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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.

To ensure drug product efficacy, components of primary packaging and delivery systems must be evaluated for safety and performance. An essential aspect of this is an extractables and leachables (E&L) study. The purpose of an E&L study is to identify compounds (organic and inorganic) that may migrate from components into drug product formulations, in particular those that may put patient safety at risk.

At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”

As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.

A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry

The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization

Amy Miller and Jennifer Riter

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.