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FDA Approves First 3D-Printed Drug

1532 FDA Approves First 3D-Printed Drug
3D printing drugs could create bespoke medicine. r.classen/Shutterstock

The U.S. Food and Drug Administration (FDA) has for the first time approved the use of a 3D-printed pill. The drug in question – called Spritam – is used to treat certain seizures in those suffering from epilepsy, and the first batch of pills are hoped to hit the shelf by early next year.

“By combining 3DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” said Don Wetherhold, who is the CEO of Aprecia, the pharmaceutical company behind the drug. “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.”


There are actually a number of advantages to 3D printing drugs. Firstly, by controlling how porous the drug is, the manufacturers can control how quickly the pill dissolves, meaning they can make sure the whole thing rapidly breaks down with just a single sip of water. And by layering the medication, they can pack in more of the active ingredient into a smaller pill, delivering up to 1,000 milligrams in a single, easily taken dose.

It is also another step towards personalized medicine. By opening drugs up to the potential of being 3D printed, it means that doctors could tailor drugs to patients. This would essentially create bespoke medication rather than relying on mass-produced pills that might not quite work as intended, where doctors could change the dosage simply by altering the software. It would also mean that the drugs could be produced much closer to where they’re needed, rather than in some factory on the other side of the world.        

“For the last 50 years we have manufactured tablets in factories and shipped them to hospitals and for the first time this process means we can produce tablets much closer to the patient,” Dr. Mohamed Albed Alhnan, who lecturers on pharmaceutics at the University of Central Lancashire, told BBC News.

This is the first time the FDA has approved a 3D-printed medical product to be consumed – although they've already given the go-ahead to other 3D-printed medical devices, with prosthetics and surgical tools already in use. This ruling is interesting, however, as it could pave the way for the approval of other more invasive procedures, like transplanting 3D-printed organs or bone.   


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