| In vitro-in vivo correlation study for the dermatopharmacokinetics of terbinafine hydrochloride topical cream. | |
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MedLine Citation:
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PMID: 23057672 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background: To investigate the relationship between dermatopharmacokinetic (DPK) tape stripping from in vitro and in vivo using 1% terbinafine hydrochloride topical cream as the model formulation. Methodology: In vitro and in vivo tape strippings were conducted on separated pig ear skin used as a biological membrane for franz diffusion cell testing and the non-hairy skin area at the ventral forearms of healthy volunteers, respectively. Terbinafine (1%) topical cream was applied to the skin for 0.5, 2, and 4 h. The drug profiles of terbinafine across the stratum corneum were determined immediately (time 0 h), and at 0.5, 1, 2, and 4 h after removing the formulation. The amounts of terbinafine were analyzed by a validated high-performance liquid chromatography-ultraviolet method. The area under the curve (AUC) and the maximum amounts of terbinafine absorption (Q(max)) were obtained from pharmacokinetic software. Partition coefficient (K(SC/veh)) and diffusion parameter (D/L(2)) were derived from the Fick's second law equation. During the schedule time of 8 h, the deviations of in vitro and in vivo data were 6.61 and 30.46% for AUC and Q(max), respectively. There was insignificant difference of the K(SC/veh) and the D/L(2) between excised pig ear and human skin. In addition, K(SC/veh) and D/L(2) at T(max) of 2 h were used to predict the AUC presented the value of 4.7481 %h whereas the true value calculated from pharmacokinetic software provided the value of 5.9311 %h differing from each other in approximate of 20%. Conclusions: In vitro tape stripping using the separated pig ear skin as a viable membrane of the franz diffusion cell testing demonstrates the potential to represent in vivo tape stripping in human for topical bioavailability/bioequivalence study of terbinafine hydrochloride 1% topical cream. |
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Authors:
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Suwadee Saeheng; Wichit Nosoongnoen; Supenya Varothai; Korbtham Sathirakul |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-10-12 |
Journal Detail:
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Title: Drug development and industrial pharmacy Volume: - ISSN: 1520-5762 ISO Abbreviation: Drug Dev Ind Pharm Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-10-12 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7802620 Medline TA: Drug Dev Ind Pharm Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Department of Pharmacy, Mahidol University , Bangkok , Thailand. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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