Dissolution Testing

Pharmaceutical dissolution testing is a standardized in vitro method used to evaluate the rate and extent of drug release from a dosage form into a dissolution medium under controlled conditions. It serves as a critical quality control tool to ensure batch-to-batch consistency, support regulatory compliance, and monitor stability throughout a product’s shelf life. The test is grounded in the principle that drug dissolution in gastrointestinal fluids is a prerequisite for absorption, and under certain conditions, dissolution rate can predict in vivo performance through in vitro–in vivo correlation (IVIVC). In product development, dissolution testing guides formulation optimization, detects manufacturing variations, and verifies that the drug release profile meets the intended therapeutic design, whether for immediate, delayed, or controlled release products.