Roy S D, Flynn G L
College of Pharmacy, University of Michigan, Ann Arbor 48109-1065.
Pharm Res. 1990 Aug;7(8):842-7. doi: 10.1023/a:1015912932416.
The permeation of fentanyl and sufentanil through cadaver skin membranes was investigated using in vitro diffusion cell techniques. Neither drug influenced the permeation of the other when they were concurrently applied to the skin membrane. With respect to transdermal delivery, short diffusion lag times of less than 0.5 hr were observed for each compound. Their permeation rates through heat-isolated epidermis and dermatomed (200- to 250-microns) skin sections were essentially the same. However, when the stratum corneum was removed by tape stripping, the respective permeability coefficients were increased greater than 30-fold, establishing the stratum corneum as the principal barrier to their skin permeation. Permeation was also studied as a function of pH. From pH 4 to pH 8 the permeability coefficients of both fentanyl and sufentanil, calculated from the total solution concentration regardless of ionization, increased exponentially. The free base is thus responsible for the relatively facile skin permeation of these drugs. Factoring of the independent permeability coefficients of the ionized and free-base forms was possible, with the latter being over two log orders larger than seen for the protonated species. Permeability coefficients of fentanyl and sufentanil through skin sections obtained from different cadavers varied four- to fivefold. Neither gender nor age was a flux-determining variable for either drug. The permeability coefficients of the drugs through skin sites as diverse as the sole of the foot, chest, thigh, and abdomen were remarkably similar. Their fluxes were sufficient for transdermal administration.
采用体外扩散池技术研究了芬太尼和舒芬太尼透过尸体皮肤膜的情况。当这两种药物同时应用于皮肤膜时,彼此均不影响对方的渗透。关于透皮给药,每种化合物的扩散滞后时间均小于0.5小时。它们透过热隔离表皮和厚度为200至250微米的皮肤切片的渗透速率基本相同。然而,当用胶带剥离去除角质层后,各自的渗透系数增加了30倍以上,表明角质层是它们皮肤渗透的主要屏障。还研究了渗透与pH的关系。从pH 4到pH 8,无论电离情况如何,根据总溶液浓度计算的芬太尼和舒芬太尼的渗透系数均呈指数增加。因此,游离碱是这些药物皮肤渗透相对容易的原因。可以分别计算离子化形式和游离碱形式的独立渗透系数,后者比质子化形式的渗透系数大两个对数级以上。从不同尸体获取的皮肤切片中,芬太尼和舒芬太尼的渗透系数相差4至5倍。性别和年龄均不是这两种药物通量的决定变量。这两种药物透过诸如脚底、胸部、大腿和腹部等不同皮肤部位的渗透系数非常相似。它们的通量足以用于透皮给药。