Abstract

FORMULATION AND OPTIMIZATION OF EXTENDED RELEASE TABLET OF LEVETIRACETAM

Pandey Vagisha* and Birle Rekha

ABSTRACT

Levetiracetam is a second-generation antiepileptic drug (AED) with a unique chemical structure and mechanism of action. The extended release formulation of levetiracetam (Keppra XR™; UCB Pharma) was recently approved by the Food and Drug Administration for adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Levetiracetam has nearly ideal pharmacokinetics. It is rapidly and almost completely absorbed after oral ingestion, is <10% protein-bound, demonstrates linear kinetics, is minimally metabolized through a pathway independent of the cytochrome P450 system, has no significant drug–drug interactions, and has a wide therapeutic index. levetiracetam were formulated by using the superdisintegrants, Mehthylen chloride, isopropyl alcohol and Methocell K100 M and Mg stearate respectively the dosage form was found successful to prepare extended release tablet. Selection of drug, Review Of Literature. Preformulation study, Identification by FTIR method, Analytical methodology of API, Drug –excipient compatibility, Study by FTIR /DSC, Prototype formulation development (Direct compression, Wet granulation), Selection of excipient (Diluent /fillers, Rate controlling polymer, binder, lubricants).QC Test (Hardness, Friability), Stability studies.

Keywords: Extended release tablet, Antiepileptic, Levetiracetam, FTIR, Isopropyl alcohol.