Extractables and Leachables Testing

With such a wide variety of dosage forms, delivery systems and innovative primary packaging, there are many complications to consider when ensuring stability in the primary packaging. Where possible, MedPharm ensures these considerations are made early on in the formulation development process to avoid issues later on.

MedPharm has much experience in using anything from aluminium or PE pharmaceutical grade tubes to meter dose aerosols and more complex metered dose inhalers.

A formulation can interact with its packaging, resulting in the migration of substances from the packaging into the drug product. This can also result in new toxic/reactive substances being created. A thorough risk and safety assessment needs to be conducted and assays developed to identify and detect possible migratory substances in the formulation. These assays are bespoke to the API, formulation, packaging and conditions of use.

As well as extractable substances, it is possible to test for substances that have leached from the formulation into the packaging (leachables).

A toxicological assessment will be made on any migratory substances identified and alternative, more inert or compatible packaging can then be selected as necessary, with MedPharm expert guidance.