Solubility, the phenomenon of dissolution of solute in solvent to give a homogenous system,
is one of the important parameters to achieve desired concentration of drug in systemic
circulation for desired (anticipated) pharmacological response. Low aqueous solubility is the
major problem encountered with formulation development of new chemical entities as well
as for the generic development. More than 40% NCEs (new chemical entities) developed in
pharmaceutical industry are practically insoluble in water. Solubility is a major challenge for …

“Compounds with insufficient solubility carry a higher risk of failure during discovery and
development since insufficient solubility may compromise other property assays, mask
additional undesirable properties, influence both pharmacokinetic and pharmacodynamic
properties of the compound, and finally may affect the develop ability of the compound.”