NDLI: Assessing Topical Bioavailability and Bioequivalence: A Comparison of the In vitro Permeation Test and the Vasoconstrictor Assay

Content Provider	Springer Nature Link
Author	Lehman, Paul A. Franz, Thomas J.
Copyright Year	2014
Abstract	To compare the sensitivity of a pharmacokinetic assay, the in vitro permeation test (IVPT), with that of a pharmacodynamic assay, the human skin blanching or vasoconstrictor (VC) assay, in assessing the relative bioavailability of topical clobetasol propionate products.The percutaneous absorption of clobetasol propionate from five commercial products was measured in vitro using cryopreserved human skin. The pharmacodynamic potency of the same five products was also assessed in vivo using the VC assay, the surrogate method by which regulatory authorities in the United States establish the bioequivalence of generic topical glucocorticoid products.IVPT found total clobetasol absorption varying ten-fold from highest to lowest product, whereas the VC assay found this same difference was less than two-fold. The coefficient of variation ranged from 78 to 126% in the VC assay, but only 30–43% for IVPT. Statistically, IVPT could separate the 5 products into three groups: 1) ointment, 2) cream and gel, 3) emollient cream and solution). Due to its greater variability as well as saturation of the pharmacodynamic response at higher flux levels, the VC assay found all products except the solution to be equipotent.IVPT was found to be substantially more sensitive and less variable than the VC assay for assessing clobetasol bioavailability.
Starting Page	3529
Ending Page	3537
Page Count	9
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	31
Issue Number	12
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2014-07-09
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Clobetasol propionate Bioavailability Bioequivalence In vitro permeation test Vasoconstrictor assay Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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