Printed levetiracetam pill approved for use by the FDA

Printed levetiracetam pill approved for use by the FDA

The US Food and Drug Administration (FDA) has given the go-ahead to a 3D printed pill containing the epilepsy drug levetiracetam.

Aprecia Pharmaceuticals’ Spritam, licensed as adjunctive therapy for partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy, is manufactured using a 3D printing technology called ZipDose.

The technique enables the delivery of a high drug load, up to 1,000mg, in a single porous formulation. According to Aprecia Pharmaceuticals, the formulation marks a breakthrough for patients who may have difficulty swallowing their medication because the printed pill rapidly disintegrates when taken with a sip of water.

“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,” says company chief executive officer Don Wetherhold. “This is the first in a line of central nervous system products Aprecia plans to introduce.”

The company expects the product to be available in the United States in spring 2016 and is currently evaluating other possible markets.

A spokesperson for the FDA confirmed that Spritam is the first 3D-printed tablet it has approved.

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Citation
The Pharmaceutical Journal, PJ, 22/29 August 2015, Vol 295, No 7876/7;295(7876/7):DOI:10.1211/PJ.2015.20069122