Simon Cote

Principal Technical SME, Seals, TCS

March 07, 2018

Challenges with bisphosphonates adversely interacting with glass container systems?

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.

Daikyo Crystal Zenith Vials and Syringes

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.