**1. Introduction**

Discovery of a new drug entity is a huge milestone in science and it becomes even more important if it passes toxicity screening as the potential benefits overweigh the side effects. The ultimate effect of the new chemical entity depends on its availability at the site of action once it is administered through appropriate route in appropriate form. So for this reason, a new challenge is offered after successful pharmaceutical and toxicological screening that is to transform potential active new drug entity into a pharmaceutical formulation. It can be broadly elaborated as "a phase which works on study of physical, chemical, analytical, pharmacokinetic, and pharmacodynamic properties of new chemical entity and utilize the obtained results to design and develop an effective, stable, and a safer dosage form." Preformulation study is there for the multidisciplinary approach and utilizes involvement of several aspects of pharmacology, toxicology, clinical pharmacy, biochemistry, medicinal chemistry, and analytical chemistry (**Figure 1**). The preliminary objective of preformulation phase or study is to lay down foundation for transforming a new drug entity into a pharmaceutical formulation in such a way that it can be administered in a right way, in right amount, and on perhaps the most important at right target. The secondary objective preformulation study is to

**Figure 1.** *Outline of preformulation studies.*

provide longer stability to the formulation by proper designing and protecting drug component from environmental condition and to evaluate performance of developed formulation.
