The importance and criticality of dissolution testing throughout the pharmaceutical drug development lifecycle is well-known and has been well-documented in literature. “Dissolution testing measures the extent and rate of solution formation from a dosage form, such as a tablet, capsule, or ointment,” says Sool Yeon Cho, department scientist, Nelson Laboratories. “The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.”
Dissolution rate specifications vary depending on the design of the dosage form. In 2018, FDA updated its guidance on recommendations for dissolution testing and specification criteria for immediate-release dosage forms that contain highly soluble compounds.