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.

与局部注射相比，使用局部应用麻醉剂具有许多优点，例如消除患者与针头注射相关的疼痛和恐惧，避免引入感染的风险，降低无意针刺的职业风险，以及限制首过代谢。迄今为止，最广泛使用的表面麻醉方法是EMLA（局部麻醉剂的低共熔混合物）乳膏。然而，使用EMLA需要在繁重的封闭敷料下应用，并且在有效之前需要长时间接触。本研究的目的是调整和优化一种独特的专利皮肤涂层药物递送系统，以建立通过局部给药的局部麻醉剂的有效递送。为了证明该方法的可行性，具体目的是优化涂层以输送局部麻醉剂，确定涂层释放的局部麻醉剂的体外经皮吸收，证明动物模型中涂层的安全性，并在初步人体临床试验中评价涂层的有效性。拟议的商业应用：需要局部麻醉的手术数量和局部麻醉剂的使用范围正在稳步增加。将联合收割机成本有效的治疗与改进的便利性特征相结合的局部麻醉剂药物递送载体存在显著的商业潜力。