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FDA Approves First 3D-Printed Drug Product
PTSM: Pharmaceutical Technology Sourcing and Management
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.
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