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Tablet Disintegration and Dispersion under In Vivo-like Hydrodynamic Conditions

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Disintegration and dispersion are crucial functional properties of tablets, playing a key role in achieving the desired release of the active pharmaceutical ingredient (API). The standard disintegration test (SDT), as outlined in various pharmacopoeias, offers limited insights into these intricate processes and is deemed incomparable to biorelevant conditions, primarily due to the frequent occurrence of high hydrodynamic forces. This study employs 3D tomographic laser-induced fluorescence imaging (3D Tomo-LIF) to analyze tablet disintegration and dispersion. The 3D Tomo-LIF method involves determining disintegration time (DT) and time-resolved particle size distribution in close proximity to the tablet within a continuously operated flow channel, adaptable to very low fluid velocities. A case study involving tablets of different porosity, composed of pharmaceutical polymers labeled with a fluorescent dye, a filler, and disintegrants, is presented to showcase the functionality and precision of this innovative method. DT results from 3D Tomo-LIF are compared with those from the SDT, highlighting the analytical limitations of the pharmacopoeial disintegration test. The findings from the 3D Tomo-LIF method reveal a significant impact of fluid velocity on disintegration and dispersion. Generally, tablets containing cross-linked sodium carboxymethyl cellulose (NaCMCXL) as a disintegrant exhibited shorter DTs compared to those containing polyvinyl polypyrrolidone (PVPP). Tablets containing Kollidon VA64 were observed to disintegrate through surface erosion. This novel method provides a comprehensive understanding of the functional behavior of tablet materials, composition, and structural properties under in vivo-like hydrodynamic forces, specifically concerning disintegration and the temporal progress of dispersion. The 3D Tomo-LIF in vitro method is considered to offer improved biorelevance in terms of hydrodynamic conditions in the human stomach.
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