During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals. Recent advances in process control, such as the Smart Freeze-Dryer^TM technology or similar approaches, make cycle development a routine procedure.

Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying PAT in the laboratory can provide valuable information about product and process behaviour and may help to identify the critical process parameters during cycle development and optimisation.

Over the last decade, the development of new drug delivery methods and devices for dry powder inhalation, needle-free intradermal powder injection or sustained parenteral drug delivery has led to an increasing demand for powder formulations incorporating an active pharmaceutical ingredient (API).