ABSTRACT
Preformulation is a critical phase in drug development where the physicochemical profiling of the active pharmaceutical ingredients (APIs) and excipients are determined and prototype formulations are made. The performance of a solid dosage form is dependent on the physicochemical properties of the active ingredient and the excipients. It is at this crucial stage, usually preceding the phase I clinical formulation, that suitable excipients are identified. Concomitant with the choice of excipients is an exhaustive evaluation of drug-excipient interaction and compatibility. The goal is to eventually prevent unnecessary and very costly changes involving time and overall development cost in subsequent steps. The process is part of what the Food and Drug Administration (FDA) refers to as quality by design, in which quality is built into the product and not added. The ultimate goal is to identify the critical properties that are considered important in the formulation of a stable, effective, and safe drug delivery system or dosage form.
