Precise evaluation of topically applied corticosteroid potency. Modification of the Stoughton-McKenzie assay

Place, V. A.

doi:10.1001/archderm.101.5.531

Cited by 29 publications

(16 citation statements)

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“…Because of the relatively simple procedure, skin blanching tests may be used as a formulation screening or confirmation procedure in the development of topical steroid preparations. Other than vasoconstrictor activity determined by Stoughton-McKenzie skin blanching test [30,31], the therapeutic response of transepidermal water loss caused by retinoids has been investigated, but is currently not acceptable by the Agency.…”

Section: And Pharmacodynamic Studiesmentioning

confidence: 99%

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang

Raw

Lionberger

et al. 2012

AAPS J

233

164

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This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3). The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies.

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Section: And Pharmacodynamic Studiesmentioning

confidence: 99%

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang

Raw

Lionberger

et al. 2012

AAPS J

233

164

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“…Recent bioassay methods include the antimitotic effect on the stripped skin of the hairless mouse [14], the suppression of UV light-induced erythema [5], the psoriasis assay [8] and modifications of the McKenzie-Stoughton blanching test [6,10,17], Whichever bioassay is used, corticosteroid preparations are evaluated in a clinical trial with recent examples of lotions [12,16], creams [11. 13, 18] and gels [7], This paper will concentrate on our modification of the vasoconstric tor assay using human volunteers, which we believe we have improved and extended so that it may be used as a useful screening test for clinical efficacy besides being employed to determine the bioavailability of steroids from topical bases.…”

Section: Introductionmentioning

confidence: 99%

Bioavailability of Topical Steroids

Barry

1976

Dermatology

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This paper reviews our modification of the vasoconstrictor (blanching) assay for topical corticosteroids using human volunteers, which we have improved and extended so that it may be used as a useful screening test for clinical efficacy besides being employed to determine the bioavailability of steroids from topical bases. Work is reported on the blanching activities of (1) 14 novel steroids in ethanol, (2) hydrocortisone 17-butyrate in eight topical vehicles, (3) betamethasone 17-benzoate in foam, ointment, cream and gel bases, and (4) 61 commercial formulations used in Great Britain. Pharmacokinetic/pharmacodynamic relationships are discussed as aids to optimizing topical steroid treatment.

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“…In 12 healthy volunteers, a vasoconstriction assay was performed ac cording to standard methods [1,5] with alcoholic solutions of [3-methasone diproprionate in concentrations of 0.001% (2 x 10-6 m), 0.0001% (2 x 10-6 m) and 0.00001% (2 x 10-7 m). Into one part of these solutions, gentamicin was suspended in a twentyfold concentration of the steroid as in this relative concentration both drugs were applied clinically.…”

Section: Investigations O F Vasoconstrictor Activitymentioning

confidence: 99%

Corticosteroids versus Antibiotics

Raab¹,

Windisch²

1972

Dermatology

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The results of the in vitro and in vivo studies presented here demonstrate that gentamicin and β-methasone-17,21-diproprionate may safely be used together in combined preparations for topical therapy. In the presence of the glucocorticoid, the antibacterial activity of the antibiotic remains unimpaired; such is not the case with all the antibiotics investigated sofar on possible interactions with glucocorticoids. The measurement of topical glucocorticoid potency poses many problems. Among the various methods available, the vasoconstriction assay proved to be the most reliable and valuable device, as there exists an approximate correlation between the potency of glucocorticoids to provoke vasoconstriction and their relative clinical efficacy on skin lesions. In the vasoconstriction assay, the presence of gentamicin in a twentyfold concentration did not change the activity of β-methasone diproprionate. In this study, interactions between gentamicin and β-methasone diproprionate could be ruled out, from the angle of the antibiotic as well as from the angle of the glucocorticoid.

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Precise evaluation of topically applied corticosteroid potency. Modification of the Stoughton-McKenzie assay

Cited by 29 publications

References 0 publications

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Bioavailability of Topical Steroids

Corticosteroids versus Antibiotics

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