Freeze-drying involves three basic steps—freezing, primary drying, and secondary drying—which can take several hours even several days to complete. A fundamental goal of freeze-drying is to produce a well-dried product with elegant cake appearance, short reconstitution time, long shelf life, and complete recovery of activity on rehydration, among other requirements. Two major considerations for optimization of a freeze-drying process are the stability of the drug product, during the process itself and during the storage period after the cycle is terminated. Designing an optimized freeze-drying cycle requires identifying the critical properties of the formulation so that the processing conditions can be specifically tailored to the formulation’s freeze-drying characteristics, such as the collapse temperature (Tc), glass transition temperature (Tg), and eutectic temperature (Teu).
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