ABSTRACT
SOLUBILITY AND PARENTERAL PRODUCTS This chapter provides a practical description of the physical phenomena leading to molecular level solubilization or dispersion of solutes (drugs) in a way that should enable the formulator to make informed decisions regarding formulation strategies for parenteral delivery. Solubility is discussed from the perspective of a thermodynamically defined equilibrium requiring several energetic steps in going from solute in a condensed phase to a solute in solution. Discussions will include the nonequilibrium state of supersaturation while focusing on the fit-for-purpose definition of solubility targeting parenteral drug delivery. The definition of solubility can relate to the solubility of any physical state of matter in another, or even in a similar state (miscibility), but this chapter will focus on solubility of a solid state in a liquid media, resulting in a solution mixture, which is of primary pharmaceutical importance for parenteral drug delivery (1).
