Dr Heike Kofler - manager Technical Customer Support Europe at West Pharmaceutical Services explores the considerations for lyophilisation closure selection and processing to protect moisture-sensitive drug products.
Cold chain
Lyophilisation or freeze-drying is known as the removal of water from a frozen liquid product by a phenomenon called sublimation. The result is a solid, dried product inside the vial. This is an ideal process for moisture-sensitive drug products that may have a limited shelf-life due to external influences such as moisture ingress. If injectable drug formulations are unstable in aqueous solutions, due to the molecular interactions. they can degrade quickly in solution, which is why these drugs are often freeze dried. This will protect them from certain external influences and potential degradation.
Lyophilising moisture-sensitive injectables enables drug stability during their assigned shelf life until they are reconstituted into their liquid presentation prior to drug administration. An increasing number of injectables are marketed in a lyophilised form for various therapeutic indications, e.g., oncology and rare metabolic diseases.