Gel-forming Systems for Adhesion Prevention

用于预防粘附的凝胶形成系统

• 批准号: 6337837
• 负责人: SHALABY W SHALABY
• 金额: $ 10万
• 依托单位: POLY-MED, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2002-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6337837
• 关键词: abdomen; acetates; adhesions; calcium; cell adhesion; chemical synthesis; gel; hyaluronate; laboratory rat; nonblood rheology

DESCRIPTION (Verbatim from the Applicant's Abstract): Adhesion formation after abdominal surgery is a significant cause of post-operative morbidity. In gynecological surgery, adhesions can lead to infertility, chronic pain, and obstructive disorder. Numerous adhesion prevention adjuvant have been investigated, most of which are based on a pharmacological agents or protective barriers. However, no systematic studies have been conducted to determine the combined effect of a transient barrier and pharmacological agent using a local, controlled release system. This provided an incentive to conduct comparative studies on controlled release systems based on unique transient barriers containing previously tested pharmacological agents or potentially effective ones. Phase I objective is to determine the feasibility of using gel-forming, hyaluronic acid/calcium acetate aqueous solution and no aqueous absorbable liquid co polyester as transient barrier matrices to control release of pharmacologically active agents for preventing post-surgical adhesion. Phase I plans entail (1) identifying and synthesizing fast absorbing liquid gel-forming co-polyesters; (2) preparing and conducting comparative rheological studies on hyaluronic acid Ca acetate (HA/CaAc) and liquid copolyesters as candidate matrices for controlled drug release, (3) formulating, the selected (HA/CaAc) and liquid copolyesters with selected pharmacological agents; (4) validating, and conducting a pilot study on three rat models for evaluation of three types of post-surgical adhesion, (5) conducting' the main study and using the results to identify two promising formulations for a Phase II study This will entail (1) completing a comprehensive in vivo studies using three animal species; (2) selecting one final system and completing pertinent development and scale-up studies; and (3) initiating the safety study. PROPOSED COMMERCIAL APPLICATION: Successful completion of Phase I study will provide the bases for pursuing a Phase II study and eventual development and marketing of a unique, highly effective system for managing key post-surgical complications associated with several procedures. This will not only benefit patients, but also reduce the cost of healthcare.

描述(逐字摘自申请人摘要)：术后粘连形成 腹部手术是导致术后并发症的重要原因。在……里面 妇科手术、粘连可导致不孕、慢性疼痛和 阻塞性疾病。许多预防粘连的佐剂已经被 被调查的，其中大部分是基于一种药理学试剂或保护性药物 障碍。然而，还没有进行系统的研究来确定 暂时性屏障和药剂的联合作用使用局部， 控制释放系统。这提供了一种进行比较的动机 基于独特瞬变屏障的控释系统研究 含有先前测试过的药理药剂或可能有效 一个。第一阶段的目标是确定使用凝胶形成的可行性， 透明质酸/醋酸钙水溶液和无水可吸收 液态共聚酯作为暂态阻隔骨架控制药物释放 预防术后粘连的药理活性物质。第一阶段 计划包括(1)鉴定和合成快速吸收液体凝胶形成 共聚酯；(2)制备并进行比较流变学研究 透明质酸钙(HA/CAAc)和液体共聚酯作为候选材料 药物控释骨架，(3)配制，所选(HA/CAAC) 和液体共聚酯与选定的药理试剂；(4)验证， 并对三种类型的大鼠模型进行了初步研究 (5)开展主要研究，并利用研究结果 为了确定第二阶段研究的两种有希望的配方，这将需要 (1)使用三种动物物种完成全面的体内研究；(2) 选择一个最终系统并完成有针对性的开发和扩展 研究；(3)启动安全研究。 建议的商业应用： 成功完成第一阶段研究将为开展第二阶段研究奠定基础 并最终开发和营销一种独特的、高效的管理系统 与几种手术相关的关键手术后并发症。这不仅会 使患者受益，但也降低了医疗保健成本。