Description du projet
Administration, via la cavité nasale, de médicaments pour le SNC
Le traitement des troubles du système nerveux central (SNC) tels que la sclérose en plaques demeure un défi médical de taille dans la mesure où la plupart des médicaments, y compris les anticorps, ne parviennent pas à traverser de manière efficace la barrière hémato-encéphalique (BHE). L’administration de médicaments par voie nasale atteint le SNC en contournant la BHE, ce qui constitue une stratégie prometteuse et non invasive pour le traitement des troubles du SNC. Le projet N2B-patch, financé par l’UE, entend développer un dispositif médical innovant qui facilitera l’administration de médicaments par la cavité nasale. Le dispositif sera constitué de particules de polymères biodégradables intégrées dans une matrice d’hydrogel. La formulation contenant le médicament fournira un revêtement sensible au pH pour assurer une adhésion spécifique à l’épithélium olfactif et augmenter la biodisponibilité du médicament pour le SNC.
Objectif
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.
Champ scientifique
- 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
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Régime de financement
RIA - Research and Innovation actionCoordinateur
80686 Munchen
Allemagne