Cornelia Siegl

Marinomed Biotech AG, Austria

Title: Marinosolv® - The technology platform for novel aqueous formulations

---

Biography

Dr. Cornelia Siegl is project manager at Marinomed Biotech AG since 2015 and has since then concentrated on the development of the Marinosolv technology platform, and thereby creating an IP protection of the technology, in a companywide teamwork. Her primary objectives were focused on solubility and stability studies of well-known active product ingredients, that are currently marketed as suspension, due to their low water solubility and / or their poor stability in aqueous formulations. Some of these substances were then chosen for a potential product development for a dedicated indication, resulting in formulation development for clinical phases. During clinical development and for market product development she is responsible for manufacturing process development and validation together with and at the CDMO´s.

Abstract

Marinosolv is an IP protected technology platform which allows the solubilization of a wide series of insoluble drugs, such as the corticosteroids budesonide or fluticasone propionate or macrolide immunomodulators such as tacrolimus. Those compounds are currently only be delivered as a suspension, due to their low water solubility. The technology enables novel aqueous formulations with applications in sensitive tissue such as nose, eyes and lungs. Dissolved drugs permeate faster into nasal and/or oral mucosa, as well as into ocular compartments such as cornea and conjunctiva, facilitating efficient drug delivery and a faster onset of action. Furthermore, the improved bioavailability may result in reduced dose application.

Several ex-vivo studies of fluorescently labeled estradiol dissolved in Marinosolv, developed as model compound, showed remarkable amounts of estradiol in porcine cornea compared to estradiol formulated as suspension. Furthermore, in-vivo studies in pigs were performed on tacrolimus, developed as topical non-steroidal treatment option for anterior and posterior eye diseases, called Tacrosolv. Tacrolimus dissolved in Marinsolv showed a concentration-dependent increased permeation into porcine cornea, choroidea and retina when dissolved in Marinosolv compared to topical application of suspensions or oral treatment. We developed further an aqueous nasal formulation of budesonide, based on the Marinosolv technology called Budesolv, for the indication of J Pain Relief, ISSN: 2167-0846 JPAR an open access journa, Fibromyalgia 2016, June 15-16, 2016, Volume 5, Issue 3(Suppl), Page 40 allergic rhinitis. The anti-inflammatory activity of Budesolv was characterized in vivo in BALB/c mice, in comparison to CD-solubilized budesonide and the commercial product Rhinocort® aqua 64 micrograms, nasal spray. Both Tacrosolv and Budesolv were proven in-vivo on their local tolerance for their intended application.

Preclinical results were recently verified in a pivotal challenge chamber study designed to demonstrate efficacy and onset of action exposing allergic subjects to grass pollen thereby inducing symptoms. Results demonstrated that Budesolv can effectively control AR nasal symptoms and demonstrated clinical benefit after the first Budesolv treatment on Day 1.