EXTENDED RELEASE FORMULATION OF LEVERTIRACETAM

Application 81/MUM/2005 published 2006-08-11, filed 2005-01-27
An extended release pharmaceutical composition of levertiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in form about eight to about Sixteen hours. The core is prepares by Wet granulation, Dry granulation or Direct compression and optionally the tablet core is coated either in an coating pan or in and Fluidized bed system. Drawing: 02 Sheets. Total Pages: 28. Fig. Nil

Applicant

ALEMBIC LIMITED
ALEMBIC CAMPUS, ALEMBIC ROAD, VADODARA-390 003, GUJARAT, INDIA.

Inventor

1. KSHIRSAGAR RAJESH 2. JOSHI MAYANK 3. RAICHANDANI YOGESH

International Info

Classification: A61K 31/4015, A61K 9/22, A61K 9/28, A61K 9/30, A61K 47/38, A61K 47/32, A61P 25/08