In vivostratum corneum distribution of lidocaine, assessed by tape stripping, from a new bioadhesive film

2010 ◽  
Vol 16 (1) ◽  
pp. 125-130 ◽  
Author(s):  
Cristina Padula ◽  
Andrea Fulgoni ◽  
Patrizia Santi
Keyword(s):  
1999 ◽  
Vol 5 (3) ◽  
pp. 208-212 ◽  
Author(s):  
F. Tokumura ◽  
K. Ohyama ◽  
H. Fujisawa ◽  
H. Nukatsuka

2007 ◽  
Vol 21 (8) ◽  
pp. 775-779 ◽  
Author(s):  
Z. Chik ◽  
A. Johnston ◽  
A. T. Tucker ◽  
R. T. Burn ◽  
D. Perrett

2000 ◽  
Vol 142 (3) ◽  
pp. 424-431 ◽  
Author(s):  
J. Mazereeuw-Hautier ◽  
D. Redoules ◽  
R. Tarroux ◽  
M. Charveron ◽  
J.P. Salles ◽  
...  

2021 ◽  
Author(s):  
Si Wen ◽  
Li Ye ◽  
Xiaohua Wang ◽  
Dan Liu ◽  
Bin Yang ◽  
...  

2010 ◽  
Vol 13 (1) ◽  
pp. 11 ◽  
Author(s):  
Wai Ling Au ◽  
Michael F Skinner ◽  
Isadore Kanfer

Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn. This was due to problems associated with the method and also inconsistencies and variability in the resulting data. The purpose of this study was to re-visit the tape stripping technique, incorporate refinements to reduce variability and validate the method using bioequivalence data obtained from the assessment of a topical corticosteroid cream containing 0.05% clobetasol propionate using the human skin-blanching assay. Methods: A pilot tape stripping study was conducted to establish the variability of the formulations.The bioequivalence of two different commercially available clobetasol propionate cream formulations and a clobetasol propionate ointment formulation were subsequently investigated using the tape stripping method. Results: The data from the pilot tape stripping study correlated well with data from the human skin-blanching assay. A subsequent pivotal tape stripping study confirmed bioequivalence between the two cream formulations whereas bio-inequivalence was demonstrated between the cream and ointment formulations.Conclusions: These studies show that the results from tape stripping concur with data from the human skin blanching assay and demonstrate the potential of a well-controlled tape stripping study as an option for the assessment of bioequivalence of topical corticosteroid formulations.


2013 ◽  
Vol 49 (3) ◽  
pp. 423-434 ◽  
Author(s):  
Anroop Nair ◽  
Shery Jacob ◽  
Bandar Al-Dhubiab ◽  
Mahesh Attimarad ◽  
Sree Harsha

Assessing the bioavailability of drug molecules at the site of action provides better insight into the efficiency of a dosage form. However, determining drug concentration in the skin layers following topical application of dermatological formulations is a great challenge. The protocols followed in oral formulations could not be applied for topical dosage forms. The regulatory agencies are considering several possible approaches such as tape stripping, microdialysis etc. On the other hand, the skin bioavailability assessment of xenobiotics is equally important for topical formulations in order to evaluate the toxicity. It is always possible that drug molecules applied on the skin surface may transport thorough the skin and reaches systemic circulation. Thus the real time measurement of molecules in the skin layer has become obligatory. In the last two decades, quite a few investigations have been carried out to assess the skin bioavailability and toxicity of topical/dermatological products. This review provides current understanding on the basics of dermatokinetics, drug depot formation, skin metabolism and clearance of drug molecules from the skin layers following application of topical formulations.


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