Early Phase Formulations: Stability and Bioavailability
The use of liquid formulations of drug candidates is popular in Phase I trials due to their being faster and cheaper to develop as well as a way of maximising oral bioavailability. Focus on reformulating to a more commercially suitable format such as solid dose usually occurs in later stage studies.
However, there is a growing consensus that if the two key attributes of stability and bioavailability are to be taken into full consideration, it is better to start considering the solid dose form during formulation development for first in human trials.
Why are stability and bioavailability so important in early stage formulation? What are the knock-on benefits of focusing on stability and bioavailability early on?