Flexible dosing and ease of swallowing are key factors when designing oral drug delivery systems for paediatric and geriatric populations. Multi-particulate oral dosage forms can offer significant benefits over conventional capsules and tablets. This study proposes the use of an in vitro model to quantitatively investigate the swallowing dynamics in presence of multi-particulates. In vitro results were compared against sensory tests that considered the attributes of ease of swallowing and post-swallow residues. Water and hydrocolloids were considered as suspending vehicles, while the suspended phase consisted of cellulose pellets of two different average sizes. Both in vivo and in vitro tests reported easier swallow for smaller multi-particulates. Besides, water thin liquids appeared not optimal for complete oral clearance of the solids. The sensory study did not highlight significant differences between the levels of thickness of the hydrocolloids. Conversely, more discriminant results were obtained from in vitro tests, suggesting that a minimum critical viscosity is necessary to enable a smooth swallow, but increasing too much the carrier concentration affects swallowing negatively. These results highlight the important interplay of particle size and suspending vehicle rheology and the meaningful contribution that in vitro methods can provide to pre-screening multi-particulate oral drug delivery systems before sensory evaluation.

Swallowing disorders deteriorate significantly the quality of life and can be lifethreatening. Texture modification using shear thinning food thickeners have proven effective in the management of dysphagia. Some studies have recently considered the positive role of cohesiveness, but there is still an insufficient understanding of the effect of the rheological properties of the liquid bolus on the dynamics of bolus transport, particularly when elasticity and extensional properties are combined with a shear thinning behaviour. This study combines steady shear, SAOS and capillary breakage extensional rheometry with an in vitro method to characterize the oral transport of elastic liquids. Bolus velocity and bolus length were measured from in vitro experiments using image analysis and related to the shear and extensional properties. A theory describing the bolus dynamics shows that the elastic and extensional properties do not influence significantly the oral transit dynamics. Conversely, in vitro results suggest that the extensional properties can affect the transition from the oral to the pharyngeal phase of swallowing, where thin, viscoelastic liquids lead to a fast transit, lower oral post-swallow residues and more compact bolus with a smoother surface, which may suggest a lower risk of fragmentation. This mechanistic explanation suggests that the benefit of the extensional properties of thin viscoelastic liquids in the management of dysphagia should be further evaluated in clinical trials.

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Abstract. Pumping suspensions and pastes has always been a significant technological challenge in a number of industrial applications ranging from food processing to mining. Peristaltic pumps have become popular to pump and/or dose complex fluids, due to their robustness. During the transport of suspensions with peristaltic pumps, clogging issues may arise, particularly during transient operations. That is a matter of particular concern whenever the pumping device is used intermittently to generate flow only on demand. Further understanding of the transient dynamics of such systems and of the conditions that can lead to jamming would result in more robust peristaltic pump design. To achieve these goals, an experimental setup that simplifies the statorrotor assembly of a peristaltic hose pump was used. In this setup, a roller transfers momentum to a liquid suspension, upon application of a constant load. The evolution of the velocity of the roller was recorded for different concentrations of mono-dispersed spheres of different diameters. The flow is found not to be strongly dependent on the dispersed particle volume fraction, if the size of the suspended phase is comparable with the hose diameter. Conversely, the flow is strongly slowed down when their size is small and the particle concentration is increased. These findings could help improving the design of peristaltic pumps by a more appropriate sizing, given the diameter of the hose and that of the particles to be transported.

Abstract. Swallowing disorders are not uncommon among elderly and people affected by neurological diseases. For these patients the ingestion of solid grains, such as pharmaceutical oral solid formulations, could result in choking. This generally results in a low compliance in taking solid medications. The effect of the solid medication size on the real or perceived ease of swallowing is still to be understood from the mechanistic viewpoint. The interplay of the inclusion shape and the rheology of the liquid being swallowed together with the medication is also not fully understood. In this study, a model experiment was developed to study the oropharyngeal phase of swallowing, replicating the dynamics of the bolus flow induced by the tongue (by means of a roller driven by an applied force). Experiments were performed using a wide set of solid inclusions, dispersed in a thick Newtonian liquid. Predictions for a simple theory are compared with experiments. Results show that an increase in the grain size results in a slower dynamics of the swallowing. Furthermore, the experiments demonstrated the paramount role of shape, as flatter and more streamlined inclusions flow faster than spherical. This approach can support the design of new oral solid formulations that can be ingested more easily and effectively also by people with mild swallowing disorders.

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