Orodispersible tablets (ODTs) offer rapid disintegration of the dosage form when placed on\nthe tongue, which leads to fast release of the active pharmaceutical ingredient. Despite increased use\nin diverse patient populations, there have been numerous challenges associated with ODTs. One\nsuch concern is the lack of standardised assessment of disintegration behaviour. In the European\nPharmacopoeia, â??orodispersiblesâ?? are defined as such if disintegration time is faster than 3 min.\nCommon in vitro measurement methods only provide single time point data and have limited\nphysiological accuracy. To determine more bio-predictive disintegration kinetics, a bench-top in vitro\noral cavity model (OCM) was modified and piloted to assess disintegration of three ODTs of differing\nhardness. All ODTs disintegrated similarly within the OCMâ??surface breakdown/swelling, initial\nâ??wash awayâ?? and final â??wash awayâ??. The distinct advantage presented within this pilot study using\nthe OCM is the opportunity to ascertain disintegration behaviour profiles of ODTs by evaluating\nchanges in the observable area during simulated oral processing. The model could be implemented\nas a decision-support tool during the early stages of the drug design process to improve acceptability\nand further understand ODT disintegration behaviour.
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