ABSTRACT
The drug development process involves a number of activities which are carried out simultaneously, as shown by the oversimplified depiction in Fig. 1. Once a molecule is discovered that has desirable biological activity, the process of creating a pharmaceutical drug product from this molecule begins. As toxicology and efficacy studies are undertaken, methods for manufacture of the active molecule and for its delivery in therapeutic doses are sought. Critical to the latter effort is finding a form of the active molecule which exhibits appropriate physical properties. The form ultimately selected, called the active pharmaceutical ingredient (API), or drug substance, must be stable and bioavailable enough to be formulated into a drug product, such as a tablet or suspension. This formulation must be effective at delivering the active molecule to the targeted biosystem.
