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Spritam: World’s First 3D-Printed Drug Product Approved by FDA

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The Food and Drug Administration has approved Spritam, the world’s first 3D-printed prescription drug.

The agency has previously approved medical devices – including prosthetics – that have been 3D printed.

Spritam was developed by Aprecia Pharmaceuticals to control seizures brought on by epilepsy.

Aprecia said that it planned to develop other medications using its 3D platform.

Printing the drugs allows layers of medication to be packaged more tightly in precise dosages.

A separate technology developed by the pharmaceutical company, known as ZipDose, makes high-dose medications easier to swallow.

Printing the drug meant it could package up to 1,000 milligrams into individual tablets.

The 3D-printed pill dissolves in the same manner as other oral medicines.

Photo Aprecia Pharmaceuticals

Photo Aprecia Pharmaceuticals

Being able to 3D print a tablet offers the potential to create bespoke drugs based on the specific needs of patients, rather than having a one product fits all approach, according to experts.

Medical institutions could adjust the dose for individual patients with just a simple tweak to the software before printing. Previously, such personalized medicine would have been extremely expensive to produce.

3D printing works by creating an object layer by layer. In the case of medicines, printers are adapted to produce pharmaceutical compounds rather than polymers which are more usually used.


Such methods are already proving very useful in healthcare with doctors using the system to create customized implants for patients with injuries or other conditions.

Dentists use 3D printers to create replica jaws and teeth as well as other dental implants.

Spritam will launch in Q1 2016, according to Aprecia.