Application of an Optimized Tape Stripping Method for the Bioequivalence Assessment of Topical Acyclovir Creams

2018 ◽  
Vol 19 (4) ◽  
pp. 1567-1573 ◽  
Author(s):  
Sumalatha Nallagundla ◽  
Srinivas Patnala ◽  
Isadore Kanfer
Keyword(s):  
Tape Stripping ◽  
Stripping Method ◽  
Bioequivalence Assessment ◽  
Topical Acyclovir

scholarly journals Bioequivalence of Topical Clotrimazole Formulations: An Improved Tape Stripping Method

2011 ◽  
Vol 14 (3) ◽  
pp. 347 ◽  
Author(s):  
Natalie Rae Parfitt ◽  
Michael Frederick Skinner ◽  
Charles Bon ◽  
Isadore Kanfer
Keyword(s):  
Reference Product ◽  
Transepidermal Water Loss ◽  
Hplc Method ◽  
Tape Stripping ◽  
Compelling Evidence ◽  
Application Time ◽  
Stripping Method ◽  
Bioequivalence Assessment ◽  
Tape Strip

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.

Tape Stripping Method and Stratum Corneum

2004 ◽  
pp. 531-547 ◽  
Author(s):  
Hongbo Zhai ◽  
Howard Maibach ◽  
Myeong Jun Choi
Keyword(s):  
Stratum Corneum ◽  
Tape Stripping ◽  
Stripping Method

scholarly journals Evaluation of the Stratum Corneum Exfoliated by Tape Stripping Method (No. 1)

1997 ◽  
Vol 32 (1) ◽  
pp. 33-42 ◽  
Author(s):  
Masayuki Matsumoto ◽  
Shoji Hayashi ◽  
Seiichi Arai
Keyword(s):  
Stratum Corneum ◽  
Tape Stripping ◽  
Stripping Method

scholarly journals Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products

2019 ◽  
Vol 36 (12) ◽  
Author(s):  
A. Pensado ◽  
W.S. Chiu ◽  
S. F. Cordery ◽  
E. Rantou ◽  
A. L. Bunge ◽  
...  
Keyword(s):  
Stratum Corneum ◽  
Statistical Power ◽  
Application Site ◽  
Tape Stripping ◽  
Local Skin ◽  
Drug Products ◽  
Single Time Point ◽  
Topical Acyclovir ◽  
Alternative Metrics

Abstract Purpose To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of alternative metrics of local skin bioavailability calculable from SC sampling experiments. Methods Three acyclovir creams were considered in two separate studies in which drug amounts in the SC after uptake and clearance periods were measured and used to assess bioequivalence. In each study, a “reference” formulation (evaluated twice) was compared to the “test” in 10 subjects. Each application site was replicated to achieve greater statistical power with fewer volunteers. Results SC sampling revealed similarities and differences between products consistent with results from other surrogate bioequivalence measures, including dermal open-flow microperfusion experiments. Further analysis of the tape-stripping data permitted acyclovir flux into the viable skin to be deduced and drug concentration in that ‘compartment’ to be estimated. Conclusions Acyclovir quantities determined in the SC, following a single-time point uptake and clearance protocol, can be judiciously used both to objectively compare product performance in vivo and to assess delivery of the active into skin tissue below the barrier, thereby permitting local concentrations at or near to the site of action to be determined.

scholarly journals Application of a dermatopharmacokinetic (DPK) method for bioequivalence assessment of topical metronidazole creams

2020 ◽  
Vol 23 ◽  
pp. 437-450
Author(s):  
Seeprarani Rath ◽  
Ashmita Ramanah ◽  
Charles Bon ◽  
Isadore Kanfer
Keyword(s):  
Statistical Power ◽  
Reference Product ◽  
Human Subjects ◽  
Tape Stripping ◽  
Gravimetric Analysis ◽  
Time Duration ◽  
Healthy Human ◽  
Topical Metronidazole ◽  
Negative Controls ◽  
Bioequivalence Assessment

Purpose: The main aim of the current research was to develop and apply a dermatopharmacokinetic (DPK) approach for the bioequivalence assessment of metronidazole (MTZ) topical cream products, indicated in the treatment of rosacea. Methods: A DPK methodology using tape stripping (TS) technique was developed by investigating the factors that may influence the TS results viz. tapes, dose durations, number of tapes to be used, pressure application, dose applied and gravimetric analysis of the tapes. An initial dose duration study was performed on 6 healthy participants to determine an appropriate application time duration using the Emax model. The SC thickness was normalised between participants using TEWL measurements. A pivotal study was conducted using both the arms of 10 healthy human participants to demonstrate the ability of the TS method for bioequivalence assessment by comparing the reference product to itself as a positive control and including products with higher and lower strengths of MTZ to serve as negative controls in order to confirm bioinequivalence. Results: Whereas the reference was found to be bioequivalent when compared to itself, the creams containing 0.56% and 0.95% MTZ (negative controls) were not bioequivalent (bioinequivalent). Furthermore, another product containing 0.75% MTZ was also assessed and was found to be bioequivalent to the reference product. In addition, the use of both forearms of each participant offered an important advantage of significantly reducing the number of human subjects required to demonstrate BE with a high statistical power of > 80%. Conclusion: The data obtained provides compelling evidence that the developed TS method has the potential to be a cost-effective surrogate alternative for lengthy and expensive clinical trials. Consequently, its application can facilitate faster development of generic products which would, in turn, lower the economic burden of healthcare.

scholarly journals Tape stripping method is useful for the quantification of antimicrobial peptides on the human skin surface including the stratum corneum

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shigeyuki Ono ◽  
Nobuhiko Eda ◽  
Takuya Mori ◽  
Atsuko Otsuka ◽  
Nobuhiro Nakamura ◽  
...  
Keyword(s):  
Antimicrobial Peptides ◽  
Stratum Corneum ◽  
Human Skin ◽  
Significant Positive Correlation ◽  
Skin Surface ◽  
Tape Stripping ◽  
Established Method ◽  
Positive Correlation ◽  
Physiological Importance ◽  
Stripping Method

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.

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