SBIR Phase I: Novel injectable long-acting local anesthetic for postoperative pain management

这一小企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力开发了新的止痛疗法，可以减少或消除手术后阿片类药物的使用。阿片类药物是术后疼痛控制的主要药物，大约80%的外科患者接受处方，但可能导致阿片类药物滥用障碍，10%的患者进展为长期使用。这种使用除了具有潜在的致命性外，还可能与不良事件有关，如成瘾、呼吸抑制、认知障碍、恶心、便秘；后果包括增加护理成本、住院时间和再住院率。这项拟议工作的目标是开发一种原型长效局部麻醉剂，这种麻醉剂易于使用，可以提供72小时的持续局部麻醉，并且存在有限的安全风险。这个SBIR第一阶段项目将对一种用于术后疼痛管理的新型长效局部麻醉剂进行配方优化。目前，长效局部麻醉的选择存在诸如持续时间短、费用高、疗效不佳、设备笨重和感染风险等缺点，这些限制了它们作为安全有效的术后疼痛管理的实用性。该项目将针对所需的药物释放情况优化配方参数。此外，所得配方的稳定性将得到验证，以确保足够的保质期稳定性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project develops novel pain therapeutics that can reduce or eliminate the use of opioids after surgery. Opioid-based medications are a mainstay of postoperative pain management, with approximately 80% of surgical patients receiving prescriptions, but may result in opioid-misuse disorders with 10% of patients progressing to long-term use. In addition to being potentially deadly, this use can be associated with adverse events, such as addiction, respiratory depression, cognitive impairment, nausea, constipation; consequences include increased cost of care, hospital length of stay, and readmission rates. The goal of the proposed work is to develop a prototype long-acting local anesthetic that is easy-to-use, can provide sustained local anesthesia for 72 hours, and presents limited safety risks. This SBIR Phase I project will perform formulation optimization of a novel long-acting local anesthetic for postoperative pain management. Currently, options for long-acting local anesthesia suffer drawbacks such as limited duration, high costs, inadequate efficacy, cumbersome equipment, and risk of infection; these limit their utility as safe and effective postoperative pain management. This project will optimize formulation parameters for the desired drug release profile. Additionally, the stability of the resulting formulations will be validated to ensure adequate shelf-life stability.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.