Novel Imaging Method to Quantify Stratum Corneum in Dermatopharmacokinetic Studies

Tape stripping the stratum corneum (SC) is used in topical bioequivalence studies. Formulations are compared using drug concentration profiles as a function of relative SC position; both of these parameters require quantification of SC amount removed per tape. Here, a novel imaging method to quantify SC on tape strips is described. Comparisons are made with established SC quantification methods, specifically weighing and UV pseudo-absorption. Six stratum corneum tape strips were measured 15 times by the three methods, which were compared for precision, signal:noise ratio, sample size and speed. Furthermore, 600 tape strips were assayed by each method, and correlations examined. Weighing exhibited low precision, extremely low signal:noise ratio, and was slow. UV pseudo-absorption had high precision, acceptable signal:noise ratio and was quick. However, only a fraction of the total SC removed is analysed, and inhomogeneity can affect the results. The new imaging method was precise, with high signal:noise ratio, and measured the whole SC sample, unaffected by inhomogeneity. In addition, the approach was rapid and has the potential for fast automated scanning of multiple tapes and for further image analysis. The novel imaging method has many advantages over established methods for quantifying SC amount per tape.