The structural diversity of ibuprofen sustained-release pellets on the same goal of bioequivalence consistency

The consistency evaluation, which is largely unexplored is crucial in regulating the quality and efficacy of generic drugs. In this report, after generic ibuprofen (IBU) sustained-release pellets were developed and validated as bioequivalent to the reference list drug (RLD) in 48 healthy human volunteers (p < 0.001***), three-dimensional (3D) structures of generic IBU pellets from bioequivalence tests, along with RLD were investigated and compared for architecture using Micro-computed tomography (Micro-CT). The surface and internal architectures of the pellets, sphericity, pellet volume, core volume and gray value have been evaluated in both static and dynamic conditions. The material distribution and composition of IBU pellets were characterized using synchrotron radiation-FTIR mapping. Although the structures of RLD and the generic products were not similar dynamically, identical release profiles and bioequivalence were obtained. Overall, micro-CT could be very useful for characterization of internal structure, material design and development of new dosage form.