How Does Media Selection Impact Performance Testing Of Poorly Soluble Drugs?

The flexibility and convenience of oral drug delivery has made it the most commonly used dosage form in the pharmaceutical industry. However, the solubility of a drug in the gastrointestinal (GI) tract ― and, ultimately, its efficacy ― is highly dependent on its physicochemical properties and the patient’s GI fluid properties. Drug candidates identified as poorly soluble (i.e., Class II and IV in the biopharmaceutics classification system) require proper formulation with the most appropriate excipients to increase solubility, which is an issue for 70% to 80% of small molecules at the discovery stage.¹ In vitro testing can help predict bioperformance but only if the right biorelevant dissolution media (BDM) is used by a company’s formulation experts.