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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?”
To assist customers in developing a comprehensive, risk-based approach to the evaluation of extractables and leachables, West offers its VeriSure™ packages, which are extractables data packages for its highly recommended rubber formulations, 4023/50 and 4432/50. Data were obtained in West’s GMP laboratory in Exton, PA, using multiple analytical techniques to provide a comprehensive evaluation. These data illustrate West’s vast experience with rubber formulations and extractables analysis. Combined with West’s industry experience, as well as other service offerings, VeriSure packages serve as a roadmap for a regulatory submission – enabling customers to move rapidly from extractable studies into simulation and/or leachable studies. Further, West supports customers by designing extractables studies for other formulations and materials, as well as risk assessments for extractables.
West can support customers in four critical areas, offering the assistance of its scientific staff for consultation through the evaluation process, and its laboratories for execution of the experimental process:
The VeriSure packages, along with West’s knowledge in extractables and leachables testing, make West a good choice for customers who must make data-driven decisions on extractables and leachables. West’s VeriSure packages can be attained by contacting West Technical Customer Support via the Contact Us form.
VeriSure is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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.
Pharmaceutical industry focus on issues of extractables and leachables from packaging/delivery systems began during the mid-1990’s. Since then, regulatory agencies have become more educated, and drug product formulations have become more complex, which makes the need for a robust extractables and leachables program that much more critical. 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 question is – where to start?
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.
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.
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