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

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.