Development of a women-centric gynaecological drug delivery device to improve psychosocial and physical wellbeing during treatment for miscarriage & pre-term birth prevention, and IVF

开发以女性为中心的妇科给药装置，以改善流产治疗期间的心理社会和身体健康

• 批准号: 10054614
• 金额: $ 89.04万
• 依托单位: CALLA LILY CLINICAL CARE LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10054614
• 关键词: Development; women; centric; gynaecological; drug

Calla Lily Clinical Care (CLCC) is an ambitious British startup that has successfully invented a novel hybrid tampon and pantyliner that can be designed in such a way that it delivers drugs to a woman's vagina when in place.The current way of delivering drugs to the vagina is to use a pessary, but these are inconvenient, unhygienic, prone to movement such that women report being highly anxious during this stressful time i.e. these treatments are typically used during fertility treatment or to prevent miscarriage or premature births. CLCC's device, called a Tampliner, was invented by a leading gynaecologist and is more convenient to use with enhanced leakage protection and features a thin "sheath" to provide a cleaner and convenient user experience.CLCC has produced small quantities of this device that have been successfully evaluated in basic laboratory tests. The business has then protected the idea with a number of granted patents in various key markets (including the US/EU). The next key stage, and focus of the enclosed funding request, is to move to the next level and develop a device that is loaded with an actual drug that can then be tested in laboratory conditions to ensure it correctly releases the drug as required. Once this work is completed, CLCC will be in a position to proceed with trials of the device with female volunteers.This project is focused on the following goals.* **Drug Development**: develop how the drug (in this case hormone progesterone) is mixed or formulated with other drug components so that it is released into the body in the correct way.* **Laboratory Feasibility Testing**: Drug release profile testing, biocompatibility and sterility testing, functional/mechanical testing, and other evaluation of the finalised prototypes.* **Product Claim Validation**: Pilot in vivo study to validate product claims by measuring drug levels in the blood and observing leakage against current method (control).Through this project, CLCC will collaborate with experts in drug delivery, materials science and pharmacology, internationally-renowned gynaecologists, and a leading biopharmaceutical laboratory to help us with the development of this drug delivery device.

Calla Lily Clinical Care（CLCC）是一家雄心勃勃的英国初创公司，成功发明了一种新颖的混合型内裤和内裤护垫，可以设计成在到位时将药物输送到女性阴道，目前将药物输送到阴道的方式是使用子宫托，但这些都不方便，不卫生，倾向于运动，使得妇女报告在这段紧张的时间内高度焦虑，即这些治疗通常在生育治疗期间使用或用于防止流产或早产。CLCC的设备被称为Tampliner，由一位领先的妇科医生发明，使用起来更方便，具有增强的泄漏保护，并具有薄的“护套”，提供更清洁和方便的用户体验。CLCC已经生产了少量的这种设备，并在基本的实验室测试中成功评估。该公司随后在多个关键市场（包括美国/欧盟）通过多项授权专利保护了这一想法。下一个关键阶段，也是所附资金申请的重点，是进入下一个阶段，开发一种装有实际药物的设备，然后可以在实验室条件下进行测试，以确保它能按要求正确释放药物。一旦这项工作完成，CLCC将能够在女性志愿者中进行该设备的试验。该项目的重点是以下目标。* ** 药物开发 **：开发如何药物（在这种情况下，激素孕酮）与其他药物成分混合或配制，以便以正确的方式释放到体内。** 实验室可行性测试 **：药物释放曲线测试、生物相容性和无菌性测试、功能/机械测试以及最终原型的其他评估。**Product Claim Validation**：通过测量血液中的药物浓度并观察当前方法（对照）的泄漏情况来验证产品声明的体内试验研究。通过该项目，CLCC将与药物输送，材料科学和药理学专家，国际知名的妇科医生和领先的生物制药实验室合作，帮助我们开发这种药物输送装置。