Use of an in vitro human skin permeation assay to assess bioequivalence of two topical cream formulations containing butenafine hydrochloride (1%, w/w) |
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| Affiliation: | 1. Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, PA 19486, USA;2. Bayer Consumer Care, Memphis, TN 38112, USA;3. Charles River Laboratories, Tranent, East Lothian, EH33 2NE, UK;1. Pharmaceutical Consultant, 11309 Dunleith Place, North Potomac, MD 20878, USA;2. Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila Bucharest, 6 Traian Vuia, 020956 Bucharest, Romania;3. Center for Drug Sciences, Faculty of Pharmacy, University of Medicine and Pharmacy Carol Davila Bucharest, 6 Traian Vuia, 020956 Bucharest, Romania;4. SAS Borvo, 18 avenue de Charade, 63122 Ceyrat, France;5. Department of Dermatology, School of Medicine, University of California, 2340 Sutter Street N461, 94115 San Francisco, CA, United States of America;1. UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, UK;2. GSK Consumer Healthcare UK Ltd., 980 Great West Road, Brentford, Middlesex TW8 9GS, UK;3. GSK Consumer Healthcare, 184 Liberty Corner Road, Suite 200, Warren, NJ, 07059, United States;1. UCL School of Pharmacy, 29-39 Brunswick Square, WC1N 1AX London, UK;2. University of Surrey, Guildford GU27XH, UK;3. Unilever Research Colworth, Colworth Park, Sharnbrook, Bedfordshire MK401LQ, UK;4. Pion Inc., 10 Cook Street, Billerica, MA 01821, United States;1. BASF SE, Experimental Toxicology and Ecology, Germany;2. BASF Personal Care and Nutrition GmbH, Germany;3. RWTH Aachen, Germany;4. BASF Schweiz AG, Switzerland;5. BASF SE, Paper Chemicals, Germany;1. Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, USA;2. Office of Process and Facilities, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, USA;3. Office of Generic Drugs, Office of Research and Standards, Center for Drug Evaluation and Research, FDA, USA |
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| Abstract: | The primary objective of this work was to investigate, using an in vitro human skin permeation study, whether changes in the excipients of butenafine hydrochloride cream would have any effect on bioperformance of the formulation. Such in vitro data would be a surrogate for any requirement of a bioequivalence (BE) study to demonstrate formulation similarity. A LC-MS/MS method for quantitation of butenafine in various matrices was developed and validated. A pilot study was performed to validate the in vitro skin permeation methodology using three cream formulations containing butenafine hydrochloride at concentrations of 0.5, 1.0 and 1.5% (w/w). Finally, a definitive in vitro human skin permeation study was conducted, comparing the extent of butenafine hydrochloride permeation from the new formulation to that from the current formulation. The results of the study comparing the two formulations showed that there was no statistically significant difference in the extent of butenafine permeation into human skin. In conclusion, these in vitro data demonstrated that the formulation change is likely to have no significant impact on the bioperformance of 1% (w/w) butenafine hydrochloride cream. |
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| Keywords: | Topical Skin permeation Bioequivalence Dermal Flux Butenafine |
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