Aprecia Pharmaceuticals Launches SPRITAM® (Levetiracetam), the First FDA-Approved 3D-Printed Prescription Drug, for Epilepsy Treatment

On March 23, 2016, Aprecia Pharmaceuticals announced the official market launch of SPRITAM (levetiracetam) orally disintegrating tablets, the first FDA-approved prescription drug product utilizing 3D printing technology.For the treatment of epileptic seizuresLast August, SPRITAM received FDA marketing approval.

I. Rapid dissolution of the drug is achieved,Addressing the Challenge of Difficulty in Swallowing Pills

Aprecia Pharmaceuticals, headquartered in Pennsylvania, is the only pharmaceutical company globally to have developed 3D-printed medications. Powder-liquid 3D printing technology was originally developed by the Massachusetts Institute of Technology (MIT) in the 1980s. This technique uses a water-based liquid binder to fuse multiple layers of powdered material into three-dimensional structures. Aprecia licensed MIT’s 3D printing technology for pharmaceutical applications and subsequently developed its ZipDose technology platform. Instead of employing traditional tablet compression methods, it manufactures medications through layer-by-layer printing. The resulting tablets dissolve rapidly with just a small sip of water in under 10 seconds, offering patients a novel oral administration experience. In a comparative video released by Aprecia Pharmaceuticals, standard over-the-counter (OTC) tablets were shown to take more than 40 seconds to dissolve, whereas SPRITAM completed the process in just 4 seconds.


SPRITAM can now serve as an adjunctive therapy for focal onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. In 2013, nearly three million people in the United States were living with epilepsy. Currently, there are approximately 150,000 new cases diagnosed each year. Because dysphagia often occurs during epileptic seizures, addressing swallowing difficulties has long been a significant challenge for pharmaceutical manufacturers. According to online surveys conducted in the United States, 40% to 50% of respondents, including those without epilepsy, reported difficulty swallowing medications.

Don Wetherhold, CEO of Aprecia, stated, “When we sought to apply 3D technology to the manufacturing of prescription drugs, it was crucial to consider whether the drug’s form truly met patients’ needs. SPRITAM is the first product in our portfolio transforming the way epilepsy medications are administered, and we will provide more treatment options for patients and caregivers.”

II. Breaking Traditional Dose Limits, with a Maximum Dose of 1000 mg

Traditional soluble drug dosage ranges are constrained or significantly limited by modeling techniques, whereas ZipDose technology, based on 3D printing, does not rely on these limitations. ZipDose can achieve drug dosages of up to 1,000 mg while maintaining rapid disintegration. SPRITAM, produced through standardized, commercial manufacturing, is available in four dosage strengths: 250 mg, 500 mg, 750 mg, and 1,000 mg.

III. 3D Printing Leads a New Medical Revolution

Currently, the application of 3D printing technology in the medical field is becoming increasingly common, with significant advances made particularly in the areas of in vitro medical devices, 3D-printed implants, and 3D-printed cells and organs. The 3D printing of prescription medications may be just the beginning. In the future, as technology advances, we will be able to print tablets with dosages tailored to individual physiological conditions, or even create pills in various interesting shapes according to personal preferences, thereby achieving personalized medication.

Hod Lipson, Professor of Mechanical Engineering and Computer Science at Cornell University, proposed the concept of a “3D-Printed Ladder of Life,” which arranges various body parts into a hierarchical ladder. At the base of the ladder are non-living prosthetics; the middle tier comprises simple living tissues such as bone and cartilage; higher up are veins and skin; closest to the top are complex and vital organs, such as the heart, liver, and brain; and at the pinnacle of the ladder lies the complete unit of life—perhaps one day, a fully functional artificial life form.