Projektbeschreibung
Verabreichung von Arzneimittel für das Zentralnervensystem über die Nasenhöhle
Die Behandlung von Erkrankungen des Zentralnervensystems (ZNS) wie Multiple Sklerose stellt nach wie vor eine große medizinische Herausforderung dar, da die meisten Arzneimittel, einschließlich Antikörper, die Blut-Hirn-Schranke (BHS) nicht wirksam überwinden können. Die Verabreichung von Arzneimitteln über die Nase erreicht das Zentralnervensystem unter Umgehung der Blut-Hirn-Schranke und stellt eine vielversprechende und nicht-invasive Strategie zur Behandlung von ZNS-Erkrankungen dar. Ziel des EU-finanzierten Projekts N2B-patch ist es, ein innovatives Medizinprodukt zu entwickeln, das die Verabreichung von Arzneimitteln über die Nasenhöhle gestattet. Das Produkt wird aus biologisch abbaubaren Polymerpartikeln bestehen, die in eine Hydrogelmatrix eingebettet sind. Die wirkstoffbeladene Formulierung wird eine pH-sensitive Beschichtung aufweisen, die eine spezifische Haftung am Riechepithel gewährleistet und die Bioverfügbarkeit des Arzneimittels im Zentralnervensystem erhöht.
Ziel
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.
Wissenschaftliches Gebiet
- 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
Schlüsselbegriffe
Programm/Programme
Thema/Themen
Aufforderung zur Vorschlagseinreichung
Andere Projekte für diesen Aufruf anzeigenUnterauftrag
H2020-NMBP-2016-two-stage
Finanzierungsplan
RIA - Research and Innovation actionKoordinator
80686 Munchen
Deutschland