Formulation development for small molecules - liquid or lyophilized products
A molecule's solubility and permeability are two parameters that characterize the molecule with respect to the FDA's Bio-pharmaceutics Classification System; i.e. the BCS Class of the molecule.
Knowledge about the molecule's BCS category will inform formulation development efforts and correlate in vivo performance. Furthermore, formulation development can enhance the molecule's bioavailability by improving solubility (for Class 2 molecules) or permeability (for Class 3 molecules). Low solubility, low permeability, low dissolution rate, and susceptibility to first-pass metabolism in the liver comprise the primary set of reasons drugs fail on the path from discovery to market.