By Derek Duncan

Published in: Lighthouse

Published on: July 1, 2022

Introduction: Lyophilization, or freeze-drying, is a process used to stabilize a pharmaceutical formulation and increase the shelf life by removing water from the drug product. During lyophilization, the drug formulation is first frozen and then the ice is removed by sublimation under vacuum during a primary drying phase. A secondary drying phase is then used to remove unfrozen water molecules at a temperature higher than that used for primary drying. Pharmaceutical freeze-drying cycles are designed to remove most of the loosely bound water and to achieve a pharmaceutically elegant cake. For biological materials, it is important to retain a high level of activity in the final product.

Advance Stability Knowledge

Would you like to see a particular publication, guidance, organization, supplier, event, or career opportunity on StabilityHub? Contact us with your suggestion!