Epilepsy drug is first FDA-approved 3D printed pill

The first 3D printed pill has been approved for use by the US Food and Drug Administration (FDA).


Developed by Aprecia Pharmaceuticals, Spritam (levetiracetam) is an oral adjunctive therapy to treat a range of seizures in adults and children with epilepsy.

The drug is fabricated with Aprecia’s proprietary ZipDose Technology platform, which uses 3D printing to produce a porous, high-dose formulation that rapidly disintegrates with the intake of a small amount of liquid.

According to Aprecia, potential therapies made via ZipDose are assembled in layers without using compression forces or traditional moulding techniques. Thin layers of powdered medication are repeatedly spread on top of one another, as patterns of liquid droplets are deposited or printed onto selected regions of each powder layer. Interactions between the powder and liquid then bond these materials together at a microscopic level. The resultant drug is highly porous and can support doses of up to 1,000mg that disintegrate in the patient in less than 10 seconds.

“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,” said Don Wetherhold, CEO of Aprecia. “This is the first in a line of central nervous system products Aprecia plans to introduce.”

Spritam is expected to be available in the first quarter of 2016.