N2B-Patch – Development of an intranasal form of therapy for the treatment of multiple sclerosis

Biomaterials for treatment of demyelination disorders of the central nervous system

In January 2017, the N2B-patch project "Nose to Brain Delivery of an API via the Olfactory Region for the Regenerative Treatment of Multiple Sclerosis Using Novel Multifunctional Biomaterials Combined with a Medical Device" coordinated by Fraunhofer IGB started its four-year research plan. The aim is to develop an intranasal application platform for biopharmaceuticals that affect the central nervous system. To do so, an innovative galenical formulation based on biomaterials is to be combined with a special applicator and applied as a hydrogel bandage on the olfactory epithelium as a therapy for multiple sclerosis.

Flow-through cell
© Fraunhofer IGB

Flow-through cell for determination of drug release according to USP 4.

chitosan particles
© Fraunhofer IGB

Cross-linked chitosan particles for long-term release.

Acting as project coordinator as part of the EU-funded joint project “N2B-patch”, Fraunhofer IGB is involved in the development of a medicine-based treatment form for drug delivery over the regio olfactoria. At this position, the brain and the fluids surrounding it are separated from the nasal cavity by only the ethmoid bone and a few layers of cells. For many diseases – for example, of the central nervous system – it is crucial to transport the active substance to the desired target site in the most efficient way possible. One example of this is the treatment of multiple sclerosis, where the active substances must exert their effects predominantly on the central nervous system (CNS).

The goal is to develop an intranasal application platform for CNS-active biopharmaceuticals. Within the project, Fraunhofer IGB concentrates on the formulation of particles containing the active substance, and the embedding of these into hydrogels.

The development of a new form of therapy usually requires several years of intensive research and validation. The N2B-patch team starts its work in the laboratory and ends in proof of concept and pre-clinical validation. A total of eleven project partners from research and industry are participating in the project, which started at the beginning of 2017 and has financial backing for four years. The project partners are primarily focusing their research on the treatment of multiple sclerosis but they also hope to open up further fields of application of the N2B-platform.

Project information

Project title

N2B-Patch – Nose to Brain Delivery of an API via the Olfactory Region for the Regenerative Treatment of Multiple Sclerosis Using Novel Multifunctional Biomaterials Combined with a Medical Device

 

Project duration

January 2017 – December 2020

 

Project partners

  • Fraunhofer IGB, coordination
  • Contipro a.s. (Czech Republic)
  • MJR PharmJet GmbH (Germany)
  • Fachhochschule Biberach (Germany)
  • Centre for Research and Technology Hellas - CERTH (Greece)
  • Beiter GmbH & Co. KG (Germany)
  • Laboratorio Europeo di Spettroscopie Non Lineari (Italy)
  • JensonR+ Limited (United Kingdom)
  • LGI Consulting Sàrl (France)
  • The European Multiple Sclerosis Platform aisbl (Belgium)
  • NovaGo Therapeutics AG (Switzerland)

Funding

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 721098.