3D printed drug receives FDA seal of approval

The FDA has approved the first 3D printed drug, Aprecia Pharmaceuticals' Spritam.

The new drug will be used to treat epileptic seizures, and its Massachusetts Institute of Technology (MIT)-created delivery platform allows for oral administration in the form of a small tablet that dissolves quickly in liquid.

Pennsylvania-based Aprecia gained the exclusive license to 3D printing technology from MIT in the late 1980s, and by 2007, it began developing its ZipDose platform for drug delivery, an orodispersible structure that allows for easy-to-swallow tablets. 

Spritam is a new formulation of the commonly prescribed levetiracetam. Its rapid disintegration means it can deliver a high drug load of up to 1,000 mg in a single dose whilst being ideal for patients who have trouble swallowing. The product is expected to be available early next year.

The 3D printing method is a crucial aspect of the product's manufacture; the small tablets are built layer upon layer from the powdered drug, resulting in a structure that ensures the high degree of dissolvability in liquid. Also, because it is made entirely from a powder, each pill has a uniform and therefore precise dose, especially important in a drug intended for the central nervous system.

Aprecia chief executive officer Don Wetherhold said: "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."