A review of in vitro release test for method development and validation of semisolid dosage forms

The in vitro release test (IVRT) is a widely used method that can be employed to evaluate the performance
attributes of a semisolid topical dosage form, which includes creams, gels and ointments. Additionally, IVRT
has been utilized in bioequivalency studies after post-approval modifications to a product, have been
indicated, as well as in the detection of formulation changes. The combined effects of multiple
physiochemical properties, such as particle or droplet size, viscosity, matter microstructure arrangement,
and dosage form aggregation state, can be reflected by the in vitro release test (IVRT). The purpose of
developing and validating this method was to ensure its robustness, accuracy, selectivity, reproducibility,
precision, and reliability. To effectively evaluate the similarity between topical products and to verify
that the applied method has the required discriminatory power to detect differences between products,
should such differences exist, the IVRT method was demonstrated using a novel approach. A state-of-theart method for developing and assessing topical formulations is an automated IVRT diffusion system.
Additionally, the possible advantages are examined.