ABSTRACT

Preformulation research is the necessary step that takes place between drug discovery and clinical development. In this vital phase of drug development, the physicochemical profile of the active pharmaceutical ingredient is determined and then used to plan the course of subsequent activities. One important activity is to plan a schedule of crystallization conditions in order to maximize the likelihood of finding polymorphs or solvatomorphs, since different crystal forms will likely exhibit different solution characteristics that may be either harmful or helpful toward a particular formulation.