In vitro and sensory tests to design easy-to-swallow multi-particulate formulations

TL;DR

This study develops an in vitro model to evaluate swallowing dynamics of multi-particulate formulations, comparing results with sensory tests, and highlights the importance of particle size and vehicle viscosity in designing easier-to-swallow oral drug forms.

Contribution

It introduces an in vitro method for pre-screening multi-particulate oral formulations, correlating with sensory outcomes and optimizing particle size and viscosity parameters.

Findings

Smaller particles are easier to swallow.

Water thin liquids are less effective for clearance.

In vitro tests effectively predict swallowing ease.

Abstract

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.