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.
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 suspension products, an excess amount of compound has to be applied with only a small portion of dissolved active pharmaceutical ingredient (API), thus, a reduction of the total dose may be possible in Marinosolv® formulations.
- Using suspensions, improper dosing may occur due to patients often forget to shake the product prior to use.
- Aseptic production by sterile 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 of 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, a nasal spray dosage form with solubilized budesonide for treatment of allergic rhinitis, was successfully finished and the publication can be found here. The study validated the Marinosolv® platform. The Company also develops an ophthalmic formulation on the basis of fully solubilized tacrolimus, preclinical data have been published. A phase II clinical trial for dose finding has been performed, please find first topline results here.
The technology is not limited to a specific compound and has the potential to facilitate delivery of potentially any API with solubility issues. Compound classes already tested with MARINOSOLV® include macrolide immunosuppressants such as Tacrolimus or Cyclosporine A as well as steroids such as budesonide and fluticasone propionate.
Yes. Marinosolv® has been demonstrated to be clinically compatible with applications in eyes and nose. It provides a non-irritating, safe and effective way to deliver hardly soluble active compounds to local tissues. An excellent tolerability could also be shown in a preclinical in-vivo setting at systemic oral and intravenous application of a target API.