A novel, safe and resistance-free treatment of vaginal candida infections
|Coordinator||GEDEA BIOTECH AB|
|Funding from Vinnova||SEK 1 000 000|
|Project duration||November 2017 - June 2018|
Purpose and goal
The goal of the project - to further develop the formulation of the selected vaginal tablet prototype, verify its safety in biological tests, and analyse technical stability - has been achieved. Furthermore, the product value chain has been validated through interviews with pharmacy chains, wholesalers and distributors. The company is now preparing to apply for a clinical trial, which is the next milestone.
Expected results and effects
The aim of the project was to further develop the formulation, produce vaginal tablets for analysis of 1 and 3 month technical stability, evaluate biological safety and validate the value chain for the product. The result shows that the blister pack selected for the clinical batches meets the requirements for stability and that the vaginal tablet does not show any signs of irritation or sensitisation in biological tests. Information about stakeholder requirements, costs and time plans has been obtained in the value chain work.
Planned approach and implementation
The selected vaginal tablet prototype from the phase I project has been further developed in collaboration with Galenica AB. A final composition has been selected, manufactured and analyzed for stability in two different blister packs. A final blister pack has been selected based on stability data. Biological tests of the final vaginal tablet have been conducted in cooperation with Eurofins Medical Device Testing and the safety of vaginal tablets has been validated. The project has thus been implemented in accordance with the project outline.