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
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.