Characterization of Hydration/Solvation Chakactekistics of Azelastine Hydrochloride

Abstract
Azelastine hydrochloride, an investigational drug, was observed to form a hydrate or solvates upon recrystallization. X-ray diffraction and thermal analytical studies indicate that the hydrate or solvates exist in crystalline forms different from that of the parent material. Thermal analytical techniques confirmed that azelastine forms hydrate or solvates as opposed to a polymorph. The enthalpies and entropies of transitions were determined. A difference in dissolution rate of unrecrystallized and recrystallized azelastine was found.