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

Differential scanning calorimetry (DSC) is a thermal analytical tool for preformulation studies. Extrapolated melting temperature ( T _P) and heat of fusion (Δ 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 Δ H _f values and T _P 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 Δ H _f values but not the T _p values for acetaminophen. However, no significant effect was found for the T _p value but Δ H _f value was affected to a certain extent for nicotinamide. [ABSTRACT FROM AUTHOR]