A Review on Hydrotropic Solubilization for Poorly Water Soluble Drugs: Analytical Application and Formulation Development

Abstract

Solubilisation of poorly soluble drugs is encountered as a challenge in screening studies of new chemical entities as well as its formulation development is obstacle. A number of methodologies can be adapted to improve solubility of poor water soluble drug and its bioavailability. Hydrotropes possess the ability to increase the solubility of sparingly soluble and poorly soluble drugs in water. It is a molecular phenomenon, adding a second solute (i.e. hydrotrope) helps to increase the aqueous solubility of poorly soluble drug. The presence of a excess quantity of one solute enhances the solubility of another solute. Various organic solvents are used for the development of analytical methods for poorly water soluble drugs. The major drawback of such solvents is cost, toxicity and environmental hazards. To overcome these issues less costly hydrotropic agents have gain wide application for the development of analytical methods for routine analysis of marketed dosage form and developed dosage forms. The mixed hydrotropy approach suggests the minimum amount of the hydrotropic agents as a blend of two or more agents. Such blends results in lesser quantity as that of single hydrotropic agents. Similarly the hydrotropic agents are now days widely used to develop dosage forms as solid dispersion, mouth dissolving tablets, injections to improve therapeutic effectiveness and bioavailability for poorly water soluble drugs.