WO2008062446A3 - An extended release composition of levetiracetam, which exhibits no adverse food effect - Google Patents

An extended release composition of levetiracetam, which exhibits no adverse food effect Download PDF

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Publication number
WO2008062446A3
WO2008062446A3 PCT/IN2007/000420 IN2007000420W WO2008062446A3 WO 2008062446 A3 WO2008062446 A3 WO 2008062446A3 IN 2007000420 W IN2007000420 W IN 2007000420W WO 2008062446 A3 WO2008062446 A3 WO 2008062446A3
Authority
WO
WIPO (PCT)
Prior art keywords
levetiracetam
extended release
exhibits
food effect
release composition
Prior art date
Application number
PCT/IN2007/000420
Other languages
French (fr)
Other versions
WO2008062446A2 (en
Inventor
Rajesh Kshirsagar
Ashwin Rao
Nilesh Malaviya
Kaustubh Jinturkar
Original Assignee
Alembic Ltd
Rajesh Kshirsagar
Ashwin Rao
Nilesh Malaviya
Kaustubh Jinturkar
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alembic Ltd, Rajesh Kshirsagar, Ashwin Rao, Nilesh Malaviya, Kaustubh Jinturkar filed Critical Alembic Ltd
Publication of WO2008062446A2 publication Critical patent/WO2008062446A2/en
Publication of WO2008062446A3 publication Critical patent/WO2008062446A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/18—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having one double bond between ring members or between a ring member and a non-ring member
    • C07D207/22—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having one double bond between ring members or between a ring member and a non-ring member with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D207/24—Oxygen or sulfur atoms
    • C07D207/26—2-Pyrrolidones
    • C07D207/263—2-Pyrrolidones with only hydrogen atoms or radicals containing only hydrogen and carbon atoms directly attached to other ring carbon atoms
    • C07D207/27—2-Pyrrolidones with only hydrogen atoms or radicals containing only hydrogen and carbon atoms directly attached to other ring carbon atoms with substituted hydrocarbon radicals directly attached to the ring nitrogen atom

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to extended release pharmaceutical compositions of Levetiracetam, which exhibits no adverse food effect, and processes for preparing the same. The extended release tablet of Levetiracetam is with a 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 patient's blood plasma.
PCT/IN2007/000420 2006-09-14 2007-09-14 An extended release composition of levetiracetam, which exhibits no adverse food effect WO2008062446A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1466/MUM/2006 2006-09-14
IN1466MU2006 2006-09-14

Publications (2)

Publication Number Publication Date
WO2008062446A2 WO2008062446A2 (en) 2008-05-29
WO2008062446A3 true WO2008062446A3 (en) 2008-08-14

Family

ID=39402625

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2007/000420 WO2008062446A2 (en) 2006-09-14 2007-09-14 An extended release composition of levetiracetam, which exhibits no adverse food effect

Country Status (1)

Country Link
WO (1) WO2008062446A2 (en)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2005325930B2 (en) 2005-01-27 2012-01-19 Alembic Limited Extended release formulation of Levetiracetam
WO2010026467A2 (en) 2008-09-04 2010-03-11 Torrent Pharmaceuticals Ltd. Controlled release dosage form of high solubility active ingredient
KR101788804B1 (en) 2008-11-18 2017-10-20 유씨비 파마, 에스.에이. Prolonged release formulations comprising an 2-oxo-1-pyrrolidine derivate
TR200905670A1 (en) 2009-07-22 2011-02-21 Sanovel �La� San.Ve T�C.A.�. Levetiracetam pharmaceutical compositions for prolonged release
EP2298290A1 (en) 2009-09-16 2011-03-23 LEK Pharmaceuticals d.d. Controlled release composition comprising levetiracetam
EP2563339A1 (en) * 2010-04-29 2013-03-06 Lupin Limited Controlled release pharmaceutical compositions of brivaracetam
CA2826765C (en) * 2011-02-09 2021-04-06 The Johns Hopkins University Methods and compositions for improving cognitive function
CA2875784C (en) * 2012-07-16 2020-03-10 Laccure Ab Pharmaceutical compositions containing oligomeric lactic acid
AU2013299938A1 (en) * 2012-08-08 2015-01-22 PharmTak, Inc. Extended-release levetiracetam and method of preparation
US20140206667A1 (en) 2012-11-14 2014-07-24 Michela Gallagher Methods and compositions for treating schizophrenia
ES2881081T3 (en) 2013-03-15 2021-11-26 Agenebio Inc Procedures and compositions to improve cognitive function
US10806717B2 (en) 2013-03-15 2020-10-20 The Johns Hopkins University Methods and compositions for improving cognitive function
MX2017014774A (en) 2015-05-22 2018-02-15 Agenebio Inc Extended release pharmaceutical compositions of levetiracetam.
DK3297611T3 (en) * 2015-05-22 2019-09-02 Agenebio Inc PHARMACEUTICAL COMPOSITIONS OF LEVETIRACETAM WITH LONG-TERM RELEASE
CA2937365C (en) 2016-03-29 2018-09-18 F. Hoffmann-La Roche Ag Granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone and method of making the same

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003101428A1 (en) * 2002-05-31 2003-12-11 Desitin Arzneimittel Gmbh Pharmaceutical composition having a delayed active substance release, and method for the preparation thereof
WO2004010998A1 (en) * 2002-07-25 2004-02-05 Pharmacia Corporation Sustained-release tablet comprising reboxetine
WO2004087175A1 (en) * 2003-04-04 2004-10-14 Pharmacia Corporation Oral extended release compressed tablets of multiparticulates
WO2006015943A2 (en) * 2004-08-13 2006-02-16 Boehringer Ingelheim International Gmbh Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
US20060165796A1 (en) * 2005-01-27 2006-07-27 Alembic Limited Extended release formulation of levetiracetam
WO2006123357A2 (en) * 2005-02-22 2006-11-23 Sun Pharmaceutical Industries Limited Oral controlled release composition containing levetiracetam
WO2008006528A2 (en) * 2006-07-13 2008-01-17 Ucb Pharma, S.A. Pharmaceutical compositions comprising levetiracetam

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003101428A1 (en) * 2002-05-31 2003-12-11 Desitin Arzneimittel Gmbh Pharmaceutical composition having a delayed active substance release, and method for the preparation thereof
WO2004010998A1 (en) * 2002-07-25 2004-02-05 Pharmacia Corporation Sustained-release tablet comprising reboxetine
WO2004087175A1 (en) * 2003-04-04 2004-10-14 Pharmacia Corporation Oral extended release compressed tablets of multiparticulates
WO2006015943A2 (en) * 2004-08-13 2006-02-16 Boehringer Ingelheim International Gmbh Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
US20060165796A1 (en) * 2005-01-27 2006-07-27 Alembic Limited Extended release formulation of levetiracetam
WO2006123357A2 (en) * 2005-02-22 2006-11-23 Sun Pharmaceutical Industries Limited Oral controlled release composition containing levetiracetam
WO2008006528A2 (en) * 2006-07-13 2008-01-17 Ucb Pharma, S.A. Pharmaceutical compositions comprising levetiracetam

Also Published As

Publication number Publication date
WO2008062446A2 (en) 2008-05-29

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