Preformulation Studies and Thermal AssessmentThe first step in lyophilization cycle development for a freeze-dried product is essentially understanding of bulk formulation solution thermal properties. Bulk solution structures’ formation during the freezing stage (amorphous or crystalline) must be critically characterized in order to define appropriate drying parameters of shelf temperatures, soak and ramps, chamber pressures, and duration of all the phases.
To achieve this, some critical temperatures should be accurately determined: freezing temperature, glass transition temperatures ( T'g and Tg), and the eutectic/collapse temperatures. Based upon these fundamental properties, operational parameters are established during experimental phase and optimized over the development phase.
Kamat possess highly sophisticated instruments such as Differential scanning calorimetry and Freeze-drying microscopy to characterize the thermal properties of the bulk solution destined for lyophilization.