MARINOSOLV® is a technology platform enabling novel aqueous formulations of hardly soluble compounds (patent pending). It increases the solubility of a water-insoluble or hardly water-soluble hydrophobic organic compound in an aqueous formulation. Improving stability of organic compounds is of great interest in the pharmaceutical industry. Especially in the field of respiratory diseases and treating medical conditions concerning the mucous membranes of the respiratory tract, aqueous solutions are a desired delivery method as opposed to powders, suspensions or aerosols.
In general, dissolved compounds may have the following advantages towards suspensions:
- Increase of bioavailability in the target tissue.
- Faster onset of action compared to suspensions due to higher bioavailability.
- In currently marketed products, exemplified by intranasal steroids, an excess of compound is applied compared to the dissolved proportion of the active pharmaceutical ingredient (API), thus, a reduction of the total dose may be possible.
- With suspensions, improper dosing may occur because patients often forget to shake the product.
- Aseptic production with filtration may be possible and preservatives may be omitted.
- Combination with other active pharmaceutical ingredients (API) may be easier to achieve.
- Potential for cost of goods (COGS) reduction based on cheaper production processes.
- Patent protection may be achieved for MARINOSOLV® based formulations with compounds that are off-patent otherwise.
- New applications for highly insoluble substances in eyes, lungs, other mucosal tissues, or elsewhere are feasible which may result in low systemic availability and high local activity.
Yes. A pivotal phase III clinical study on Budesolv was successfully finished in 2019 and the publication can be found here. The study validated the MARINOSOLV® platform. The Company has already initiated clinical trials with Tacrosolv.
Compound classes tested with MARINOSOLV® include macrolide immunosuppressants such as Tacrolimus or Cyclosporine A as well as steroids such as budesonide and fluticasone propionate. The technology is not limited to a specific compound and has the potential to facilitate delivery of potentially any API with solubility issues.
Yes. MARINOSOLV® is compatible with applications in eyes and nose. It provides a non-irritating, safe and effective way to deliver hardly soluble active compounds to the nasal mucosa and eyes.