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West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
The Handbook offers a practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products, including metered dose inhalers, dry powder inhalers and nasal spray. Such products pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. The Handbook offers a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry.
Chapters where West authors contributed include:
For more information or to purchase a copy of the Handbook, visit: http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470173653.html
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.
Diane Paskiet will speak at the U.S. Pharmcopeial Convention’s “Suitability and Compatibility for Packaging and Delivery Systems: Extractables and Leachables” Conference, which will be held at USP Headquarters in Rockville, Maryland, on December 9-10, 2013.
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.”
Synthetic rubber has replaced natural rubber in many fields over the past decades. Very notable are the synthetic halobutyl rubbers used as a base for pharmaceutical elastomer components. They are an excellent choice due to their attributes of low permeability to air and moisture, excellent aging resistance, and low level of extractables. Halobutyl rubbers are available in two types, chlorobutyl and bromobutyl; both can be manufactured by co-polymerization with halogenated monomer.
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