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According to the Code of Federal Regulations Title 21 Food and Drugs Part 211.94(a) Subpart E Control of Components and Drug Product Containers and Closures, drug containers must not react or add to a drug product in a way that alters the drug’s safety or quality.
Concerns related to the packaging system can include:
– Poor chemical durability
– Use of silicone lubricants and impact to product quality
– Compatibility concerns related to biopharmaceuticals
– Potential for leaching and interaction with drug products
– Drug product shifts in pH due to glass dissolution
– Reduced potency from adsorption of drug product onto glass surface
– Breakage, scratches or particles resulting from packing, transport and filling
To help assure proper package selection and avoid potential incompatibilities between product and closure systems, a screening comparison study can be completed. This typically includes an 8-week investigational study that will help manufacturers determine the best elastomer selection for their drug product.
First, a study questionnaire is completed by the manufacturer to help the selected lab gain knowledge of the drug product. From this information, a list of potentially suitable elastomeric formulations is chosen for the study.
A gross compatibility study is designed to accelerate any incompatibilities that may exist between the drug product and the potential packaging. To accomplish this, the customer must supply bulk product or placebo for testing. Processing of components is then simulated and sample vials are inverted to maximize contact between the elastomer and the drug product. Accelerated conditions are used to help speed the analysis.
A thorough analysis may include the following screening techniques:
Appropriate sample preparations for these analyses will also need to be established as part of the study.
*These screenings involve the use of a general method, which may qualitatively uncover extractables that are present. West recommends a more thorough leachable analysis be performed on the chosen closure candidate during later evaluations.
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.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
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.
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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