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首页> 外文会议>International Congress of Andrology >Topical Testosterone Replacement Therapy Based on the Skin Penetration EnhancerSEPA~R
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Topical Testosterone Replacement Therapy Based on the Skin Penetration EnhancerSEPA~R

机译：基于皮肤渗透的局部睾酮替代疗法〜r

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摘要

The penetration enhancer SEPA (2-n-nonyl-l,3-dioxolane) was formulated in a 1% testosterone hydroalcoholic gel (Opterone~R) to provide more efficient drug delivery. In a randomized 3-way crossover study in 15 hypogonadal men, testosterone pharmacokinetics (PK) of three daily 1.25 or 2.5 g doses of the SEPA-enhanced gel were compared to three daily 5 g doses of a marketed testosterone gel applied to abdomen skin. Areas under the concentration Vs time curve (AUC) suggested bioequivalence between 2.5 g of Opterone gel and 5 g of the marketed gel. To extend drug delivery to cover 24 hours after application, Opterone was reformulated into a cream. In a second PK study, 32 hypogonadal men were randomly assigned to receive seven daily doses of 3 different amounts of the cream. Maximum serum total testosterone concentrations (C_(max)) across treatment groups ranged from 400-800 ng/dL, and terminal serum half lives (T1/2) were approximately 50 hours. This new Opterone cream is currently in human clinical trials.
机译：渗透增强剂SEPA（2-N-壬基-1,3-二氧戊烷）在1％睾酮水醇凝胶（Opterne〜R）中配制，以提供更有效的药物递送。在15名低可动学性男性的随机3路交叉研究中，将睾酮药代动力学（PK）为每日1.25或2.5g的SEPA增强凝胶的3种或2.5g剂量的3种每日5克施用到腹部皮肤的睾丸激素凝胶。浓度VS时间曲线（AUC）下的区域建议生物等效于2.5克肺渗凝胶和5克的营销凝胶。为了延长药物递送以在施用后24小时覆盖，将肺化物重新重整为乳膏。在第二次PK研究中，32名低因族男性随机分配32名每日剂量3种不同量的奶油。在治疗组上的最大血清总睾酮浓度（C_（MAX））范围为400-800ng / dL，末端血清半衰期（T1 / 2）约为50小时。这种新的Opterone霜目前处于人类临床试验中。

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