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

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力将是通过将抗生素直接输送到眼睛来更有效地治疗严重的感染性角膜溃疡？的表面通过一种新的，可生物降解的柔性聚合物薄膜。该平台将连续输送药物，从而无需每小时滴一次眼药水。该产品可以在受伤时立即使用，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中未得到满足的医疗需求，这是由于不正确的接触透镜佩戴以及美国军队中眼外伤发病率增加造成的。在世界范围内，由于难以获得和应用药物，角膜溃疡通常导致失明。这些含有杀虫剂的胶片？它结合了联合收割机聚合物科学、化学生物工程和药物制药配方创新。将通过采用这种新的平台为远超过角膜溃疡的威胁视力的病症带来改进的市售解决方案，其提供了持续的局部眼科药物递送的有效、易于施用、广泛应用。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/培训他人在聚合物药物输送科学的进步的能力。申报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，可在多天内将药物局部持续递送至眼表。HA与持续释放抗生素结合的良好愈合效果创造了一种新产品，可满足重大未满足的医疗需求。目前的局部眼部抗生素需要全天候给药。除了不方便，如果管理不当，今天？滴眼液可能导致持续的眼外伤/损伤、不太理想的结果和相当大的浪费。交联的，？可调的？电影？是由医学专业人士申请的吗含有一种经过商业验证的抗生素，该抗生素在多天内以精确的量释放到眼表面，而无需进一步的患者自我给药。在补助金里？的第一阶段，原型HA薄膜含有抗生素的生产，灭菌，并成功地在体外和体内测试的药物释放和耐受性。第二阶段将包括形状开发、处方/药物释放优化、体内药物含量释放确认以及无菌货架稳定薄膜的可靠生产工艺开发。本II期提案的目的是继续优化和开发无菌的释药交联HA薄膜，用于局部应用于眼表，以治疗危及视力的角膜溃疡。

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.