3D Printing Ushers in New Era for the Pharmaceutical Industry. Three-dimensional (3D)-printing technology is on track to change the way we make things and drug manufacturing is no exception. After more than two decades of research on the application of 3D printers in drug manufacturing, the FDA has approved for the very first time a drug formulation produced using 3D-printing technology. The approved drug, Spritam (levetiracetam), is a prescription medicine used as an adjunctive therapy in the treatment of seizures in adults and children with epilepsy.
Spritam is based on the ZipDose® platform technology, which uses 3D-printing technology to manufacture a porous formulation that rapidly disintegrates with a sip of liquid. The ZipDose platform is based on a powder-liquid 3D-printing technology that enables the delivery of a high drug load in a single dose (up to 1,000 mg) and each dose is individually packaged so there is no need to count pills or measure liquids. This technology was originated at the Massachusetts Institute of Technology (MIT) and is expected to revolutionize patient experience and dramatically improve treatment compliance.
Pharmaceutical rights to MIT’s 3D-printing, patent-protected process are exclusively licensed to Arpecia Pharmaceuticals. Arpecia filed the NDA for Spritam, its first product using advanced ZipDose technology, in December 2014. Spritam is expected to be available in the first quarter of 2016.Read more