OPTIMIZED BIOELASTIC PATCHES TO PREVENT PRESSURE ULCERS

描述（由申请人提供）：本阶段SBIR研究工作旨在 证明缓冲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组织上的递送贴片， 预防压疮，同时更充分地利用独特的能力 用于将治疗药物持续释放到真皮。 先前的努力证明了持续治疗释放数周， 疗效显著，但25%至30%的贴片破损发生率 在最严重的情况下，内踝，狗的剪切应力点 Swaim的接合（行走）铸型模型。第一阶段的具体目标 建议是开发更坚固的膜，具有更好的装载和释放 第二阶段全面测试的准备能力： 制备并在体外测试三种生物弹性聚合物组合物， 用于改善韧性和接近零级释放曲线的膜，2）通过 评估单独的生物弹性贴片和当装载有生物弹性贴片时的功效。 血栓烷合成酶抑制剂（TSI），用于预防或减轻严重程度 压力导致的伤口本可行性研究采用四组 犬：第I组（n = 6，对照组），内侧未放置生物弹性补片 踝关节，II组（n = 6，无TSI的补片），III组（n = 6，补片 用1.0 mg/cm 2 TSI浸渍），和 第4组（n = 6，贴片浸渍1.0 mg/cm 2 TSI），使用第二种 选择聚合物 拟定商业应用：在美国，治疗压疮（褥疮）每年花费16亿美元。压疮一旦发生，极大地促进复发。 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长，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办法。 缓冲，坚韧的生物弹性膜独特的生物类药物输送能力可以提供预防的解决方案。

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.