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A Novel Approach to Assess the Potency of Topical Corticosteroids

The potencies of topical corticosteroid products have mainly been classified using clinical data but in some instances, the US Food and Drug Administration’s (FDA’s) vasoconstrictor assay (VCA) to assess the skin blanching response has also been used. However, the reported skin blanching response da...

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Autores principales: Zvidzayi, Michael, Rath, Seeprarani, Bon, Charles, Abboo, Sagaran, Kanfer, Isadore
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8466269/
https://www.ncbi.nlm.nih.gov/pubmed/34575532
http://dx.doi.org/10.3390/pharmaceutics13091456
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author Zvidzayi, Michael
Rath, Seeprarani
Bon, Charles
Abboo, Sagaran
Kanfer, Isadore
author_facet Zvidzayi, Michael
Rath, Seeprarani
Bon, Charles
Abboo, Sagaran
Kanfer, Isadore
author_sort Zvidzayi, Michael
collection PubMed
description The potencies of topical corticosteroid products have mainly been classified using clinical data but in some instances, the US Food and Drug Administration’s (FDA’s) vasoconstrictor assay (VCA) to assess the skin blanching response has also been used. However, the reported skin blanching response data were often based on a single visual reading and lack information on the dose (amount/quantity) or dose duration. Although several lists classifying potencies of various topical corticosteroid products have been published, the inherent potencies of topical corticosteroid raw materials used as active pharmaceutical ingredients (APIs) have not been investigated. The objective was to rank the inherent potencies of topical corticosteroid APIs and to standardize dosing such that the relevant compounds could be compared on a normalized molar basis. The potencies of clobetasol propionate, halcinonide, mometasone furoate, and fluocinolone acetonide were compared using the resulting E(max) data following the fitting of the relevant response data to the E(max) model where mometasone furoate > fluocinolone acetonide = clobetasol propionate > halcinonide. This ranking lists the respective inherent potencies of the APIs, which will facilitate the choice of a suitable candidate for incorporation into an appropriate topical corticosteroid product for a specific clinical indication.
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spelling pubmed-84662692021-09-27 A Novel Approach to Assess the Potency of Topical Corticosteroids Zvidzayi, Michael Rath, Seeprarani Bon, Charles Abboo, Sagaran Kanfer, Isadore Pharmaceutics Article The potencies of topical corticosteroid products have mainly been classified using clinical data but in some instances, the US Food and Drug Administration’s (FDA’s) vasoconstrictor assay (VCA) to assess the skin blanching response has also been used. However, the reported skin blanching response data were often based on a single visual reading and lack information on the dose (amount/quantity) or dose duration. Although several lists classifying potencies of various topical corticosteroid products have been published, the inherent potencies of topical corticosteroid raw materials used as active pharmaceutical ingredients (APIs) have not been investigated. The objective was to rank the inherent potencies of topical corticosteroid APIs and to standardize dosing such that the relevant compounds could be compared on a normalized molar basis. The potencies of clobetasol propionate, halcinonide, mometasone furoate, and fluocinolone acetonide were compared using the resulting E(max) data following the fitting of the relevant response data to the E(max) model where mometasone furoate > fluocinolone acetonide = clobetasol propionate > halcinonide. This ranking lists the respective inherent potencies of the APIs, which will facilitate the choice of a suitable candidate for incorporation into an appropriate topical corticosteroid product for a specific clinical indication. MDPI 2021-09-13 /pmc/articles/PMC8466269/ /pubmed/34575532 http://dx.doi.org/10.3390/pharmaceutics13091456 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Zvidzayi, Michael
Rath, Seeprarani
Bon, Charles
Abboo, Sagaran
Kanfer, Isadore
A Novel Approach to Assess the Potency of Topical Corticosteroids
title A Novel Approach to Assess the Potency of Topical Corticosteroids
title_full A Novel Approach to Assess the Potency of Topical Corticosteroids
title_fullStr A Novel Approach to Assess the Potency of Topical Corticosteroids
title_full_unstemmed A Novel Approach to Assess the Potency of Topical Corticosteroids
title_short A Novel Approach to Assess the Potency of Topical Corticosteroids
title_sort novel approach to assess the potency of topical corticosteroids
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8466269/
https://www.ncbi.nlm.nih.gov/pubmed/34575532
http://dx.doi.org/10.3390/pharmaceutics13091456
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