Division of Pharmaceutics, Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa.
J Pharm Pharm Sci. 2010;13(1):11-20. doi: 10.18433/j3c01r.
A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn.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.
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.
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.
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.
美国食品和药物管理局于 1998 年发布了一份关于胶带剥离评估局部制剂生物利用度/生物等效性的指南草案，但后来被撤回。这是由于该方法存在问题，以及由此产生的数据不一致和可变性。本研究的目的是重新审视胶带剥离技术，采用改进方法降低变异性，并使用通过评估含有 0.05%丙酸氯倍他索的局部皮质类固醇乳膏的人体皮肤发白试验获得的生物等效性数据对该方法进行验证。
进行了一项初步的胶带剥离研究，以确定制剂的变异性。随后，使用胶带剥离法研究了两种不同市售丙酸氯倍他索乳膏制剂和一种丙酸氯倍他索软膏制剂的生物等效性。
初步胶带剥离研究的数据与人体皮肤发白试验的数据相关性良好。随后的关键性胶带剥离研究证实了两种乳膏制剂之间的生物等效性，而乳膏和软膏制剂之间则表现出生物不等效性。
这些研究表明，胶带剥离的结果与人体皮肤发白试验的数据一致，并证明了经过良好控制的胶带剥离研究作为评估局部皮质类固醇制剂生物等效性的一种选择的潜力。
