A New Method for Treating Sleep Disorders

治疗睡眠障碍的新方法

• 批准号: 6442625
• 负责人: LARRY D NICHOLS
• 金额: $ 25.46万
• 依托单位: BIOTEK, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-19 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6442625
• 关键词: circadian rhythms; clinical research; dosage; hormone regulation /control mechanism; human subject; melatonin; skin absorption; skin irritation /irritant; sleep disorders; technology /technique development; transdermal drug delivery; wakefulness

DESCRIPTION (provided by applicant): BIOTEK has developed a transdermal melatonin formulation capable of producing flux levels high enough to allow a small patch to deliver a night-time melatonin pulse similar to that of healthy young adults. Such delivery should foster drowsiness, restful sleep, and alert waking more effectively than available oral dose forms and would also be more easily administered to impaired or uncooperative subjects. Because transdermal melatonin provides non-invasive delivery of a human hormone at natural levels, it should not lead to tolerance or harmful side effects. Transdermal melatonin may be of value to night shift workers, elderly individuals who lack an endogenous high-amplitude melatonin cycle, long distance air travelers, and those with sleep or seasonal affect disorders. In Phase I GMP patches were made and characterized, stability studies were initiated, a human Clinical Protocol was developed with the Brigham and Women?s Sleep Center in Boston, MA, and a draft IND was prepared. Phase II will conduct a human clinical study aimed at establishing safety and testing efficacy under well-controlled conditions. PROPOSED COMMERCIAL APPLICATION: A melatonin patch should encourage development of transdermal systems for other cyclic hormones, leading to products capable of modifying or restoring other types of hormone-mediated behavior.

描述（由申请人提供）：BIOTEK开发了一种透皮 褪黑激素制剂能够产生足够高的通量水平， 小贴片，以提供与健康人类似的夜间褪黑激素脉冲 年轻人这样的分娩应该促进困倦，宁静的睡眠， 比现有的口服剂型更有效地唤醒， 容易给受损或不合作的受试者使用。因为透皮 褪黑激素以自然水平提供人类激素的非侵入性递送， 它不应导致耐受性或有害的副作用。褪黑激素透皮贴剂 可能对夜班工人、缺乏睡眠的老年人有价值。 内源性高幅度褪黑激素循环，长途航空旅行者， 有睡眠或季节性情绪障碍的人。在第一阶段，制作了GMP贴片 并进行了表征，启动了稳定性研究， 是和布里格姆妇女协会一起开发的吗在马萨诸塞州波士顿的睡眠中心， 起草了IND。第二阶段将进行人体临床研究， 在良好控制的条件下确定安全性和测试有效性。 拟定商业应用：褪黑激素贴片应该鼓励开发其他周期性激素的透皮系统，从而开发出能够改变或恢复其他类型的激素介导行为的产品。