Quantitative correlation between initial dissolution rate and heat of fusion of drug substance.

The initial dissolution rates of amorphous, partial crystalline and crystalline samples of terfenadine polymorphs (forms I and II) were measured by the rotating disk method. The heats of fusion due to crystalline fraction of samples were obtained by the differential scanning calorimetry (DSC) data taking into account the heat of crystallization and the heat capacity change at glass transition during the heating process. The logarithms of initial dissolution rates of different crystallinity samples were linearly correlated with the corrected heats of fusion, irrespective of the crystal forms.