OPTIMIZED BIOELASTIC PATCHES TO PREVENT PRESSURE ULCERS

描述(由申请人提供)：这项第一阶段的SBIR研究工作是为了 论证缓冲但更坚韧的生物弹性透皮药物的可行性 用于放置在压力敏感的骨隆起上的递送贴片 预防压疮，同时更充分地获取独特的能力 用于将治疗药物持续释放到真皮的贴片。 先前的努力显示了持续数周的治疗释放和 显著的疗效，但对于25%到30%的贴片断裂发生率 在狗最严重的内踝切应力作用下 斯瓦伊姆的粘合(行走)铸模。这一阶段的具体目标是 建议开发更坚韧的膜，具有更好的加载和释放性能 在第二阶段期间准备全面测试的能力：1) 三种生物弹性聚合物AS的制备及体外测试 用于改善韧性和接近零级释放曲线的膜，2)通过 评估生物弹性贴片单独和加载时的效果 血栓素合成酶抑制剂(TSI)预防或减轻严重程度 压力造成的伤口。这项可行性研究利用了四组 狗：I组(n=6，对照组)，内侧不放置生物弹性贴片 踝关节，II组(n=6)，无TSI斑块；Ill组(n=6)，斑块 浸渍1.0 mg/cm2的TSI)使用两种选择的聚合物之一，以及 第4组(n=6)，贴片中加入1.0 mg/cm2的TSI。 选定的聚合物。 拟议的商业应用：在美国，压力(地塞比妥)溃疡的治疗费用为每年16亿美元。一旦发生压力溃疡，极大地促进了复发。目前成功预防的手段是劳动密集型的，因此进一步增加了卫生保健负担。随着老年人口的不断增加，目前的前景是成本不断上升。一种有效的、成本相对较低的预防手段是适当的解决方案。缓冲、坚韧的生物弹性膜具有独特的生物类药物输送能力，可以为预防提供解决方案。

Description (provided by applicant): This Phase I SBIR research effort is to demonstrate feasibility of cushioning yet tougher bioelastic transdermal drug delivery patches for placement over pressure susceptible bony prominences for prevention of pressure ulcers, while more fully accessing the unique capacity of the patches for sustained release of therapeutic drug to the dermis. Previous efforts demonstrated sustained therapeutic release for weeks and remarkable efficacy, but for a 25 to 30 percent incidence of patch breakage under the most severe, medial malleolus, point of shear stress in the dog coaptation (walking) cast model of Swaim. The specific aims of this Phase I proposal are to develop tougher membranes with even better loading and release capacities in preparation for full scale testing during the Phase II: 1) By preparing and testing in vitro three compositions of bioelastic polymers as membranes for improved toughness and near zero order release profiles, 2) By assessing efficacy of the bioelastic patches alone and when loaded with a thromboxane synthetase inhibitor (TSI) for preventing or reducing the severity of pressure induced wounds. This feasibility study utilizes four groups of dogs: Group I (n = 6, controls) with no bioelastic patch placed over the medial malleolus, Group II (n = 6, patches without TSI), Group Ill (n = 6, patches impregnated with 1.0 mg/cm2 of TSI) using one of the two chosen polymers, and Group 4 (n = 6, patches impregnated with 1.0 mg/cm2 of TSI) using the second selected polymer. PROPOSED COMMERCIAL APPLICATION: Treatment of pressure (decubital) ulcers cost $1.6 billion/year in the U.S. Pressure ulcers, once having occurred, greatly facilitate recurrence. Current means of successful prevention is labor intensive and therefore adds further to the health care burden. With a growing geriatric population the present outlook is for mounting costs. An effective, relatively low cost means of prevention is the appropriate solution. Cushioning, tough bioelastic membranes of unique biology-like drug delivery capacity can provide the solution to prevention.