ABSTRACT

Polymorphism  is a widespread phenomenon, and statistically, 85% of active pharmaceutical ingredients (APIs) exhibit (pseudo)polymorphism, and 50% of APIs have multiple forms.3 Accordingly, polymorphism investigation of new APIs becomes a regulatory and important practice in the pharmaceutical industry. Ideally, the polymorph selected in the drug development should be thermodynamically stable, with good solubility and dissolution rate prole, nonhygroscopic, with high melting temperature, compact morphology (no needles or plates), and not forming hydrates even at high relative humidity levels.