Palatability of a novel oral formulation of prednisone in healthy young adults
Year: 2017
Type: article
Study design: Clinical Trial
Abstract: OBJECTIVES: Prednisone is a widely used anti-inflammatory for a variety of conditions. While oral liquid formulations of prednisone enable weight-based dosing, children frequently find them to be objectionable due to bitter taste. This limitation of prednisone can adversely impact patient acceptance and may result in non-compliance. Efforts to mask flavours often result in poorly controlled, heterogeneous particle distributions and can provide ineffective taste masking. The present work utilized a novel drug delivery technology developed by Orbis Biosciences, Inc., to create an oral taste-masked formulation of prednisone. METHODS: The study examined the palatability of Orbis' microsphere prednisone formulation in healthy young adults (n = 24). Four test articles were used in the study including a reference formulation (Roxanne Laboratories), a control and the test formulation (Orbis) prepared in two different ways. Study participants were randomized in a crossover design. KEY FINDINGS: Results indicated that the test prednisone formulation was indistinguishable from the control, and both were preferable to the reference formulation in every category of palatability assessed using a validated 9-point Hedonic Scale. The data also suggested that preparing the microsphere suspension immediately before administration results in the most ideal palatability properties. CONCLUSIONS: In conclusion, the novel microsphere formulation technology was effective in taste-masking prednisone.
DOI: 10.1111/jphp.12710
Authors: Shasha Bai, Nathan Dormer, Catherine Shoults, Amanda Meyer, Carol D Pierce, Kathleen A Neville, Gregory L Kearns
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: green
Funders: University of Arkansas, National Institutes of Health, Translational Research Institute, University of Arkansas for Medical Sciences, National Center for Research Resources, National Center for Advancing Translational Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development
OpenAlex ID: W2591603955
