A new condom design for encouraging correct and consistent use

摘要 缺乏足够的润滑是坚持和正确使用避孕套的一个主要普遍缺点。 因此，避孕套使用不当会增加包括艾滋病毒在内的性传播感染的风险。 润滑不足的避孕套也会导致粘膜微创伤、疼痛，增加避孕套脱落的机会 夫妻之间的感情破裂和满意度下降。HydroGlyde涂层解决了这些问题 通过提供用水激活的不间断的上级润滑， 需要额外的润滑来保持避孕套的润滑性。我们希望我们的新自我- 润滑涂层技术将：1）改变社会对使用避孕套的负面污名; 2）鼓励 正确和一致的避孕套使用和使用意愿; 3）减少粘膜微创伤; 4）减少 意外怀孕和性传播感染和性传播疾病的传播; 5）提高用户满意度。我们已经开发 并对乳胶避孕套的HydroGlyde涂层进行了表征，并进行了IRB批准的触摸- 一项测试调查发现，人类受试者对HydroGlyde涂层避孕套的偏好超过非润滑避孕套 乳胶样品或KY® Liquid润滑样品。这些结果反映了普通民众的利益 在这项技术中，提供乐观的意愿，接受HydroGlyde涂层避孕套，如果介绍给 市场我们的目标是制造HydroGlyde涂层原型和涂层应用程序， 适应GMP标准下的大规模生产。我们将与Biocoat Inc.和 波士顿大学完成以下目标： 具体目标1：HydroGlyde涂层技术原型和应用过程的过渡 根据Biocoat Inc.的涂层专业知识， 具体目标2：（a）评估植入物的物理、生物相容性、机械和耐久性 HydroGlyde涂层男性乳胶避孕套与市售润滑剂的比较， 润滑的避孕套;（B）在上皮细胞系中研究潜在可降解物的体外细胞毒性 通过MTS transwell分析 发展规划成功完成这些目标对于第二阶段SBIR应用至关重要， 将重点关注：1）TOXICON的生物相容性和安全性研究; 2）ISO测试; 3）加速稳定性和 有效期研究;和4）在GPC/Karax Berhad根据GLP进行包装。

Abstract The lack of adequate lubrication is a major universal drawback for consistent and correct condom use. Consequently, improper condom usage leads to increased risks for the spread of STIs, including HIV. Inadequately lubricious condoms can also result in mucosal microtrauma, pain, increased chances of condom breakage, and decreased satisfaction between partners. The HydroGlyde Coating addresses these issues by providing uninterrupted superior lubrication that is activated with water thereby eliminating the need for additional lubrication to maintain the condom's lubricity. We expect that our novel self- lubricating coating technology will: 1) alter the negative societal stigma regarding condom usage; 2) encourage correct and consistent condom use and usage desirability; 3) reduce mucosal microtrauma; 4) decrease unwanted pregnancies and spread of STIs and STDs; and, 5) improve user satisfaction. We have developed and characterized the HydroGlyde Coating for latex condoms, as well as performed an IRB-approved touch- test survey which found human subject preference for the HydroGlyde coated condoms over non-lubricated latex samples or samples lubricated with KY® Liquid. These results projected the general population's interests in this technology, providing optimistic willingness to accept HydroGlyde coated condoms if introduced to the market. Our goal is to fabricate the HydroGlyde Coating prototype and coating application procedure to be adaptable towards large-scale manufacturing under GMP standards. We will collaborate with Biocoat Inc. and Boston University to complete the following aims: SPECIFIC AIM 1: Transition of the HydroGlyde Coating technology prototype and application process on male latex condoms to an industrial prototype under the coating expertise of Biocoat Inc. SPECIFIC AIM 2: (a) Assess the physical, biocompatible, mechanical, and durability properties of the HydroGlyde coated male latex condoms in comparison to commercially available lubrications and lubricated condoms; (b) investigate in vitro cytotoxicity of potential leachables in an epithelial cell line via an MTS transwell assay Development Plan. Successful completion of these aims will be critical for a Phase II SBIR application which will focus on: 1) biocompatibility and safety studies at TOXICON; 2) ISO testing; 3) accelerated stability and shelf-life studies; and 4) packing under GLP at GPC/Karax Berhad.