Sprayable Hydrogel Barrier for the Delivery of Adhesion-Preventing Therapeutics

摘要 腹腔内手术后粘连形成会造成重大的健康风险，被认为是导致小血管并发症的主要原因。 肠梗阻和女性不孕症预防这些粘连的方法目前仅限于屏障 薄膜，其难以放置并且经常被限制用于防止粘连到手术切口部位， 使得大部分腹腔内容物没有受到保护这些屏障产品也不能解决组织 引起大多数粘连的反应。该计划将重点放在优化一种低成本，可喷涂的屏障 它会在腹腔内流动并粘附在腹腔的内部组织上， 所有内表面的粘连。这种水凝胶也将提供抗炎或纤维蛋白溶解治疗 以减轻导致粘连形成的局部生物反应。Luna Labs将优化产品 在啮齿动物中完成初步有效性验证之前，使用体外表征的制剂 腹腔粘连形成模型。这些结果将支持第二阶段向产品 商业化并提交给FDA。

ABSTRACT Adhesion formation after intra-abdominal surgery poses a significant health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films, which are difficult to place and are often restricted to use preventing adhesions to the surgical incision site, leaving the bulk of the abdominal contents unprotected. These barrier products also fail to address the tissue response that causes most adhesions. This program will focus on the optimization of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing protection from adhesions for all internal surfaces. This hydrogel will also deliver anti-inflammatory or fibrinolytic therapeutics to mitigate local biological responses responsible for adhesion formation. Luna Labs will optimize the product formulation using in vitro characterization before completing preliminary validation of efficacy in a rodent abdominal model of adhesion formation. These results will support a Phase II transition effort towards product commercialization and submission to the FDA.