I heard some very intriguing news this past week about the FDA's approval on August 3rd of the world's first 3D printed drug - yes, you heard right - a 3D printed drug! Now, 3D printing (3DP) has been around for a while, mainly in the manufacturing industry as a rapid-fire way of cranking out prototypes to test, but it has also been applied to healthcare issues requiring prosthetics and tissue engineering, for example. While we tend to think of 3DP on a macro scale, nanotechnology and nanomedicine is very much in vogue in 2015, and 3DP is being applied to problems both big and small.
The process of powder-liquid 3DP was developed at MIT decades ago, mainly for prototyping purposes, and the technique uses an aqueous liquid to essentially stitch together multilayers of powder using an innovative and patent-protected procedure which is at the heart of the new technology successfully advanced by specialty pharmaceutical company, Aprecia. The drug just approved by the FDA is called Spritam (levetiracetam) and is designed to facilitate dosing in patients with seizures or epilepsy, who are often not compliant due to the size of their pills and/or other technical reasons.
The beauty of Aprecia's ZipDose® Technology and platform is that it not only facilitates the packing in of as much as 1000mg (a full gram!) of medication into each tablet, but also that this high dose medication disintegrates in water like a bone-dry sandcastle in a rainstorm, as demonstrated in the video above. As if that weren't enough of an advance, Aprecia is also working on the enhanced taste-masking possibilities of ZipDose®, which will resolve yet another reason for non-compliance.
What exactly is ZipDose® Technology? Aprecia inform us that it is "a proprietary, computer-aided, 3DP manufacturing process, which is designed to enable delivery of high-dose medications in a rapidly disintegrating form." ZipDose® Technology product candidates are assembled layer-by-layer without utilising compression forces or traditional moulding techniques. Thin layers of powdered medication are repeatedly spread on top of one another, as patterns of aqueous liquid droplets are deposited or printed onto selected regions of each powder layer. Interactions between the powder and liquid bond these materials together at a microscopic level. The great advantage of this platform is that it yields highly porous structures even at high loading and doses of drug.
Aprecia's tagline is that they are "Harnessing the power of an innovative technologyy" and I think it's kind of hard to argue with that! I actually cannot help wondering how many people who worked on various failed drug candidates are staring at their screens in some mixture of frustration, disbelief and maybe even awe, because if they had had this technology then their major problem would have been resolvable. We often hear about drug candidates failing due to lack of efficacy or toxicity, but formulation is a key part in the pharmaceutical process and once a company realises that their tablet has to be the size of a horse pill, ,well, drug candidates get sidelined.
In my own travels I can think of two cases where dosing and pill size were major issues, one in the field of dyslipidemia and the other in idiopathic pulmonary fibrosis (IPF). As much as people were invested in their leading pipeline candidates, they were simply impossible to formulate in a way that the marketing division would accept and because ulltimately those compounds did not meet the target product profile, they were axed. It's a tough business in those situations, and I bet those folks wish they had been given access to ZipDose® back then!
While the MIT-developed process has many applications in industry in general (and is licensed for those applications), Aprecia was very smart in obtaining an exclusive license to utilise MIT's 3DP technology for pharmaceuticals. This is a move that may well pay off in the very near future, not only via Spritam, but presumably via sub-licenses with various pharma who wish to deliver their drug(s) using ZipDose® Technology. But Aprecia CEO Don Wetherhold is clearly very focused in-house for now, and he elaborated recently on where he is going in the near-term.
“By combining 3D printing technology with a highly prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience. This is the first in a line of central nervous system products Aprecia plans to introduce as part of our commitment to transform the way patients experience taking medication.”
This privately owned company seems to have its head well screwed on and is heading in the right direction, for sure. The FDA approval this week puts Aprecia on a very nice platform of its very own, given that they are world leaders at this stage of the game. They have rights to more than 50 patents pertaining to pharmaceutical applications using 3DP and have filings in place that protect their proprietary manufacturing process through to 2033. With various patents pending and additional filings in the works, it is clear tthat hey intend to keep the wolves at bay and reap the full rewards of this game-changing technology - kudos to them!
In my case I better get out to the terrace and protect my own territory (plants and flowers) from predator (squirrels) invasion; it's turning into a lovely sunny day and so off I go with a mugful of my newest roast - it's the Modena Miscela Mattina Magica (Modena Magical Morning) blend, which seems just about right for this lovely morning. Happy Saturday!
PS - Hot on the heels of the Aprecia approval, and just after publishng of this blog, I heard that the FDA approved the world's first 3D printed spinal implant - so 3DP sure is making big news these days!
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