A novel soft robotic pediatric in vitro swallowing device to gain insights into the swallowability of mini-tablets.

Soft robotics could help providing a better understanding of the mechanisms underpinning the swallowability of solid oral dosage forms (SODF), especially by vulnerable populations such as the elderly or children. In this study a novel soft robotic in vitro device is presented, the Pediatric Soft Robotic Tongue (PSRT), inspired by the literature data on the anatomy and physiology of a 2-year-old child. Multi-particulate oral formulations (i.e., mini-tablets (MT)) were considered, including different scenarios such as SODF carrier (i.e., soft-food, liquid), administration methods, SODF size and volume fraction. In vitro results showed that semi-solid foods like yoghurt and apple puree (shear viscosity above ∼ 150 mPa.s at γ̇ = 50 s, and its yield stress up to ∼ 5 Pa) may be considered more suitable than thin liquids (i.e., xanthan gum 0.25 %) for swallowing MT. However, the reduction of MT size did not bring any benefit in terms of swallowability in the range studied. Regarding the administration method, spreading MT on top of a teaspoon full of carrier should be preferred over mixing MT with the carrier or placing MT on the tongue first to favour their swallowability. Finally, and under the in vitro conditions studied using yoghurt as carrier, it would be possible to increase the volume fraction of SODF up to 0.20 without influencing swallowability according to the three parameters evaluated (% of MT swallowed, bolus velocity, and post-swallow residues). These results should help to design more focused sensory and/or clinical tests to improve product formulation and patient acceptability.