The increasing complexity of drug formulations is propelling the adoption of in vitro bioequivalence (IVBE) testing, which involves utilizing in vitro techniques to evaluate a test product’s bioavailability and bioequivalence to the reference drug product to accelerate drug development.

Several physicochemical properties are essential for comprehending a pharmaceutical formulation’s microstructure. These encompass parameters such as globule and particle size distribution, particle charge, polymorphic form, phase behavior, particle morphology, and molecular structure. The characterization, control, and optimization of these parameters are pivotal in achieving development success, as they facilitate a thorough understanding of how the formulation’s structure and properties influence the processing and performance of the drug product.