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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.
The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
Drug developers must understand and mitigate the risk of various chemical entities (leachables) migrating from any material that comes into contact with their drug product. Failure to execute an appropriate extractables and leachables assessment could lead to failures in meeting agency expectations and a delay in drug development timelines.
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663><sup>1</sup> and <1664><sup>2</sup>. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
The FDA states: <em>Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* </em>While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
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