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Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate
BACKGROUND: Hyperkalemia is a potentially life-threatening condition that patients with heart failure or chronic kidney disease, especially those taking renin–angiotensin–aldosterone system inhibitors, are at high risk of developing. Sodium polystyrene sulfonate (SPS), a current treatment, binds pot...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593397/ https://www.ncbi.nlm.nih.gov/pubmed/28919716 http://dx.doi.org/10.2147/DDDT.S143461 |
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author | Zann, Vanessa McDermott, John Jacobs, Jeffrey W Davidson, James P Lin, Fangling Korner, Paul Blanks, Robert C Rosenbaum, David P |
author_facet | Zann, Vanessa McDermott, John Jacobs, Jeffrey W Davidson, James P Lin, Fangling Korner, Paul Blanks, Robert C Rosenbaum, David P |
author_sort | Zann, Vanessa |
collection | PubMed |
description | BACKGROUND: Hyperkalemia is a potentially life-threatening condition that patients with heart failure or chronic kidney disease, especially those taking renin–angiotensin–aldosterone system inhibitors, are at high risk of developing. Sodium polystyrene sulfonate (SPS), a current treatment, binds potassium within the gastrointestinal tract to reduce potassium absorption. However, poor palatability limits its long-term use. RDX7675, a novel potassium binder in development for the treatment of hyperkalemia, is a calcium salt of a reengineered polystyrene sulfonate-based resin designed to have enhanced palatability. Here, the physical properties and palatability of RDX7675 and SPS are compared. METHODS: RDX7675 and SPS particle sizes were measured using wet dispersion laser diffraction. Palatability was assessed in a randomized, crossover, healthy volunteer study with two visits. At visit 1 (open label), volunteers evaluated high-viscosity, intermediate-viscosity, and water-reconstituted formulations of RDX7675 (all vanilla flavor), and an equivalent reconstituted SPS (Resonium A(®)). At visit 2 (single-blind), volunteers evaluated RDX7675 as a high-viscosity formulation in vanilla, citrus, and mint flavors, and as intermediate-viscosity, low-viscosity, and reconstituted formulations in citrus flavor. Volunteers used a “sip and spit” technique to rate overall acceptability and seven individual characteristics from 1 (“dislike everything”) to 9 (“like extremely”). RESULTS: RDX7675 particles were smaller than SPS particles, with a narrower size range (RDX7675, 80%, 14–52 µm; SPS, 11.3–124.2 µm), and had a smooth, spherical shape, in contrast to the shard-like SPS particles. Reconstituted RDX7675 was considered superior to SPS for five of the seven palatability characteristics and for overall acceptability (median, visit 1: reconstituted RDX7675, 5.0; SPS, 4.0). High-viscosity vanilla was the most highly rated RDX7675 formulation (median overall acceptability, visit 2: 7.0). CONCLUSION: The smaller, more uniformly shaped, spherical particles of RDX7675 resulted in improved palatability over SPS when reconstituted in water. The overall results are promising for future patient acceptability of RDX7675 treatment. |
format | Online Article Text |
id | pubmed-5593397 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-55933972017-09-15 Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate Zann, Vanessa McDermott, John Jacobs, Jeffrey W Davidson, James P Lin, Fangling Korner, Paul Blanks, Robert C Rosenbaum, David P Drug Des Devel Ther Original Research BACKGROUND: Hyperkalemia is a potentially life-threatening condition that patients with heart failure or chronic kidney disease, especially those taking renin–angiotensin–aldosterone system inhibitors, are at high risk of developing. Sodium polystyrene sulfonate (SPS), a current treatment, binds potassium within the gastrointestinal tract to reduce potassium absorption. However, poor palatability limits its long-term use. RDX7675, a novel potassium binder in development for the treatment of hyperkalemia, is a calcium salt of a reengineered polystyrene sulfonate-based resin designed to have enhanced palatability. Here, the physical properties and palatability of RDX7675 and SPS are compared. METHODS: RDX7675 and SPS particle sizes were measured using wet dispersion laser diffraction. Palatability was assessed in a randomized, crossover, healthy volunteer study with two visits. At visit 1 (open label), volunteers evaluated high-viscosity, intermediate-viscosity, and water-reconstituted formulations of RDX7675 (all vanilla flavor), and an equivalent reconstituted SPS (Resonium A(®)). At visit 2 (single-blind), volunteers evaluated RDX7675 as a high-viscosity formulation in vanilla, citrus, and mint flavors, and as intermediate-viscosity, low-viscosity, and reconstituted formulations in citrus flavor. Volunteers used a “sip and spit” technique to rate overall acceptability and seven individual characteristics from 1 (“dislike everything”) to 9 (“like extremely”). RESULTS: RDX7675 particles were smaller than SPS particles, with a narrower size range (RDX7675, 80%, 14–52 µm; SPS, 11.3–124.2 µm), and had a smooth, spherical shape, in contrast to the shard-like SPS particles. Reconstituted RDX7675 was considered superior to SPS for five of the seven palatability characteristics and for overall acceptability (median, visit 1: reconstituted RDX7675, 5.0; SPS, 4.0). High-viscosity vanilla was the most highly rated RDX7675 formulation (median overall acceptability, visit 2: 7.0). CONCLUSION: The smaller, more uniformly shaped, spherical particles of RDX7675 resulted in improved palatability over SPS when reconstituted in water. The overall results are promising for future patient acceptability of RDX7675 treatment. Dove Medical Press 2017-09-06 /pmc/articles/PMC5593397/ /pubmed/28919716 http://dx.doi.org/10.2147/DDDT.S143461 Text en © 2017 Zann et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Zann, Vanessa McDermott, John Jacobs, Jeffrey W Davidson, James P Lin, Fangling Korner, Paul Blanks, Robert C Rosenbaum, David P Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title | Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title_full | Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title_fullStr | Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title_full_unstemmed | Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title_short | Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate |
title_sort | palatability and physical properties of potassium-binding resin rdx7675: comparison with sodium polystyrene sulfonate |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593397/ https://www.ncbi.nlm.nih.gov/pubmed/28919716 http://dx.doi.org/10.2147/DDDT.S143461 |
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