Descrizione del progetto
Somministrare farmaci al sistema nervoso centrale attraverso la cavità nasale
Il trattamento dei disturbi del sistema nervoso centrale (SNC), come la sclerosi multipla, costituisce tuttora una sfida medica significativa in quanto la maggior parte dei farmaci, compresi gli anticorpi, non riesce ad attraversare in modo efficace la barriera ematoencefalica. La somministrazione di farmaci per via nasale raggiunge il SNC aggirando tale barriera, una soluzione che offre una strategia promettente e non invasiva per il trattamento dei disturbi che colpiscono questo sistema. Il progetto N2B-patch, finanziato dall’UE, si prefigge di facilitare la somministrazione di farmaci attraverso la cavità nasale mediante lo sviluppo di un dispositivo medico innovativo, costituito da particelle polimeriche biodegradabili integrate all’interno di una matrice di idrogel. La formulazione carica di farmaco sarà caratterizzata da un rivestimento sensibile al pH per garantire un’adesione specifica all’epitelio olfattivo e aumentare la biodisponibilità del farmaco al sistema nervoso centrale.
Obiettivo
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.
Campo scientifico
- 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
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-NMBP-2016-two-stage
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
80686 Munchen
Germania