CATEGORY PRODUCT PROFILE
PRODUCT NAME Levetiracetam SR (Sustained Release) Tablet
(Original : Keppra XR Tablet from UCB)
COMPANY Biopharmartis
DEVELOPMENT
STATUS
Finished fomulation study, BE simulation
(Strengths : 500mg, 750mg)
THERAPEUTIC AREA Antiepileptics
ACTION Binds to a synaptic vesicle protein, SV2A
STRENGTH
  • Diffusion Matrix type SR formulation with identical multi-strength release profile
  • Tablet formulation patent with non-infringement of original fomulation patent
    (KR 2010-0116988, PCT will be available in Oct, 2011)
  • Identical mechanism in simulatied gastric fluid compared with original product
    (Consider BE test in fed mode)
  • Simplified manufacturing process = Low manufacturing cost
TECHNOLOGY SR Platform