ABSTRACT

Prior to nomination into full development, a candidate drug should undergo a phase traditionally called preformulation. Preformulation is the physicochemical characterization of the solid and solution properties of compounds and although now relatively old, the definition of preformulation proposed by Akers (1976) is particularly apt:

Preformulation testing encompasses all studies enacted on a new drug compound in order to produce useful information for subsequent formulation of a stable and biopharmaceutically suitable drug dosage form.