It is commonly observed that many a times new chemical entities (NCE) suffer from sub-optimal properties as short half-life, lack of dose proportionality or a high variability when they transition to the clinical research phase. This often necessitates the reformulation of the product to ensure that it meets the desired drug delivery and efficacy needs.

The formulation optimization studies thus help in identification of formulation prototypes that can effectively address the above challenges, and in bridging the gap between the development teams and final commercial production.