The solubility of an API plays a crucial role in drug
disposition because the main pathway for drug absorption is a
function of permeability and solubility. Poor aqueous solubility
is caused by two main factors: high hydrophobicity and highly
crystalline structures. The aqueous solubility of a compound
plays a role in its success or failure as a drug candidate.
Better solubility results in better absorption in the
gastrointestinal tract, reduced dosage-level requirements, and
better bioavailability. In the development phase, poor
solubility can lead to inadequate exposure in efficacy and
toxicity studies. Higher dosages required to compensate for poor
solubility can lead to side effects, food effects, and
intersubject variability. It may drive up overall costs for drug
development and production and lead to poor patient compliance
because of the higher doses required to achieve a therapeutic
effect (1). As pharmaceutical companies attempt to resolve these
issues, contract-service providers and excipient suppl