Overcoming pre-clinical challenges for a next-generation gynaecological drug delivery device which maximises patient comfort and convenience

卡拉利是一家雄心勃勃的英国初创公司，它成功地开发出了几十年来对女性的首项重大创新并将其商业化：一种新颖的“混合”内裤和内裤衬垫，这是一位英国资深妇科医生的创意。被称为一个坦普尔（R），已经多次获奖的产品包括增强泄漏预防性能和薄“鞘”，提供了一个更清洁和舒适的用户体验。去年，卡拉利在英国建立了Tampliner的生产基地，并在英国和西欧成功地开展了商业销售。除了作为经期护理产品之外，Tampliner还被卡拉利团队和领先的妇科关键意见领袖确定为清洁、舒适和方便的阴道药物输送的潜在平台。这一概念已在多个主要市场（包括美国和欧盟）获得专利保护。具体应用是用于体外受精（IVF）的孕酮输送，因为与目前规定的混乱、不舒服、有时甚至痛苦的选择相比，用户体验可以得到极大的改善。为了进一步开发重新设计用于输送激素的Tampliner的巨大潜力，卡拉利必须完成一个强大而详细的可行性项目。卡拉利需要克服许多挑战，这份随附的Smart Grant申请帮助团队通过实现以下关键目标来开发作为药物输送设备的Tampliner：* 药物释放涂层和支架制造：** 选择最佳支架材料，研究药物制剂涂层方法（即喷涂、浸渍、干燥）以最大限度地提高输送的可行性，并制造最终原型用于实验室测试。* ** 实验室可行性试验：** 药物释放曲线试验（HPLC）、生物相容性和无菌性试验、功能/机械试验以及根据PRS对最终原型进行的其他评价。* ** 法规和临床开发路径：** 基于上述策略，咨询专家分包商，以确定IVF适应症的最佳法规和临床批准策略。通过该项目，卡拉利将与药物输送，材料科学和药理学专家，国际知名妇科医生和领先的生物制药实验室合作，以验证该药物输送装置的可行性。

Callaly is an ambitious British startup that has successfully developed and commercialised the first major innovation to the tampon in decades: a novel "hybrid" tampon and pantyliner that is the brainchild of a senior British gynaecologist. Called a Tampliner(R), the already multi award-winning product includes enhanced leakage prevention properties and a thin "sheath" that provides a more clean and comfortable user experience. Callaly established UK based manufacturing of the Tampliner last year and has successfully launched commercial sales in the UK and Western Europe.Beyond the use as a period care product, the Tampliner has been identified by the Callaly team and leading gynaecological key opinion leaders as a potential platform for clean, comfortable and convenient vaginal drug delivery. This concept has already been protected with granted patents in various key markets (including the US and EU). The specific application is for the delivery of progesterone for in-vitro fertilisation (IVF) as the user experience can be drastically improved compared to the messy, uncomfortable, and sometimes painful options that are currently prescribed.To further develop the vast potential of the Tampliner re-engineered for the delivery of hormones, Callaly must complete a robust and detailed feasibility project. There are numerous challenges for Callaly to overcome, and this enclosed Smart Grant application helps the team develop the Tampliner as a drug delivery device by achieving these key objectives:* **Drug Release Coating & Scaffold Fabrication:** Select best scaffold material, investigate drug formulation coating methods (i.e. spray, dip, dry) to maximise the viability of the delivery, and fabricate finalised prototypes for laboratory testing.* **Laboratory Feasibility Testing:** Drug release profile testing (HPLC), biocompatibility and sterility testing, functional/mechanical testing, and other evaluation of the finalised prototypes against the PRS.* **Regulatory & Clinical Development Pathway:** Based on the above strategy, consult with expert subcontractors to determine the best regulatory & clinical approval strategy for the IVF indication.Through this project, Callaly will collaborate with experts in drug delivery, materials science, and pharmacology, internationally renowned gynaecologists, and a leading biopharmaceutical laboratory to validate the feasibility of this drug delivery device.