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In early August, FDA approved Aprecia Pharma’s Spritam, an oral solid drug formulation of the epilepsy drug levetiracetam, manufactured using 3D printing technology, and used for the treatment of epilepsy seizures. Aprecia’s proprietary 3D printing process, “ZipDose,” produces pills that are more porous than those made by conventional tableting processes, which dissolve almost instantaneously when added to liquid. Aprecia refers to these new 3D-printed pills as “fast-melt,” to differentiate them from tablets and capsules. FDA approval of the 3D printing process could pave the way for individualized medicine applications.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
