Aprecia Pharmaceuticals has announced the FDA approval of the SPRITAM® levetiracetam, a drug to treat epilepsy. The tablets were produced by their proprietary ZipDose® Technology platform. It is the first time a drug produced by 3D printing is accepted by the federal agency.
The 3D ZipDose Technology was conceived to improve the patient´s experience when taking their medication. A single sip of water can carry up to 1,000 mg of drug load, facilitating the treatment of children, elderly and swalowing disorder patients.
Almost 3 million people are diagnosed with epilepsy in the US. Patients that skip doses are much more likely to suffer a myoclonic seizure, and almost half of them report to have experienced a seizure after missing a dose. Aprecia resorted to ZipDose, the 3D printing technology originated at Massachusetts Institute of Technology (M.I.T.). Layers of the powdered drug are 3D printed and bound together in a porous formulation that rapidly disintegrates with water.
Another advantage is the uniform and patient-tailored amount of drug in each tablet. Doctors can prescribe big pills and be certain that the patient took the exactly intended dose.