Fauth C, Wiedersberg S, Neubert R H H, Dittgen M
Jenapharm GmbH & Co. KG, D07745 Jena, Germany.
Drug Dev Ind Pharm. 2002 Nov;28(10):1251-9. doi: 10.1081/ddc-120015358.
Standard tensile strength and peel adhesion tests were carried out to investigate interactions of pressure-sensitive adhesives (PSAs) with several backing foils used for transdermal patches. Seven branded transdermal patches (Alora, Cutanum, Estraderm MX 50, Estraderm TTS 50, Fem7 -50 micrograms, Menorest, Oesclim) were included in the investigation. Their skin adhesion measured in several clinical trials was compared with the results of the laboratory measurements according to PSTC-1 (Peel Adhesion for Single Coated Tapes 180 degrees Angle, Pressure Sensitive Tape Council, Illinois, 1996), such as Young's modulus at 3% elongation and peel adhesion to stainless steel. Data obtained for the PSA-coated backings (laminates) show increasing elasticity with increasing PSA thickness. Interactions of PSAs with backing foil became evident in significant changes in Young's modulus by low PSA thickness, as seen for the silicone adhesive. The Young's moduli of the laminates were found to be influenced not only by the elasticity of the backing foil but also by the chemical structure of the PSA. There was no correlation between the elasticity and peel adhesion of both the laminates and the branded patches. Likewise, for the branded patches the peel adhesion to stainless steel does not correlate with skin adhesion values obtained from clinical trials. The Young's modulus of the branded patches was between 4 N/mm2 (Oesclim) and 501 N/mm2 (Fem7). For the branded transdermal patches no correlation was found between Young's modulus and both the peel force on stainless steel and the skin adhesion reported in studies.
进行了标准拉伸强度和剥离粘附力测试,以研究压敏胶粘剂(PSA)与用于透皮贴剂的几种背衬箔之间的相互作用。该研究纳入了七种品牌的透皮贴剂(阿洛拉、库塔努姆、雌二醇透皮贴剂MX 50、雌二醇透皮贴剂TTS 50、Fem7 - 50微克、美诺雷斯、奥司利姆)。将它们在多项临床试验中测得的皮肤粘附力与根据PSTC - 1(单涂层胶带180度角的剥离粘附力,压敏胶带协会,伊利诺伊州,1996年)进行的实验室测量结果进行比较,例如3%伸长率时的杨氏模量和对不锈钢的剥离粘附力。涂有PSA的背衬(层压材料)的数据显示,随着PSA厚度的增加,弹性增强。低PSA厚度时,杨氏模量发生显著变化,这表明PSA与背衬箔之间存在相互作用,如硅酮胶粘剂的情况。发现层压材料的杨氏模量不仅受背衬箔弹性的影响,还受PSA化学结构的影响。层压材料和品牌贴剂的弹性与剥离粘附力之间均无相关性。同样,对于品牌贴剂,对不锈钢的剥离粘附力与临床试验中获得的皮肤粘附力值也不相关。品牌贴剂的杨氏模量在4 N/mm²(奥司利姆)至501 N/mm²(Fem7)之间。对于品牌透皮贴剂,未发现杨氏模量与不锈钢上的剥离力以及研究中报告的皮肤粘附力之间存在相关性。