Extended release formulation of levetiracetam

Details Extended release formulation of levetiracetam Extended release formulation of levetiracetam

2005-08-31

2010-12-28

Krass, Frederick (Department: 1612)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C514S423000

Reexamination Certificate

active

07858122

ABSTRACT:
An extended release pharmaceutical composition of Levetiracetam 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 from about eight to about Sixteen hours. The core is prepared 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.

REFERENCES:
patent: 4389393 (1983-06-01), Schor et al.
patent: 4543370 (1985-09-01), Porter et al.
patent: 4803080 (1989-02-01), Benedikt et al.
patent: 4837223 (1989-06-01), Gobert et al.
patent: 4943639 (1990-07-01), Gobert et al.
patent: 5314697 (1994-05-01), Kwan et al.
patent: 5378474 (1995-01-01), Morella et al.
patent: 5605889 (1997-02-01), Curatolo et al.
patent: 6107492 (2000-08-01), Futagawa et al.
patent: 6274171 (2001-08-01), Sherman et al.
patent: 2004/0062805 (2004-04-01), Vandecruys et al.
patent: 2004/0185097 (2004-09-01), Kannan et al.
patent: 2004/0259933 (2004-12-01), Dolitzky et al.
patent: 2005/0202088 (2005-09-01), Hanshermann et al.
patent: 2006/0008527 (2006-01-01), Lagoviyer et al.
patent: 2006/0269605 (2006-11-01), Lizio et al.
patent: 2007/0105912 (2007-05-01), Holm et al.
patent: 2007/0196481 (2007-08-01), Amidon et al.
patent: WO 01/151033 (2001-07-01), None
patent: WO 03/039519 (2003-05-01), None
patent: WO 03/101428 (2003-12-01), None
patent: WO 2004/105682 (2004-12-01), None
Aulton, Design of peroral modified-release drug delivery systems, Pharmaceuticals, the science of dosage form design, 2nded, p. 295.
Collins et al., Extended release formulations of anticonvulsant medications, CNS Drugs, 2000, vol. 14, No. 3, p. 203-212.
De Smedt et al., Levetiracetam: Part II, the clinical profile of a novel anticonvulsant drug, CNS Drug Reviews, 2007, vol. 13, No. 1, p. 57-78.
Edwards et al., Levetiracetam levels in human cerebrospinal fluid, AAAN Enterprises, Inc., 2004, vol. 62 (7), supplement S5, p. A118.
Epstein et al., Prolonged neurophysiologic effects of levetiracetam after oral administration in humans, Epilepsia, 2008, 49 (7), p. 1169-1173.
Harden, Safety profile of levetiracetam, Epilepsia, 2001, 42 (suppl.4), p. 36-39.
Patsalos, Clinical Pharmacokinetics of levetiracetam, Clin.Pharm, 2004, 43(11), p. 707-724.
Patsalos et al.,In Situmetabolism of levetiracetam in blook of patients with epilepsy, Epilepsia, 2006, 47(11), p. 1818-1821.
Radtke, Pharmacokinetics of levetiracetam, Epilepsia, 2001, 42 (suppl. 4), p. 24-27.
Dow Product Brochure, Sep. 2006.
Keppra Prescribing Information, 2008.
Tong et al., A microdialysis study of the novel antiepileptic drug levetiracetam: extracellular pharmacokinetics and effect on taurine in rat brain, British Journal of Pharmacology, 2001, 133, p. 867-874.

Affiliated with

Also associated with

Rating

Extended release formulation of levetiracetam does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Extended release formulation of levetiracetam, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Extended release formulation of levetiracetam will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-4165547