Modeling the Desorption Stage in Lyophilization Technology of bis(N-Monosuccinyl-L-Glutamyl-L-Lysine) Hexamethylenediamide (GK-2)

Abstract

Modeling lyophilization is the most convenient approach to optimizing the drying stage because it allows the optimal temperature regime for secondary drying to be selected using a small number of experiments and the duration of the process to be calculated as a function of the conditions. A simple mixed mathematical model of the process was used because of the ability to extrapolate the data and the small number of required experiments. The dependences of the drying rate on thermal variables at a constant total pressure and of the possibility of a dynamic temperature rise on residual moisture content were calculated. The optimal secondary drying regime was determined by comparing the performance of various regimes, verifying the reproducibility of the model, and comparing theoretical and experimental values of residual moisture. The most suitable drying regime for bis(N-monosuccinyl-L-glutamyl-L-lysine) hexamethylenediamide (GK-2) lyophilizates for injection was selected.