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FDA Approval Hails Arrival of the 3-D Printed Drug

Article

August 24, 2015.

With the FDA approval earlier this month of Aprecia's Spritam levetiracetam (for reducing epileptic seizures), the pharma industry has entered the 3-D printing age.     Instead of being produced by a tableting machine, The Guardian reports that Aprecia's drug is produced with the company's “ZipDose” technology, which uses 3D printing to create a more porous pill. And its "structure means the pill dissolves more quickly on contact with liquid, making it much easier to swallow high doses than a conventional tablet."   Aprecia is the first major pharmaceutical company to print drugs; The Atlantic noted that Aprecia's website boasts that the company now holds more than 50 patents protecting its own 3-D printing technique and 3-D-printed pharmaceuticals in general, helping it maintain a competitive advantage until 2033.   The Guardian goes on to report that rearchers at the School of Pharmacy of University College London have also been developing a technique to 3D-print pills in different shapes, from pyramids to doughnuts, using hot melt extrusion, while Professor Lee Cronin at Glasgow University (UK) is working on a “chemputer”, described as "a sort of 3D-printing chemistry set, which can be programmed to make chemical reactions and produce different molecules."   The large manufacturers won't be put put of business just yet, however, University of Winsconsin Professor Gregory Higby told The Atlantic. “Some entity still has to produce the drug-the active ingredient in the printer-and that will continue to be controlled by large manufacturers. Only they can afford the costs of getting a new drug approved by the FDA."  

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