zenith® container systems provide a solution that is free of divalent cations, enabling the long-term storage of bisphosphonate drug products. The Daikyo Crystal Zenith® cyclic olefin polymer (COP) is an engineered polymer that is used for commercial drug products of this class. Daikyo Crystal Zenith® containers are available for vial, syringe and cartridge applications. For additional information, please contact your Account Manager or Technical Customer Service Representative.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
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.
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 />
We’re excited to share that Amgen has selected West’s Daikyo Crystal Zenith® vials with FluroTec® stoppers to contain its FDA-approved therapy IMLYGIC™ (talimogene laherparepvec).
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.
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