The effects of elevated and ambient temperature conditions on dilutions of fluocinolone acetonide ointment assessed using the human skin-blanching assay

Haigh, J.M. and Smith, E.W. (1995) The effects of elevated and ambient temperature conditions on dilutions of fluocinolone acetonide ointment assessed using the human skin-blanching assay. In: 1st World meeting on pharmaceutics, biopharmaceutics and pharmaceutical technology, Budapest, 9 to 11 May 1995 :. Association de pharmacie galénique industrielle (France)., Châtenay-Malabry, France, pp. 740-741.

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Abstract

Topical corticosteroid formulations have been in use now for some 30 years and many methods are available for the in vivo assessment of these preparations. Of all the assays described in the literature, the one first advocated by McKenzie and Stoughton, the so-called vasoconstrictor assay, is one of the most reliable if performed by experienced researchers using - the optimised methodology. Topical application of corticosteroids produces a whitening (blanching) of the skin, the intensity of which is directly proportional to the clinical efficacy of the formulation. Assessment of the degree of blanching produced is therefore of use in determining the rate and extent of corticosteroid release' from the semi-solid base through the stratum corneum. Since it is the degree of blanching which is measured, we prefer to call this test the human skin blanching assay. Some of the main advantages of this assay technique are that normal healthy skin is used therefore persons with dermatological complaints are not compromised, it is not painful for the volunteers, it is non-invasive and several formulations can be evaluated simultaneously. Most commercially available topical corticosteroid preparations have been formulated in such a way as to provide optimum release of the active ingredient from the base through the stratum corneum. Despite this fact, many practitioners often prescribe dilutions of topical corticosteroid formulations, presumably in an effort to reduce the unwanted side effects. This could be problematic; dilution with an incompatible base could destroy the delivery environment thus considerably reducing the efficacy of the formulation. The method of dilution could also play a role in the suitability of the final preparation. The objective of this work was to determine the effects of two different dilutions of fluocinolone ointment at both ambient and elevated temperature on the blanching produced by the dilutions and, by inference, the relative clinical efficacies of these dilutions compared to the full strength product.

Item Type:Book Section
Uncontrolled Keywords:human skin; blanching assay; fluocinolone acetonide ointment; dilution
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:630
Deposited By: Prof John Haigh
Deposited On:31 May 2007
Last Modified:06 Jan 2012 16:18
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