PHARMACEUTICAL SOLID POLYMORPHISM: APPROACH IN REGULATORY CONSIDERATION

There is a renewed interest in polymorphism. This is partly due to the increased economic pressure faced by pharmaceutical companies, and the greater awareness of the effect that polymorphism may have on the bioavailability, manufacturability, and stability of the drug product, due to improved understanding, there has come regulatory recommendations with regard to polymorphism appearing in both new drug applications (NDAs) and abbreviated new drug applications(ANDAs); particularly those for solid-oral dosage forms. This review provides a perspective of pharmaceutical solid polymorphism in drug development and in regulation.