Abstract

The objective of this article was to present some key thermodynamic and physicochemical data for the rational optimization of freeze-drying cycles. First, a ternary system of poly(vinylpyrrolidone) (PVP) + lactose + water was studied over large concentration and temperature ranges by modulated differential scanning calorimetry (MDSC). In parallel with DSC experiments, the binary system PVP + water was investigated by cryomicroscopy. Both methods showed crystallization during cooling in the PVP concentration range lower than 49% (wt) and ice recrystallization during warming in the PVP range between 49% (wt) and 64% (wt). Second, a large experimental study has been carried out to determine the influence of lactose concentration on freezable water fractions and glass-transition temperatures. Finally, the solid/liquid phase diagram of the ternary PVP/water/lactose system was determined. These new experimental data concern the melting and vitreous transition temperatures of this ternary system and could be ver...

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