Solubility is defined as the maximum quantity of a substance that can be completely dissolved in a given amount of solvent, and represents a fundamental concept in fields of research such as chemistry, physics, food science, pharmaceutical, and biological sciences. The solubility of a substance becomes especially important in the pharmaceutical field because it often represents a major factor that controls the bioavailability of a drug substance. Moreover, solubility and solubility-related properties can also provide important information regarding the structure of drug substances, and in their range of possible intermolecular interactions. For these reasons, a comprehensive knowledge of solubility phenomena permits pharmaceutical scientists to develop an optimal understanding of a drug substance, to determine the ultimate form of the drug substance, and to yield information essential to the development and processing of its dosage forms.

In this chapter, the solubility phenomenon will be developed using fundamental theories. The basic thermodynamics of solubility reveals the relation between solubility, and the nature of the solute and the solvent, which facilitates an estimation of solubility using a limited amount of information. Solubility-related issues, such as the solubility of polymorphs, hydrates, solvates, and amorphous materials, are included in this chapter. In addition, dissolution rate phenomena will also be discussed, as these relate to the kinetics ofsolubility. A discussion of empirical methods for the measurement of solubility is outside the scope of this chapter, but is reviewed elsewhere (Grant and Higuchi, 1990; Grant and Brittain, 1995).

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