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

马蹄莲临床护理（CLCC）是一家雄心勃勃的英国初创公司，它成功地发明了一种新型的混合卫生棉条和内裤衬垫，可以设计成在适当的时候将药物输送到女性的阴道。目前将药物输送到阴道的方法是使用子宫托，但这些方法不方便、不卫生、容易移动，因此妇女报告说，在这段紧张的时间里，这些治疗方法通常用于生育治疗或防止流产或早产。CLCC的设备，被称为Tampliner，是由一位领先的妇科医生发明的，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已经生产了少量这种装置，并在基本实验室测试中成功地进行了评估。随后，该公司在多个主要市场（包括美国/欧盟）获得了多项授权专利，保护了这一创意。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，开发一种装载实际药物的设备，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。该项目主要关注以下目标。** *药物开发**：开发药物（在本例中为黄体酮激素）如何与其他药物成分混合或配制，以使其以正确的方式释放到体内。** *实验室可行性测试**：药物释放测试、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。** *产品声明验证**：通过测量血液中的药物水平和观察当前方法（对照）的泄漏来验证产品声明的体内试验研究。通过这个项目，CLCC将与药物输送、材料科学和药理学方面的专家、国际知名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。

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.