The recent spike in market recalls for injectable drug products due to visible flaky particles associated with ‘glass delamination’ demonstrates the need to solve these problems. It is important for both drug product and container manufacturers to understand the underlying mechanisms, to test for the potential risk, and to control drug container interactions to provide patients with safe medicine.
The recalls span multiple types of drugs, buffers, containers, and age of product on the market, demonstrating that this is a multi-factorial root cause problem. The good news is that there are multiple commercial packaging solutions from various manufacturers available to solve this problem, along with the drug formulation changes that (theoretically) can be made. But due to the lack in response time of the ‘delamination’ appearance, it is urgent to have tools on hand which give a quick confirmation about potential risks of the chosen drug-container combination.
Download this article, first published in the January 2012 edition of the PDA Letter, to find out more.