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Rubber components are essential for the safe containment and delivery of parenteral drug products. Many rubber formulations used in the pharmaceutical industry are based on halobutyl rubbers. Halobutyl rubbers, typically bromobutyl or chlorobutyl, are made by the halogenation of butyl rubber, which is a copolymer of isobutylene and isoprene (to a smaller extent). Key features of halobutyl rubbers that make them suitable for the pharmaceutical industry are that they typically have lower levels of extractables compared to other rubbers, and they have excellent resistance to permeation by water and oxygen.
The question is often raised as to when to choose a bromobutyl- versus a chlorobutyl-based component. The answer is – it depends. They are comparable in terms of permeability for oxygen and water. Primary differences will be found in their extractables profiles, as different compounds are employed for curing, stabilization, etc.
Given the very wide range of drug products (small molecule, biologic, gene, cell) and the very wide range of possible chemical interactions with extractables, the best approach to select the right component is through consultation with a Technical Customer Support (TCS) expert at West. Recommendations are based upon extensive product knowledge and the ability to offer tailored experimental studies (e.g., extractables and leachables) through the Integrated Solutions offering, while also keeping patient safety as the most important goal.
For more information, contact a TCS representative or Account Manager.
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.
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.
In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.
In view of patient safety and product quality, extractables and leachables assessments of pharmaceutical packaging and delivery systems have become an integral part of both development and regulatory submissions. Two crucial USP guidance chapters, USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems” have been published to guide pharmaceutical companies on the practical and technical considerations required for extractables and leachables assessment programs.
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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