Rapid Transdermal Delivery of Opioid Pain Medications

阿片类止痛药的快速透皮给药

• 批准号: 6550710
• 负责人: ALAN M SMITH
• 金额: $ 10.57万
• 依托单位: ALTEA THERAPEUTICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-15 至 2003-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6550710
• 关键词: analgesics; cancer pain; clinical research; drug delivery systems; drug design /synthesis /production; electroporation; human subject; laboratory mouse; morphine; opiate alkaloid; technology /technique development

DESCRIPTION (provided by applicant): The American Medical Association reports that undertreatment of pain is a major problem for cancer patients as well as for other disease conditions. Approximately 50-75% of cancer patients have pain that is undertreated, and 25% die in severe unrelieved pain. Noninvasive pain medication delivery systems are ideally suited to improve the quality of life for those who experience chronic pain. Currently available noninvasive systems are slow, variable, or require frequent dosing. The goal of this project is to demonstrate the capability of a novel thermal microporation method to enable rapid infusion of pain medication through the skin. The microporation method is a noninvasive, painless, needless, patch-based system which creates an array of microscopic openings in the stratum corneum that increases the drug flux significantly compared to drugs delivered through intact skin. Four top opioid candidates for microporation delivery will be evaluated with an in vitro drug delivery model system that involves studying freshly harvested hairless mouse skin to determine optimal formulation and microporation delivery parameters. The opioid candidates to be tested in vitro with the thermal microporation method include morphine, hydromorphone, fentanyl, and alfentanil. A small pilot clinical study will also be performed to determine the feasibility of delivering fentanyl with a commercially available transdermal patch in conjunction with the microporation system.

描述（由申请人提供）：美国医学会报告称，疼痛治疗不足是癌症患者以及其他疾病患者的一个主要问题。大约 50-75% 的癌症患者患有未得到充分治疗的疼痛，25% 的患者死于严重且无法缓解的疼痛。无创止痛药物输送系统非常适合改善慢性疼痛患者的生活质量。目前可用的非侵入性系统速度慢、变化多，或者需要频繁给药。 该项目的目标是展示一种新型热微孔化方法能够通过皮肤快速输注止痛药物的能力。微孔方法是一种无创、无痛、无针、基于贴片的系统，它在角质层中创建一系列微观开口，与通过完整皮肤输送的药物相比，显着增加了药物通量。四种用于微孔递送的顶级阿片类药物候选药物将通过体外药物递送模型系统进行评估，该系统涉及研究新鲜收获的无毛小鼠皮肤以确定最佳配方和微孔递送参数。通过热微孔法进行体外测试的阿片类候选药物包括吗啡、氢吗啡酮、芬太尼和阿芬太尼。还将进行一项小型试点临床研究，以确定使用市售透皮贴剂与微孔系统结合输送芬太尼的可行性。