A recently-launched project by the European Union is aiming to demonstrate once and for all whether nanoparticles - which underpin the emerging discipline of nanotechnology - are safe, reports Phil Taylor.
New drug delivery systems based on nanoparticles are said to be on the cusp of delivering significant improvements in drug therapy, reducing the amount of active drug that needs to be delivered to the patient, targetting the medicine more effectively to the site in the body it is needed, and reducing side effects, as well as potentially reducing the cost of therapy.
But despite the promise, there are real concerns that exposing patients to nanoparticles might unleash unexpected toxicities, a fear backed up to some extent by the recent discovery that nanoparticles exposure in animals can lead to neurological damage.
To explore this risk further, the European Commission has set up a research project with partners across industry and academia aimed at developing methods for the safe use of nanoparticles.
Starting this month, 23 partners from seven EU countries started work on Nanosafe2, a project with a budget of approximately €12.4 million. Around €7 million is being provided by the EU's research funding programme and the remainder by the companies involved.
One of the commercial partners in the project, German chemical company BASF, is contributing a team of toxicologists that will explore the safety of nanoparticles, which already look set to change the way drugs can be delivered. In just one example, formulation of drug in nanoparticles can allow larger compounds such as peptides - that could previously only be delivered by injection - to be taken via an inhaler.
But inhalation of nanoparticles is just one route of administration being explored. Nanotechnology is also making itself felt in improved formulations of injectable drugs, new implantable drug reservoirs for long-term therapy, increasing the bioavailability of oral drugs, and making transdermal delivery more efficient.
"BASF's involvement in the Nanosafe2 project is a good example of our proactive stance in the area of risk avoidance," said Dr Marcos Gomez from the University Relations and Research Planning department, who coordinates BASF's involvement in EU projects.
The key goal of the Nanosafe2 research programme is to establish processes to detect, track and characterise nanoparticles. Such methods are a prerequisite for determining any possible risks to man or the environment, and for further optimising the safety of production processes and plants.
Nanosafe2 will look at the entire lifecycle of nanoparticles, from their production and storage through to transport and use in a finished product. The results of the research will subsequently be made available worldwide in the form of databases, official procedures and workshops.
"As part of the EU project, we will be carrying out studies to increase our understanding of the possible health risks associated with the inhalation of nanoparticles," explained Dr Edgar Leibold from BASF's Toxicology department. Currently, there are not enough scientific data on how certain nanoparticles behave inside the body, so Nanosafe2 will play an important role in this regard.
Because the emphasis of the project lies on workplace and plant safety, BASF is also involved in developing physical measurement methods and measuring equipment to reliably detect nanoparticles.
"The goal of Nanosafe2 is to ensure the safe use of nanoparticulate materials," said Leibold.