N'Dri-Stempfer Berthe, Navidi William C, Guy Richard H, Bunge Annette L
Chemical Engineering Department, Colorado School of Mines, 1500 Illinois Street, Golden, Colorado 80401, USA.
Pharm Res. 2008 Jul;25(7):1621-30. doi: 10.1007/s11095-008-9577-4. Epub 2008 May 1.
Stratum corneum tape stripping post-application of a drug product followed by analysis of the active agent in this tissue layer is an approach being seriously considered for the comparative assessment of topical bioavailability. Key issues revolve around how best to perform this experiment and interpret the data.
Using previously published results from a comparative study of three 0.025% tretinoin gel products, alternative data analysis approaches are presented that may render the technique more accessible to the evaluation of new and generic topical dosage forms.
For the tretinoin gel study, the conclusions for bioequivalence from measurements of drug levels at only one uptake and one clearance time were the same as those from the original study, which required measurements at eight different treatment times. Furthermore, comparisons of drug levels at one uptake and one clearance time discriminated differences in bioequivalence for clearance and uptake, which had previously been missed. Half-life estimates, derived from time course data of drug clearance, can be related to lag time for drug penetration through the SC.
This new data analysis demonstrates that comparative bioequivalence might be assessed more easily.
在应用药品后进行角质层胶带剥离，随后分析该组织层中的活性剂，这是一种正在被认真考虑用于局部生物利用度比较评估的方法。关键问题围绕如何以最佳方式进行该实验以及解释数据。
利用先前发表的三项0.025%维甲酸凝胶产品比较研究的结果，提出了替代数据分析方法，这些方法可能使该技术更易于用于评估新的和通用的局部剂型。
对于维甲酸凝胶研究，仅在一个摄取时间和一个清除时间测量药物水平得出的生物等效性结论与原始研究相同，原始研究需要在八个不同治疗时间进行测量。此外，在一个摄取时间和一个清除时间比较药物水平能够区分清除和摄取方面生物等效性的差异，而这些差异在之前被遗漏了。从药物清除的时间进程数据得出的半衰期估计值可能与药物穿透角质层的滞后时间相关。
这种新的数据分析表明，比较生物等效性可能更容易评估。
