SBIR Phase II: Biodegradable Polymer Film for Sustained Delivery of Antibiotics to the Surface of the Eye

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力将是通过直接向眼睛输送抗生素，更有效地治疗严重的感染性角膜溃疡。通过一种新型的、可生物降解的柔性聚合物薄膜。该平台将持续给药，从而消除了每小时滴眼液的需要。本产品可在受伤时立即使用，使卫生专业人员能够确保最佳治疗和结果。该平台解决了角膜感染的即时医疗需求，这是由于隐形眼镜佩戴不当造成的，以及美国军队中眼睛创伤发生率的增加。在世界范围内，由于难以获得和使用药物，角膜溃疡通常会导致失明。这些含抗生素的薄膜？高分子科学、化学生物工程和药物配方创新的结合？通过采用这种新颖的平台，将为远远超出角膜溃疡的视力威胁条件带来改进的商业可用解决方案，该平台提供了有效，易于管理，广泛应用的持续，局部眼科药物输送。更广泛的社会影响在于科学和技术的发现和创新，以及教育/培训他人在聚合物给药科学方面的进步的能力。拟议的产品基于专有的交联透明质酸（HA）聚合物技术，与抗生素一起配制，可在数天内局部连续地将药物输送到眼表。透明质酸具有良好的愈合效果，与持续释放抗生素相结合，创造了一种新的产品，满足了一个重要的未满足的医疗需求。目前的局部眼部抗生素需要24小时给药。除了不方便，如果使用不当，今天呢？滴眼液可能导致持续的眼睛创伤/损伤，效果不理想，并造成相当大的浪费。交联的，可调的？电影吗?由专业医疗人员申请？含有一种经商业验证的抗生素，可在数天内以精确的数量释放到眼表，无需患者进一步自行给药。在补助金中？第一阶段，生产了含有抗生素的HA原型膜，进行了灭菌，并成功地在体外和体内测试了药物释放和耐受性。第二阶段将包括形状开发，配方/药物释放优化，体内药物含量释放确认，以及无菌货架稳定膜的可靠制造工艺的开发。本II期研究的目标是继续优化和开发无菌抗生素释放交联透明质酸薄膜，用于局部眼表治疗威胁视力的角膜溃疡。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to more effectively treat serious, infectious corneal ulcers by delivering antibiotics directly to the eye?s surface via a novel, biodegradable flexible polymer film. The platform will deliver drug continuously, thereby eliminating the need for hourly eye drops. This product can be administered immediately, at time of injury, allowing health professionals to ensure best treatment and outcomes. The platform solves immediate unmet medical needs in corneal infections, which are a result of improper contact lens wear, as well as increased incidence of eye trauma in the US military. Worldwide, corneal ulcers commonly result in blindness due to difficulty in obtaining and applying medication. These antibiotic-containing films ? which combine polymer science, chemical bioengineering, and drug pharmaceutical formulation innovation ? will bring improved commercially available solutions to vision-threatening conditions far beyond corneal ulcers by employing this novel platform, which provides an effective, easy-to-administer, broad application of sustained, local ophthalmic drug delivery. Broader societal impact lies in the scientific and technical discoveries and innovation, as well as the ability to educate/train others on advances in polymer drug delivery science. The proposed product is based on a proprietary, cross-linked hyaluronic acid (HA) polymer technology, formulated with antibiotics to deliver drug locally and continuously to the ocular surface over multiple days. The well established healing effects of HA, combined with continual-release antibiotics create a novel product that fulfills a significant unmet medical need. Current topical ocular antibiotics require round-the-clock dosing. In addition to being inconvenient, if administered incorrectly, today?s eye drops can lead to continued eye trauma/damage, less-than-optimum outcomes, and considerable waste. The cross-linked, ?tunable? film ? applied by a medical professional ? contains a commercially proven antibiotic that is released over multiple days in precise quantities to the ocular surface with no further patient self-dosing required. In the grant?s Phase I, prototype HA films containing antibiotics were produced, sterilized, and successfully tested in vitro and in vivo for drug release and tolerability. Phase II will include shape development, formulation/drug-release optimization, drug content release confirmation in vivo, and development of a reliable manufacturing process for sterile shelf-stable films. The objective of this Phase II proposal is to continue to optimize and develop sterile antibiotic-releasing cross-linked HA films to be applied locally to the ocular surface to treat sight-threatening corneal ulcers.