Generic Controlled Release Capsule
Microstructure Equivalence

Microstructures are a critical characteristic to generic drug bioequivalence, as designated in the FDA's Q3 component of product similarity. In this study, a brand name controlled release ibuprofen drug was found to have a steady release of the applied pharmaceutical ingredient (API), while the generic drug had an irregular release. We used a FIB-SEM imaging technique to slice open and visualize the cross section of the drug pellets. Images revealed uniform porous networks in the brand name drug and microfracture structures in the generic drug, in part accounting for their different performance. This analysis determined that the generic product was far from achieving microstructural equivalence.  Beyond imaging, our analysis can be applied to quantify parameters critical to Q3 microstructure bioequivalence: drug particle size distribution, spatial homogeneity, microporosity, and amorphous-crystalline phase distribution. 

DigiM has received an FDA contract to enhance in vitro studies and Q3 microstructure bioequivalence analysis with imaging. Read more here.

Request more information about our analysis and this project.

FIB-SEM Brand Name vs. Generic Comparison

API in Uniform Porous Network (Left), No Pores for Drug Release (Right)