Biopharmaceutics and Biologic Drugs

Solubility Enhancement

A variety of approaches can be used to improve the solubilization and bioavailability of a medication that is poorly water soluble. In screening tests of new chemical entities, as well as formulation design and development, solubilization of poorly soluble pharmaceuticals is a common difficulty. Any medicine that needs to be absorbed must be in the form of an aqueous solution at the absorption site. The maximum amount of solute that may be dissolved in a given amount of solvent is defined as'solubility.' It is defined quantitatively as the solute concentration in a saturated solution at a given temperature. Solubility is defined as the spontaneous interaction of two or more substances to generate a homogeneous molecular dispersion in qualitative terms. A saturated solution is one in which the solute and the solvent are in equilibrium. A drug's solubility can be expressed in a variety of ways, including parts, percentages, molarity, molality, volume fraction, and mole fraction. The science of establishing new methods, standards, and approaches to evaluate the safety, efficacy, quality, and performance of all FDA-regulated products is known as regulatory science.