Quo vadis Nano?
Nanomaterialien in der pharmazeutischen Produktentwicklung
Übersichten
KEY WORDS EMA | EU-Richtlinien | FDA | Nanomaterialien | Nanotechnologie | Toxikologie
Abstract
Quo vadis Nano? / Nanomaterials for Pharmaceutical Formulation Development
During the past decade nanotechnology has become an essential part of formulation development in the pharmaceutical industry. Liposomes, micelles and nanoparticles have all been utilized to increase the bioavailability of drugs, reduce acute toxicity, and to target compounds to the site of action. Furthermore, a variety of excipients used in cosmetics, food, medical devices, and medicinal products contain particles in the nanoscale. With the new definition from the European Commission from 2011 they have been classified as “nanomaterials”. While the new legislation demands nanospecific risk assessment for these substances, a public controversy has been raised about the safety of nanotechnology in general. The question is how do these regulations affect product development in the pharmaceutical industry and what the future still holds.
· 2 Fraunhofer-Institut für Molekularbiologie und Angewandte Ökologie IME, Abteilung Ökotoxikologie, Schmallenberg
· 3 Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM, Abteilung Inhalation Toxicology & Chemical Risk Assessment, Hannover
Korrespondenz:
Dr. Matthias G. Wacker, Fraunhofer-Institut für Molekularbiologie und Angewandte Ökologie IME, Projektgruppe
