Combined Hydrogel/Microparticle Eye Drops for Sustained Delivery of Glaucoma Medication

用于持续输送青光眼药物的组合水凝胶/微粒滴眼剂

基本信息

  • 批准号:
    8817604
  • 负责人:
  • 金额:
    $ 32.69万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2014
  • 资助国家:
    美国
  • 起止时间:
    2014-12-01 至 2019-11-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Combined Hydrogel/Microparticle Eye Drops for Sustained Delivery of Glaucoma Medication Glaucoma is the second leading cause of blindness worldwide and costs $2.5B to treat every year in the US alone. Topical eye drops are the current clinical standard in treating glaucoma and numerous other ocular pathologies. However, the frequent and difficult administration of eye drops makes them highly inefficient, with patient compliance in some cases as low as 50%. Poor compliance puts patients at risk for worsening vision and blindness, with a significant increase in treatment costs. Both patients and clinicians would benefit greatly from a more efficient treatment method that would increase patient compliance and deliver drug more efficiently to the aqueous humor to avoid systemic toxicity. Contact lenses and novel eye drops including nanoparticles are a comfortable and familiar alternative to traditional eye drops, but have only extended delivery windows to several hours or days at most. In contrast, formulations that can provide weeks to months of drug release currently require injection or implantation into the eye by a clinician. If an ocular deliery strategy could combine the comfort and simplicity of an eye drop with long-term drug delivery, it could revolutionize the delivery of not only glaucoma medication, but other ocular medications as well. The goal of this project is to develop a new, easy-to-administer, and noninvasive treatment capable of long- term release of glaucoma medication to the eye. Such a formulation would dramatically reduce patient compliance-related complications due to the simple, patient-administered format and the marked decrease in dosing frequency. The consequences of systemic toxicity and insufficient ocular absorption inherent to eye drops would be mitigated with a more direct delivery of over 100x less drug. Using a combined approach of highly customizable, polymer microparticle (MP)-controlled delivery of brimonidine tartrate (BT) contained in an in situ forming gel eye drop will provide a comfortable and vastly more efficient delivery format for the treatment of glaucoma. The gel eye drop is intended for administration to the lower fornix, where it comfortably conforms to the conjunctival cul-de-sac and releases drug for up to 30 days. The project's primary objective is to optimize custom-designed MPs to release therapeutic levels of BT and engineer a thermoresponsive, hydrogel matrix for retaining the MPs. In silico modeling methods will be used to develop the drug delivery system, followed by requisite in vitro validation of drug release kinetics. The gel/MP system will be tested in a rabbit model of ocular hypertension to demonstrate clinically relevant results and sustained BT delivery. Finally, this new drug delivery system will be evaluated as a platform for treating othe ocular diseases by using noninvasive magnetic resonance imaging (MRI) to monitor drug release and distribution in vivo. Ultimately, this work represents the initiation of preclinical efficacy and safety testing of a modular strategy for delivering of a variety of ocular therapeutic using novel in vivo drug delivery and visualization techniques.
描述(由申请人提供):用于持续递送青光眼药物的组合水凝胶/微粒滴眼液 青光眼是全球第二大致盲原因,仅在美国每年治疗费用就达25亿美元。 局部滴眼液是目前治疗青光眼和许多其他眼部病变的临床标准。 然而,频繁且困难的滴眼液给药使其效率极低,在某些情况下患者依从性低至50%。 依从性差会使患者面临视力恶化和失明的风险,治疗费用也会显著增加。 患者和临床医生都将极大地受益于更有效的治疗方法,该治疗方法将增加患者的依从性并将药物更有效地递送到房水以避免全身毒性。 隐形眼镜和包括纳米颗粒的新型滴眼液是传统滴眼液的舒适和熟悉的替代品,但最多只能将递送窗口延长至几小时或几天。 相比之下,可以提供数周至数月的药物释放的制剂目前需要由临床医生注射或植入眼中。 如果一种眼部给药策略可以将联合收割机的舒适性和简单性与长期药物输送相结合,它不仅可以彻底改变青光眼药物的输送,还可以改变其他眼部药物的输送。 该项目的目标是开发一种新的,易于管理的,非侵入性的治疗方法,能够长期释放青光眼药物到眼睛。 由于简单的患者给药形式和给药频率的显著降低,这种制剂将显著降低患者依从性相关的并发症。 滴眼液固有的全身毒性和眼部吸收不足的后果将通过更直接地递送超过100倍的药物来减轻。 使用高度可定制的、聚合物微粒(MP)控制的酒石酸溴莫尼定(BT)的递送的组合方法,所述酒石酸溴莫尼定(BT)包含在原位形成的凝胶滴眼剂中,这将为青光眼的治疗提供舒适且大大更有效的递送形式。 该凝胶滴眼液预期用于下穹窿给药,使其舒适地贴合结膜盲囊,并释放药物长达30天。 该项目的主要目标是优化定制设计的MP,以释放治疗水平的BT,并设计用于保留MP的温敏水凝胶基质。 将使用计算机模拟方法开发药物递送系统,然后进行必要的药物释放动力学体外验证。 凝胶/MP系统将在兔高眼压模型中进行测试,以证明临床相关结果和持续的BT输送。 最后,我们将利用无创磁共振成像(MRI)监测药物在体内的释放和分布,评估这种新型药物递送系统作为治疗其他眼部疾病的平台。 最终,这项工作代表了使用新型体内药物递送和可视化技术递送各种眼部治疗药物的模块化策略的临床前有效性和安全性测试的开始。

项目成果

期刊论文数量(0)
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STEVEN R LITTLE其他文献

STEVEN R LITTLE的其他文献

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{{ truncateString('STEVEN R LITTLE', 18)}}的其他基金

Combined Hydrogel/Microparticle Eye Drops for Sustained Delivery of Glaucoma Medication
用于持续输送青光眼药物的组合水凝胶/微粒滴眼剂
  • 批准号:
    9186545
  • 财政年份:
    2014
  • 资助金额:
    $ 32.69万
  • 项目类别:
Treatment of Periodontitis via Recruitment of Regulatory Lymphocytes
通过招募调节性淋巴细胞治疗牙周炎
  • 批准号:
    8522273
  • 财政年份:
    2011
  • 资助金额:
    $ 32.69万
  • 项目类别:
Treatment of Periodontitis via Recruitment of Regulatory Lymphocytes
通过招募调节性淋巴细胞治疗牙周炎
  • 批准号:
    8321474
  • 财政年份:
    2011
  • 资助金额:
    $ 32.69万
  • 项目类别:
Treatment of Periodontitis via Recruitment of Regulatory Lymphocytes
通过招募调节性淋巴细胞治疗牙周炎
  • 批准号:
    8723640
  • 财政年份:
    2011
  • 资助金额:
    $ 32.69万
  • 项目类别:
Treatment of Periodontitis via Recruitment of Regulatory Lymphocytes
通过招募调节性淋巴细胞治疗牙周炎
  • 批准号:
    8108000
  • 财政年份:
    2011
  • 资助金额:
    $ 32.69万
  • 项目类别:
Resolution and Regeneration in Periodontitis via Recruitment of Regulatory Lympho
通过招募调节性淋巴细胞来解决牙周炎并使其再生
  • 批准号:
    8112200
  • 财政年份:
    2010
  • 资助金额:
    $ 32.69万
  • 项目类别:

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