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Effect of formulation variables on oral grittiness and preferences of multiparticulate formulations in adult volunteers

Lopez, Felipe L.; Bowles, Alexandra; Gul, Mine Orlu; Clapham, David; Ernest, Terry B.; Tuleu, Catherine

Authors

Felipe L. Lopez

Alex Bowles Alex.Bowles@uwe.ac.uk
Senior Lecturer in Applied Pharmacology

Mine Orlu Gul

David Clapham

Terry B. Ernest

Catherine Tuleu



Abstract

© 2016 The Authors Multiparticulate formulations are composed of multiple solid dosage units which can be administered directly to the mouth or sprinkled on food. Oral grittiness (i.e. rough mouthfeel) may arise from the presence of particles in the mouth, limiting palatability. In this work, multiparticulate formulations were prepared by dispersion of spherical granules into orange flavoured vehicles thickened with hypromellose (HPMC) at different viscosities in order to assess oral perception of grittiness by a panel of thirty adults through direct scaling on a 100mm visual analogue scale. The effect of formulation factors such as particle size (90, 127, 263μm), amount of particles per 10ml (0.25, 0.50, 1.00g) and viscosity of the vehicle (0.08, 0.43, 2.80Pas) were investigated. Grittiness was increasingly perceived with increasing amount and size of particles. Increasing viscosity of the administration media had a masking effect on the perception of particles. Less gritty samples were generally regarded as ‘more pleasant’ by the participants of the study. However, samples dispersed in thickened vehicles seemed to be less preferred despite being less gritty; which could be ascribed to an unpleasant mouthfeel of the vehicle. In the design of multiparticulate formulations acceptable for a targeted patient group all these formulation factors will need to be considered and optimised.

Citation

Lopez, F. L., Bowles, A., Gul, M. O., Clapham, D., Ernest, T. B., & Tuleu, C. (2016). Effect of formulation variables on oral grittiness and preferences of multiparticulate formulations in adult volunteers. European Journal of Pharmaceutical Sciences, 92, 156-162. https://doi.org/10.1016/j.ejps.2016.07.006

Journal Article Type Article
Acceptance Date Jul 7, 2016
Online Publication Date Jul 9, 2016
Publication Date Sep 20, 2016
Deposit Date Sep 8, 2019
Publicly Available Date Mar 28, 2024
Journal European Journal of Pharmaceutical Sciences
Print ISSN 0928-0987
Electronic ISSN 1879-0720
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 92
Pages 156-162
DOI https://doi.org/10.1016/j.ejps.2016.07.006
Public URL https://uwe-repository.worktribe.com/output/2875029
Publisher URL https://doi.org/10.1016/j.ejps.2016.07.006
Additional Information This article is maintained by: Elsevier; Article Title: Effect of formulation variables on oral grittiness and preferences of multiparticulate formulations in adult volunteers; Journal Title: European Journal of Pharmaceutical Sciences; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.ejps.2016.07.006; Content Type: article; Copyright: © 2016 The Author(s). Published by Elsevier B.V.

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