Background: Solubility assessment of a new chemical entity during preformulation is found to be the most essential and crucial stride during the drug origination that involves various drug physicochemical properties. More deliberation has been made towards the drug aqueous solubility. Since water is the unique solvent of the biological system and it is well known that drugs should be reached to its receptor site in the body through the aqueous and non-aqueous solvent. Therefore, measuring and assessing the solubility of new chemical entities in various solvents is one of the foremost elements of compound characterization during the drug development process.
Objective: This review article tries to sum up the current experimental approaches and directed the recent advances in the experimental approaches to assess the quantitative estimation of solubility of a new drug entity during preformulation. A review includes the high throughput methods that are intended to determine the thermodynamic solubility of drug as well as also reporting some traditional methods that have been utilized for such studies. Advanced and modified methodology has been discovered by many researchers from the last five years and has been used to estimate the solubility of a new drug candidate.
Conclusion: Thus, this review aims to represent various Preformulatory approaches that forecast by various researchers from last five years (2015-2019) for the quantitative estimation of solubility of new drug candidate which can replace the reported traditional methods and targeting as well as representing some new modified approaches which are exclusively reducing the time and providing appropriate results for such studies.