FDA Approves First 3D-Printed Drug Product

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-09-02-2015, Volume 11, Issue 9

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

Aprecia Pharmaceuticals announced on Aug. 3, 2015 that FDA has approved SPRITAM levetiracetam, the first 3D-printed drug product, for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy. 

SPRITAM is manufactured with Aprecia's ZipDose Technology platform, which uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid, the company reports. The approval marks the first time a drug product manufactured with this technology has been approved by the FDA, according to an Aprecia Pharmaceuticals news release.

ZipDose Technology enables the delivery of up to 1000 mg in a single dose, the company reports. Administration of even the largest strengths of levetiracetam with a sip of liquid. The product is expected to be available in the first quarter of 2016.

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ZipDose Technology combines formulation science with the manufacturing capabilities of 3DP. Aprecia developed its ZipDose Technology platform using the 3DP technology that originated at Massachusetts Institute of Technology (MIT).

Source: Aprecia Pharmaceuticals