“We chose a couple of organisms that were
associated with deep bone infections, and we
were able to demonstrate that the drug
exposed on the surface of a medical device
inhibited micro-organisms and retained its
functionality, despite being treated in our
‘nano-onion skin’ mechanism.
“The experiments were undertaken
the laboratory with captured micro-organisms.
It’s a point of debate about whether you should
deliberately infect an animal in order to realise
a medical breakthrough. In this particular case,
it was not necessary.
“This was very much a demonstration product
to show that the technology worked. What
scientists have to be careful of is making bold
extrapolations from one piece of data. We very
much did this as a proof of concept to show if
it works with this particular drug. It would in
theory work with other drugs, and indeed not
only antimicrobials, but even antigenic
substances for increasing blood capillary
growth, or anabolic substances for increasing
tissue regeneration. Once you have
demonstrated this technology will work, then
in theory it could be applied to a wide range
of other functional, biological molecules.”
Benefit the patient
The length of time it will take to bring such
benefits to patients is “a global problem” and
“a global challenge” says Hatton, one which he
says Europe is very much focused on.
Commercialisation seems to be the next step
for the project, as the academic said he was in
talks with businesses.
“Over the next few months, we would hopefully
resolve which of the technologies from our
project would be the most appropriate to be
adopted by industry, and then we would work
with industrial partners to translate the science
from our lab to their products. It would not be
unreasonable to see this kind of technology
reaching the market in 12-36 months.
“The problems now are not the science, but
rather the upscaling and the regulatory
compliance – you move to a different area of
speciality and it’s important to get the claims
“It would be relatively easy to take materials and a packet of antibiotics
and let it leak out. Yet such a drug delivery device fails to comply with
the complex regulatory environment.
“One of our interests, both in this project and with some national funding,
is to see if we can functionalise the surface of a material, so that the
device retains functionality and the regulator will view it as a device. We
wanted something where the antimicrobial action was bound to the
surface, and that is what we have been experimenting with in this project.
“Our ambition was to demonstrate that a drug could be placed on the
surface of a device in such a way that it would not be unreasonable for
somebody to define this as a device, thus with all of the benefits and
cost effectiveness of regulatory compliance. This is still a debate to be
had, and although I’m not guaranteeing that the regulators will fully agree
with this approach, it’s a very timely debate.”
Hatton then detailed the scientific background to the project and the
“The actual concept is not a new idea – it is called layer by layer
fabrication and what you are essentially doing is introducing alternating
hydrophilic and hydrophobic layers like an onion skin, but on the
nanoscale. Between each layer of the ‘onion skin’, we placed an
antibiotic. You can place any biofunctional molecule there, but we
thought an antibiotic would be good because it kills micro-organisms.
Whilst it would be possible to use many other complex molecules, it
would be harder to prove it was there and working, whereas an antibiotic
is known for its functionality and we knew if the technology worked, we
would be able to demonstrate its effectiveness.
“We used the antibiotic metronidazole, placing it between 20 nanoscale
layers in total. We then judged whether the antibiotic was there, which
it was, and how when it was exposed to the environment, it was lethal
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that infection was
concern for clinicians