Abstract

In early drug development, the selection of a formulation platform and decisions on formulation strategies have to be made within a short timeframe and often with minimal use of the active pharmaceutical ingredient (API). At this stage, there is limited information available about the physicochemical and biopharmaceutical properties of a new drug candidate. The current work evaluated the various physicochemical parameters required to improve dissolution profile prediction accuracy at the early stage of drug development and estimate the effect of formulation strategies on the dissolution profile of immediate release tablets of a poorly soluble drug using in silico tools.