Project description
CNS drug administration via the nasal cavity
The treatment of central nervous system (CNS) disorders such as multiple sclerosis remains a significant medical challenge because most drugs including antibodies fail to cross the blood brain barrier (BBB) effectively. Administration of drugs via the nasal route reaches the CNS bypassing the BBB offering a promising and non-invasive strategy for treating CNS disorders. The EU-funded N2B-patch project aims to develop an innovative medical device to facilitate drug administration via the nasal cavity. The device will consist of biodegradable polymer particles embedded in a hydrogel matrix. The drug-loaded formulation will provide a pH-sensitive coating to ensure specific adhesion to the olfactory epithelium and increase drug bioavailability to the CNS.
Objective
The overall aim of N2B-patch is the development of a new innovative N2B drug delivery technology based on the synthesis of a biomaterial-based innovative galenic formulation that will be applied with the aid of a novel medical device equipped with a container closure system (CCS) as a hydrogel patch to the nasal olfactory region for the chronic treatment of MS. The galenic formulation will consist of drug loaded biodegradable polymer particles (e.g. chitosan, polylactic-co-glycolic acid, PLGA) embedded into a biodegradable hydrogel matrix (e.g. hyaluronic acid (HA)-based) to be deposited as a patch onto the olfactory region. A pH-sensitive, mucoadhesive particle coating (e.g. chitosan, chitosan derivatives) will ensure an environment-specific adhesion to the olfactory epithelium. This novel technology will largely enhance the controlled and sustainable delivery of drugs and increase the drug bioavailabilty to the CNS. NogoA antagonist NG-101 will be used as an active pharmaceutical ingredient (API). Proof of concept studies and initial clinical data have proven the enormous potential of blocking NogoA for spinal cord remyelation and axonal integrity. However, monoclonal antibodies (mAb) like NG-101, do not sufficiently cross the BBB. The sustainable and controlled release of NG-101 to the CNS will be achieved via the transport of embedded polymer particles to the olfactory epithelium, the subsequent release of API and permeation through the olfactory region, the only part of the nasal epithelium which is in direct contact with the brain. The direct transport route from the nasal cavity to the brain, bypassing the BBB, offers an exciting mode of central nervous system (CNS) drug delivery not only for demyelinating disorders but also for other CNS indications, e.g. stroke, neurodegenerative diseases or tumours. The proposed new innovative N2B drug delivery platform is a practical, safe, and minimally invasive technology. It will be exploited for NG-101 and has the potential to be implemented with other APIs with a low CNS bioavailability.
Fields of science
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesbasic medicineneurologymultiple sclerosis
- medical and health sciencesbasic medicinepharmacology and pharmacypharmacokinetics
- medical and health sciencesbasic medicineneurologystroke
- medical and health sciencesmedical biotechnologyimplants
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
80686 Munchen
Germany