For professionals in electronics and materials manufacturing Atomic Layer Deposition technology (ALD) has long been highly valued. ALD is a precise, conformal and customizable nanoscale film coating used to protect and extend the life of many of the world’s most advanced industrial electronics and semiconductor products.
So what if the technology could be used to coat the Active Pharmaceutical Ingredients (APIs) in drugs? A customized film coating of slow-dissolving inorganic oxides encasing the organic API would enable the controlled dissolution of the API into the bloodstream, over days, weeks or months – protecting and stabilizing the API, and extending treatment and effect. This was the intriguing proposal raised by Anders Johansson and Mårten Rooth, Nanexa’s. co-founders, at a meeting with a big pharma company in 2013.
BUT WOULD IT WORK?
“We’d been working on ALD in medical devices when the idea of applying it to APIs first came up. The clients explained their challenges with drug delivery, and we began thinking ‘what if we could use an ALD coating for actual medicine, as well as medical equipment’.
“We’d had mixed results in our medical device projects – but early on with the pharma development we realized ‘we’ve really got something here, this could work. It will be hard, but we can do it’ – and eventually we did.”
The patent for the first ALD-encased API was filed in 2013. Today the first clinical study using a PharmaShell®, ALD-encased pharmaceutical is underway, with others in the pipeline.
‘FIRST IN THE FIELD’
What were the biggest challenges? “Agglomeration. We worked with a lot of substances and kept hitting the wall. Being first in the field though meant that we weren’t fazed, we solved each problem as it arose, we knew this was new territory.
“In the end solving agglomeration was at the heart of our patent and our process. It’s what makes PharmaShell® unique. We build up the shell in repeated layers, coating then sieving until each particle is sealed tight. It’s an ambient process, no solvents, and allows for high drug loads, (up to 80%). It gives exceptional control of the thickness of the coating, enabling great versatility, and making it possible to coastwise a wide range of APIs including biologics, proteins and peptides.”
LONG-ACTING INJECTABLES INTO THE FUTURE
Long-Acting Injectables have big implications, potentially increasing the tolerability of drugs, reducing the number of injections needed in existing long-term treatment regimens and enabling the development of novel therapies. What of the future of ALD and PharmaShell® as a pharmaceutical formulation method?
“I think it will grow. Today, with injectable APIs, you administer the shot, there is an immediate effect – but then the API vanishes quickly into the bloodstream. Being able to prevent that from happening, creating a depot with a tight controllable coating, opens up a lot of possibilities in terms of extending a treatment’s price, effect and value.”