Last week the U.S. Food and Drug Administration (FDA) approved a drug that is produced using 3-D printing technology.
While the agency has previously approved 3-D printed medical devices, including prosthetics, this marks the first time a drug product manufactured with the technology has been approved by the FDA.
The new drug, Spritam, was developed by Aprecia Pharmaceuticals Co. to control seizures brought on by epilepsy.
Using Aprecia’s ZipDose technology, each 3-D printed tablet delivers up to 1,000 mg of levetiracetam in a single dose which disintegrates in the mouth with a sip of liquid.
“By combining 3-DP technology with a highly-prescribed epilepsy treatment, Spritam is designed to fill a need for patients who struggle with their current medication experience,” explained Aprecia CEO Don Wetherhold. “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.”
The ZipDose technology platform is based on 3-D printing technology originally developed at the Massachusetts Institute of Technology (MIT). Aprecia holds an exclusive, worldwide license for pharmaceutical applications of this technology.
Printing allows layers of medication to be packaged tightly together in precise dosages, and the resulting structure allows the drug to dissolve much faster than the average pill.
3-D printing of drugs will also potentially enable medical institutions to personalize the dose for individual patients simply by adjusting the software before printing.
Spritam is expected to become available in the first quarter of 2016.