Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients

By Sanjay Konagurthu, Ph. D., Senior Director, Science and Innovation, and Tom Reynolds, Principal Scientist, Thermo Fisher Scientific

Low aqueous solubility is a major problem encountered during the formulation development of drug molecules. A drug that is not able to dissolve in a patient’s gastrointestinal tract is unable to be systemically absorbed and, as a result, carries a higher risk of failure during development.¹ Therefore, with about 70 to 90 percent of the drugs in development falling in the two low-solubility classes of the Biopharmaceutical Classification System (BCS),² it is critical that formulation scientists use the most appropriate solubility enhancement technology and formulation strategies to improve the bioavailability of poorly soluble drugs.