Issue link: https://www.e-digitaleditions.com/i/1218534
10 March 2020 Tablets & Capsules U Ruchit Trivedi BioDuro Advancing poorly soluble drugs to the clinic: Rapid development of tablet formulations using milligrams of API formulation This article describes a streamlined approach to generating clinical formulations for poorly soluble compounds using milli- gram quantities of API. The article includes a case study in which formulators quickly determine the optimal formulation and manufacturing method for a particularly challenging drug candidate, enabling advancement to clinical trials. p to 70 percent of active pharmaceutical ingredi- ents (APIs) in today's drug pipeline are poorly soluble, which complicates delivery and results in poor bioavail- ability. Organic solvents, such as dimethyl sulfoxide (DMSO), are toxic and incompatible with clinical use; however, researchers often use them in early drug discov- ery and preclinical studies to assess their lead candidates. The challenge of poor solubility is often not properly addressed until late in the development process, which can create potential delays for clinical studies.