NOVEL DELIVERY SYSTEM FOR TOPICAL ANESTHESIA

新型表面麻醉输送系统

• 批准号: 6210189
• 负责人: BAKUL M BHATT
• 金额: $ 10.7万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6210189
• 关键词: anesthesia; drug delivery systems; drug design /synthesis /production; drug screening /evaluation; human subject; laboratory rabbit; lidocaine; polyvinyls; surface coating; topical drug application

The use of topically applied anesthetics presents numerous advantages over local injection such as eliminating the patient's pain and fear associated with needle injection, avoiding the risk of introducing infection, reducing the occupational risk of unintentional needle sticks, and limiting first-pass metabolism. To date, the most widely used method of topical anesthesia is EMLA (eutectic mixture of local anesthetics) cream. However, the use of EMLA requires application under a burdensome occlusive dressing and extended periods of contact before becoming effective. The goal of this study is to adapt and optimize a unique, patented skin coating drug delivery system to establish effective delivery of local anesthetics via topical administration. In order to demonstrate the feasibility of this approach, the Specific Aims are to optimize the coating to deliver topical anesthetics, to determine the in vitro percutaneous absorption of local anesthetics released from coatings, to demonstrate the safety of coatings in an animal model, and to evaluate the coatings for efficacy in a pilot human clinical trial. PROPOSED COMMERCIAL APPLICATIONS: The number of procedures requiring local anesthesia and the extent to which local anesthetics are being used is steadily increasing. Significant commercial potential exists for a topical anesthetic drug delivery vehicle that would combine cost effective treatment with improved convenience characteristics.

局部应用麻醉药的使用比局部注射具有许多优势，例如消除患者的疼痛和与针注射有关的疼痛和恐惧，避免了引入感染的风险，降低了无意识的针头棒的职业风险，并限制了首次代谢。迄今为止，最广泛使用的局部麻醉方法是emla（局部麻醉药的共晶混合物）乳膏。但是，使用EMLA需要在繁重的闭塞敷料和长时间的接触范围内申请，然后才能有效。这项研究的目的是适应和优化独特的，专利的皮肤涂料药物输送系统，以通过局部给药有效地递送局部麻醉药。为了证明这种方法的可行性，具体的目的是优化涂层以提供局部麻醉药，以确定从涂料中释放出的局部麻醉剂的体外经皮吸收，以证明在动物模型中涂料的安全性，并评估一项试验人类临床试验的涂料的涂料。拟议的商业应用：需要局部麻醉的程序数量以及使用局部麻醉剂的程度正在稳步增加。局部麻醉药品输送工具具有巨大的商业潜力，该工具将结合成本效益的治疗和改善的便利特征。