Lenz, Jan, Fuest, Frederik, Finek, Jan Hendrik, Bunjes, Heike, Kwade, Arno and Juhnke, Michael (2022) Tablet disintegration and dispersion under in vivo-like hydrodynamic conditions. Pharmaceutics, 14 (n.a.). pp. 1-25. ISSN 1999-4923

Abstract

Disintegration and dispersion are functional properties of the tablet relevant for the desired API release. The standard disintegration test (SDT) described in different pharmacopoeias provides only limited information about these complex processes and is considered for being not comparable with the biorelevant behaviour, e.g., due to the frequent appearance of high hydrodynamic forces. 3D tomographic laser-induced fluorescence imaging (3D Tomo-LIF) technique is applied to analyse tablet disintegration and dispersion by determination of disintegration time (DT) and time-resolved particle size distribution analysis in close proximity to the tablet in a continuously operated flow channel, adjustable to very low fluid velocities. A case study on tablets containing pharmaceutical polymers labelled with a fluorescence dye, a filler, disintegrants and different porosities is presented to demonstrate the functionality and precision of the novel method. DT results from 3D Tomo-LIF are compared with results from the SDT, confirming the analytical limitations of the pharmacopoeia disintegration test. Instead, the 3D Tomo-LIF method provides an in-depth understanding of the functional behaviour of the tablet material, composition and structural properties under in vivo-like hydrodynamic forces regarding disintegration and the temporal progress of dispersion. We are considering the 3D Tomo-LIF in vitro method as improved biorelevant and biopredictive in terms of hydrodynamic conditions in the human stomach.

Item Type:	Article
Date Deposited:	06 Feb 2022 00:45
Last Modified:	06 Feb 2022 00:45
URI:	https://oak.novartis.com/id/eprint/45585