A statistical model for the optimization of DSC performance in the evaluation of drugs for preformulation studies

摘要

Differential scanning calorimetry (DSC) is a thermal analytical tool for preformulation studies. Extrapolated melting temperature (T-p) and heat of fusion (Delta H-f) can be used as parameters for optimizing the DSC performance. Two model pharmaceuticals acetaminophen and nicotinamide are used in this study. Using a factorial design for the experimental model and matrix analysis the results, the effect of sample mass, heating rate and the nitrogen flow rate were evaluated on the Delta H-f values and Tp values. Two levels for each of the procedural variables were used as a balanced experimental design with two sample sizes, two heating rates and two nitrogen flow rates. It was found that the change in the heating rate caused significant changes in the Delta H-f values but not the T-p values for acetaminophen. However, no significant effect was found for the T-p value but Delta H-f value was affected to a certain extent for nicotinamide.