Last month, the Food and Drug Administration approved the manufacture of the world’s first 3D printed pill Spritam, a reformulation of the anti-epileptic seizure drug levetiracetam. In the late 1980s, Michael Cima, professor of Materials Science and Engineering, along with fellow MIT professor Emanuel Sachs invented the 3D printing technology used in the process.
We caught up with Michael Cima to find out what the FDA approval for the manufacturing of a 3D pill means for the future of the pharmaceutical industry.
How did the idea of 3D printing a drug evolve?
Once we developed the 3D printing technology in the 1980s, we licensed it out to eight to 10 different fields. Aprecia Pharmaceuticals bought rights and focused on printing jaw augmentation prosthetics with calcium phosphate. In those with gum disease, the bone might’ve worn down to a point where it was difficult to put in implants. Now, the folks at the company have move on to 3D printing tablets.
Why was the medicine for epilepsy, the first candidate for 3D printed medicine?
Imagine getting a person who is in the middle of a seizure to take a big tablet. The person would find it hard to swallow anything during an episode. It will be great to have something that goes down easily with just a sip of water. Of course, epileptic medicine can also be given as a suppository, but not all caregivers are comfortable with this mode of delivery in public.
With the conventional process you can make porous, rapid-dissolve tablets, but the technique also limits the amount of solution you pour into each grid. That limits the dosage of the pill.
If you use 3D printing to make the same medication, you are printing in layers and that allows you to go as high as five times the conventional dosage in a given volume. So a rapidly dissolving tablet that can deliver a high dose of epilepsy medication fulfills an unmet medical need.
Rapid dissolve tablets are useful in other instances too, one would imagine.
The elderly and children have trouble swallowing pills, in some cases, as do those with Parkinson’s disease. Any medication given to these patients may take the form of rapid dissolve tablets, which go down easily with just one sip of water.
In what other instances would 3D printed pills be useful?
Tablet pressing is an established industry – there is no need to switch to 3D printing for every pill. Only medical need will drive other uses of this technique. For instance, the best thing about this technique is how uniform the dosage will be throughout the pill. Yet the same technique allows for precise non-uniform layers as well, which enables very specific, controlled releases of the drug inside the body.
Then, there is the capability of delivering micro doses of the drug. At small dosage levels, it is not possible to ensure content uniformity with conventional techniques. So certain potent drugs, like the ones in say hormone replacement therapy are now given as injections. It might be possible to deliver them to patients in an oral form.
Now, we can put that one droplet of an ingredient into each individual tablet. Industry has not seen this level of precision before.
Can pharmacies start printing tablets now? Where do you see this technology going next?
Initially, we thought at best these 3D machines would be used in prototyping or manufacturing small lots. Now the pharmaceutical companies have taken this technique to mass manufacture tablets.
And what comes next, I really don’t know though I imagine that many other companies will start 3D printing pills now it has been proved it can be done.
As an inventor, I have realized that the user will discover new uses for a technology I did not dream of. I have fun watching what users make of the invention.
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