Preformulation Study

**3**

**Chapter 1**

Design

*Pinak Patel*

**Abstract**

Preformulation Studies: An

Integral Part of Formulation

in-depth knowledge about pharmaceutical formulation development.

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

**Keywords:** preformulation, physicochemical properties, prodrug,

stability studies, analytical profiling

**1. Introduction**

When a promising new chemical entity is synthesized, it needs transformation to appropriate formulation in order to show a better and desirable action at appropriate site. Preformulation study is a phase which is initiated once the new molecule is seeded. In a broader way, it deals with studies of physical, chemical, analytical, and pharmaceutical properties related to molecule and provides idea about suitable modification in molecule to show a better performance. Study of these parameters and suitable molecular modification can be linked to generation of effective, safer, stable, and reliable pharmaceutical formulation. Therefore, preformulation study is an approach for generation of pharmaceutical formulation which utilizes knowledge and area application of toxicology, biochemistry, medicinal chemistry, and analytical chemistry. The highlighted chapter is framed with a vision to provide an
