119. Development of a Tape-Stripping Method to Quantify Dermal Exposure to Hexamethylene Diisocyanate

2005 ◽  
Author(s):  
K. Fent ◽  
K. Jayaraj ◽  
A. Gold ◽  
L. Ball ◽  
L. Nylander-French
2011 ◽  
Vol 14 (3) ◽  
pp. 347 ◽  
Author(s):  
Natalie Rae Parfitt ◽  
Michael Frederick Skinner ◽  
Charles Bon ◽  
Isadore Kanfer

Purpose: Investigations were carried out to assess the use of tape stripping (TS) for the determination of bioequivalence of topical products containing 1% clotrimazole. Methods: The study design involved the establishment of an appropriate application time, which was determined by conducting a dose duration study. Subsequently, two bioequivalence studies were conducted: i) using the brand (Canesten Topical - 1% clotrimazole cream) as both the test and the reference product and ii) comparing Canesten cream with a gel product containing the same concentration of clotrimazole (1%). Each tape strip was individually analyzed for clotrimazole content using an HPLC method and Transepidermal Water Loss (TEWL) measurements were used to normalize the stratum corneum thicknesses between subjects. Results: The results of the TS investigations showed that, if the study is sufficiently powered, tape stripping may be used to determine bioequivalence according to the conventional bioequivalence limits of 0.8–1.25, as well as detect formulation differences between different clotrimazole products. Conclusions: The data from this study provided compelling evidence that tape stripping has the necessary attributes and potential to be used as a tool for the bioequivalence assessment of topical clotrimazole and/or other topical formulations, thereby circumventing the need to undertake expensive and time-consuming clinical trials for such products. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.


2004 ◽  
pp. 531-547 ◽  
Author(s):  
Hongbo Zhai ◽  
Howard Maibach ◽  
Myeong Jun Choi

1997 ◽  
Vol 32 (1) ◽  
pp. 33-42 ◽  
Author(s):  
Masayuki Matsumoto ◽  
Shoji Hayashi ◽  
Seiichi Arai

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shigeyuki Ono ◽  
Nobuhiko Eda ◽  
Takuya Mori ◽  
Atsuko Otsuka ◽  
Nobuhiro Nakamura ◽  
...  

Abstract Antimicrobial peptides (AMPs) play an important role in innate immunity in human skin. It is known that AMPs mainly function in the stratum corneum. Therefore, AMP concentrations in the stratum corneum need to be precisely measured to clarify functional and physiological importance of AMPs in cutaneous defence. Tape stripping (TS) is a well-established method by which components in the stratum corneum can be collected. However, the usefulness of the TS method for measuring AMP concentration in human skin remains unclear. Therefore, we compared it with another popular method, skin rinsing, which had been established as a method for measuring AMP concentration in human skin. When investigated on healthy medial forearm using RNase 7, which is one of the typical AMPs, as an index, there was a significant positive correlation between RNase 7 concentrations measured by the TS method at adjacent forearm sites, demonstrating the reproducibility of the TS method. Next, a significant positive correlation was detected in RNase 7 concentrations measured using the TS and the skin rinsing method, indicating that the TS method is comparable to the skin rinsing method. Thus, we speculate that the TS method is useful for measuring AMP concentration in human skin.


Author(s):  
Andrea Pensado ◽  
Anita McGrogan ◽  
K. A. Jane White ◽  
Annette L. Bunge ◽  
Richard H. Guy ◽  
...  

AbstractPredicting the dermal bioavailability of topically delivered drugs is challenging. In this work, minimally invasive stratum corneum (SC) sampling was used to quantify the delivery of betamethasone valerate (BMV) into the viable skin. Betnovate® cream (0.1% w/w BMV) was applied at three doses (2, 5, and 10 mg cm−2) to the ventral forearms of 12 healthy volunteers. The mass of drug in the SC was measured using a validated tape-stripping method (a) after a 4-h “uptake” period, and (b) following a 6-h “clearance” period subsequent to cream removal. Concomitantly, the skin blanching responses to the same doses were assessed with a chromameter over 22 h post-application. BMV uptake into the SC was significantly higher for the 5 mg cm−2 dose compared to those of 2 and 10 mg cm−2. In all cases, ~30% of the drug in the SC at the end of the uptake period was cleared in the subsequent 6 h. From the SC sampling data, the average drug flux into the viable epidermis and its first-order elimination rate constant from the SC were estimated as 4 ng cm−2 h−1 and 0.07 h−1, respectively. In contrast, skin blanching results were highly variable and insensitive to the dose of cream applied. The SC sampling method was able to detect a 50% difference between two applied doses with 80% power; detection of a 20% difference would require a larger sample size. SC sampling enabled quantitative metrics describing corticosteroid delivery to the viable epidermis to be determined. Graphical abstract


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