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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Main Authors: Michael Zvidzayi, Seeprarani Rath, Charles Bon, Sagaran Abboo, Isadore Kanfer
Format: Article
Language:English
Published: MDPI AG 2021-09-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/13/9/1456
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author Michael Zvidzayi
Seeprarani Rath
Charles Bon
Sagaran Abboo
Isadore Kanfer
author_facet Michael Zvidzayi
Seeprarani Rath
Charles Bon
Sagaran Abboo
Isadore Kanfer
author_sort Michael Zvidzayi
collection DOAJ
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 <i>E<sub>max</sub></i> data following the fitting of the relevant response data to the <i>E<sub>max</sub></i> 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 doaj.art-b8c60ca30fbe46bfa4be23975a3a34e42023-11-22T14:48:01ZengMDPI AGPharmaceutics1999-49232021-09-01139145610.3390/pharmaceutics13091456A Novel Approach to Assess the Potency of Topical CorticosteroidsMichael Zvidzayi0Seeprarani Rath1Charles Bon2Sagaran Abboo3Isadore Kanfer4Biopharmaceutics Research Institute, Rhodes University, Grahamstown 6139, South AfricaBiopharmaceutics Research Institute, Rhodes University, Grahamstown 6139, South AfricaBiostudy Solutions LLC, Wilmington, NC 28401, USAFaculty of Pharmacy, Rhodes University, Grahamstown 6139, South AfricaBiopharmaceutics Research Institute, Rhodes University, Grahamstown 6139, South AfricaThe 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 <i>E<sub>max</sub></i> data following the fitting of the relevant response data to the <i>E<sub>max</sub></i> 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.https://www.mdpi.com/1999-4923/13/9/1456vasoconstrictor assayskin blanching responsechromametertopical corticosteroidsactive pharmaceutical ingredientspotency
spellingShingle Michael Zvidzayi
Seeprarani Rath
Charles Bon
Sagaran Abboo
Isadore Kanfer
A Novel Approach to Assess the Potency of Topical Corticosteroids
Pharmaceutics
vasoconstrictor assay
skin blanching response
chromameter
topical corticosteroids
active pharmaceutical ingredients
potency
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 vasoconstrictor assay
skin blanching response
chromameter
topical corticosteroids
active pharmaceutical ingredients
potency
url https://www.mdpi.com/1999-4923/13/9/1456
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