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R_www.in-pharmatechnologist.com 2015 00418.txt.txt

#FDA approves first 3d printed drug Aprecia Pharmaceuticals owns Spritam (levetiracetam), a solid oral pill to treat epileptic seizures. The drug is manufactured using a three-dimensional printer which creates a porous formulation that helps bioavailability and patient uptake, the company says. The 3d printer lets the company create a pill with a high drug load up to 1, 000mg of levetiracetam, in a single dose. This allows patients to take the largest strengths of the drug ith just a sip of liquid, helping children, the elderly and people with swallowing disorders to stick to their regimen, said the company. It added, ith Spritam there is no measuring required as each dose is packaged individually, making it easy to carry this treatment on the go-go. It is likely to hit the market in Q1 2016. Levetiracetam is prescribed already widely for epilepsy. Aprecia said the new delivery formulation is designed to help patients who struggle with current dosage forms, and it will soon be applied to other drugs. his 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, said CEO Don Wetherhold. The oral drug delivery market was worth over $64bn last year, according to Frost & Sullivan. MIT invention3d printing has previously been used to make medical devices and replicate organs for preclinical studies, but this is the first FDA approval of a drug product. Aprecia formulation platform, which it calls Zipdose technology, is licensed based on 3d printing from the original inventors at MIT. The patent-protected technique uses liquid to stitch together several layers of powder. Aprecia plans to use its own equipment to manufacture Spritam and other high-dose medicines that rapidly disintegrate with a small amount of liquid, and says it has exclusive rights to pharmaceutical applications of the technology. Prasco Laboratories and its parent company, Scion Companies, have a controlling interest in Aprecia r

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