Dissolution testing is a critical enabler for formulation process development as well as determination of product quality at release and on stability for solid oral dosage forms. In the pharmaceutical industry worldwide, this type of test is performed in the range of millions annually. We developed an improved chromatographic protocol combining the utilization of smaller internal diameter (i.d.) columns, superficially porous column technology, injection cycle time for gradient re-equilibration, system dwell volume understanding, and basic separation concepts for optimization as a greener, faster, yet robust way to conduct dissolution testing. Comparing this approach to standard analysis using a conventional approach, this methodology provides 70−80% reduction in solvent consumption and waste generation, as well as run times with equivalent accuracy, precision, and robustness. Feasibility of this approach was demonstrated by applying it to multiple drug products and those head-to-head comparisons showed that dissolution profiles and overall variability are comparable to those obtained by the conventional chromatographic approaches.

No abstract