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In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.
To design a suitable study, a deep understanding of every material used in manufacture, storage, shipping and delivery of the drug/biologic product is necessary. Every material, whether polymer, glass, elastomer, metal or other, has unique characteristics and requirements when it comes to potential extractables and leachables. For example, glass consists of inorganic materials, which can best be addressed using aqueous solutions and detection of the extracted elements via Inductively Coupled Plasma (ICP). Polymers and elastomers can best be addressed using aqueous and organic solvents. However, there are significant differences that must be considered.
Considering polymers, BPOG (Biophorum Operations Group) has developed extractables methods for single-use manufacturing components and systems (SUS), for example silicone tubes, connectors, filters and plastic pouches. BPOG extractables studies, and the results produced from them, are specifically designed to address conditions of manufacturing, which can be wide-ranging and are not typical of storage and delivery. In particular, solvents used, such as 1% polysorbate and extreme pH values, can produce anomalies, require dilutions or mask some extractables. Further, 50% ethanol can produce interaction products.
To enable best correlation of extractable data to potential leachables, solvents employed should be stable, resistant to degrading or dissolving components and free of interferences. In other words, every extractable study should be tailor-made. Packaging component suppliers have the deepest knowledge about their materials and are best prepared to design such studies. West Analytical Laboratory services has the staff, expertise, and facilities to design and execute such studies. For more information, contact an Account Manager or Technical Customer Service representative.
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.
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.
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.
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.”
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