Abstract
The principal aim of this study was to provide a method for monitoring the product temperature during primary drying of the freeze-drying process of model pharmaceutical formulations from pressure rise based on the MTM method without insertion of thermocouples sensors in few vials, and establish a method for evaluating the ice front temperature and the mass transfer resistance to water vapor flux through the dried layer during primary drying. Effects of the formulation concentration, the shelf temperature and the chamber pressure on the ice front temperature and resistance to water vapor through dried layer were studied experimentally by MTM method, and the optimization program can be obtained. MTM method has been proposed as a more precise predictive way for determining the end of primary drying.
