Sustained Release Ibuprofen Pellet

Formulation Impact on Sustained Release Pellet Matrix and Drug Release


Drug formulation is one of the key factors for generic drug developers in reproducing and improving upon the efficacy of the brand-name reference listed drug (RLD). For this study, we applied correlative imaging to study the microstructures of sustained release pellets in RLD and generic ibuprofen drug products. Dual energy X-ray tomography was used to reveal primary structures (sugar core, coating, and void space) and FIB-SEM to study secondary structures (API particles and microporosity matrix).

Controlled sustained release ibuprofen pellet microporosity RLD brand name
FIB-SEM reveals a rich microporosity network within a sustained release pellet.

Cross section imaging using FIB-SEM and a proprietary sample preparation protocol revealed microstructural differences of four generic samples, which are linked to an explanation of the differences in their release performance and failure to meet a pharmacopeia performance guidelines. In particular, differences in the tightness of the microporosity matrix was correlated with the release performance of the sustained release pellets. This study demonstrated that FIB-SEM cross sectioning and 3D imaging as important methodologies to study micro and nano-scale structural features resulting from different drug formulations and manufacturing conditions.

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