Extractables Why should we care about them
An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product.
History shows the lack of understanding in the extractables of a drug’s packaging may lead to issues down the road such as interference in drug product, increased toxicity, formation of precipitates or reduced API concentration. Extraction studies should be performed under exaggerated conditions on the final components intended for use. Why is this? The extractables profile can be affected by any changes to the components, including: washing, sterilization, addition of coatings or films, age and the intended storage conditions.
West has many years of experience designing and performing extraction studies on pharmaceutical packaging along with a good understanding of what can impact the extractable profile. Using this experience, West developed a comprehensive package for two rubber formulations that takes into account many of the variables that need to be considered when performing extractable studies. The VeriSure® technical package is based on the knowledge of West’s 4432 and 4023 rubber formulations obtained over years of substantial testing. The VeriSure technical package examines a wide range of configurations, coatings, processes, manufacturing sites, and shelf life utilizing a larger sample size than an individual component study. This package is a living document that can be used as first-pass extractables data in lieu of performing multiple studies on multiple components within the same formulation.
Extractables should be considered proactively and understood early in the development process. The VeriSure technical package can assist in this part of the process. Please contact West Technical Support for more information regarding this package and how it can work for your drug product.
VeriSure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.