WO2010026467A3 - Controlled release tablet of a highly water soluble active agent such as levetiracetam, or citicoline - Google Patents

Controlled release tablet of a highly water soluble active agent such as levetiracetam, or citicoline Download PDF

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Publication number
WO2010026467A3
WO2010026467A3 PCT/IB2009/006733 IB2009006733W WO2010026467A3 WO 2010026467 A3 WO2010026467 A3 WO 2010026467A3 IB 2009006733 W IB2009006733 W IB 2009006733W WO 2010026467 A3 WO2010026467 A3 WO 2010026467A3
Authority
WO
WIPO (PCT)
Prior art keywords
citicoline
levetiracetam
water soluble
controlled release
dosage form
Prior art date
Application number
PCT/IB2009/006733
Other languages
French (fr)
Other versions
WO2010026467A2 (en
Inventor
Jaya Abraham
Vinodkumar Gupta
Bhavesh Shah
Original Assignee
Torrent Pharmaceuticals Ltd.
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 Torrent Pharmaceuticals Ltd. filed Critical Torrent Pharmaceuticals Ltd.
Publication of WO2010026467A2 publication Critical patent/WO2010026467A2/en
Publication of WO2010026467A3 publication Critical patent/WO2010026467A3/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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/2022—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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone

Abstract

The present invention relates to a solid oral controlled release dosage form comprising high solubility active ingredient, wherein the dosage form is manufactured by single step granulation using at least one hydrophobic release controlling agent. The said dosage form is further coated using at least one hydrophobic release controlling agent. The present invention further discloses the process for preparing the said dosage form. Preferred water soluble drugs are levetiracetam or citicoline.
PCT/IB2009/006733 2008-09-04 2009-09-03 Controlled release dosage form of high solubility active ingredient WO2010026467A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1868MU2008 2008-09-04
IN1868/MUM/2008 2008-09-04

Publications (2)

Publication Number Publication Date
WO2010026467A2 WO2010026467A2 (en) 2010-03-11
WO2010026467A3 true WO2010026467A3 (en) 2011-06-03

Family

ID=41797589

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/006733 WO2010026467A2 (en) 2008-09-04 2009-09-03 Controlled release dosage form of high solubility active ingredient

Country Status (1)

Country Link
WO (1) WO2010026467A2 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2393483B1 (en) 2009-02-09 2017-06-28 UCB Biopharma SPRL Pharmaceutical compositions comprising brivaracetam
TR200905670A1 (en) * 2009-07-22 2011-02-21 Sanovel �La� San.Ve T�C.A.�. Levetiracetam pharmaceutical compositions for prolonged release
US9333175B2 (en) * 2010-06-16 2016-05-10 Mylan Inc. Controlled release levetiracetam formulations and methods for producing the same
CN102688214B (en) * 2012-06-15 2013-05-22 孙威 Preparation method of levetiracetam sustained release tablet
WO2014025593A1 (en) * 2012-08-08 2014-02-13 PharmTak, Inc. Extended-release levetiracetam and method of preparation
KR101659983B1 (en) * 2012-12-31 2016-09-26 주식회사 삼양바이오팜 Melt-extruded release controlled pharmaceutical composition and oral dosage form comprising the same
CN103191079B (en) * 2013-04-01 2014-03-26 济南利民制药有限责任公司 Citicoline sodium tablet and preparation method thereof
PL3331501T3 (en) 2015-08-08 2020-03-31 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Gastro-resistant formulation containing posaconazole

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185159A (en) * 1983-07-20 1993-02-09 Sanofi Pharmaceutical composition based on valproic acid and a process for preparing it
WO2000028989A1 (en) * 1998-11-12 2000-05-25 Smithkline Beecham P.L.C. Pharmaceutical composition for modified release of an insulin sensitiser and another antidiabetic agent
WO2001022940A1 (en) * 1999-09-30 2001-04-05 Edward Mendell Co., Inc. Sustained release matrix systems for highly soluble drugs
WO2003007918A1 (en) * 2001-07-19 2003-01-30 Phoqus Pharmaceuticals Limited Zero order controlled drug delivery system
WO2003047529A2 (en) * 2001-12-04 2003-06-12 Biovail Laboratories Inc. Extended release pharmaceutical tablet of metformin
WO2006080029A1 (en) * 2005-01-27 2006-08-03 Alembic Limited Extended release formulation of levetiracetam
WO2007000779A2 (en) * 2005-06-29 2007-01-04 Panacea Biotec Ltd. Pharmaceutical sustained release compositions and processes thereof
WO2008062446A2 (en) * 2006-09-14 2008-05-29 Alembic Limited An extended release composition of levetiracetam, which exhibits no adverse food effect
FR2912056A1 (en) * 2007-02-05 2008-08-08 Rd Pharmagal Soc Par Actions S Solid pharmaceutical dosage form useful for treating epilepsy comprises a core comprising levetiracetam, a water-soluble polymer and a lubricant and a coating that is semipermeable to water

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY113429A (en) 1995-02-28 2002-02-28 Univ Temple Controlled release tablet containing swellable polyethylene oxide
ATE302597T1 (en) 1997-06-06 2005-09-15 Depomed Inc STOMACH-RESIDENT ORAL DOSAGE FORMS OF WATER-SOLUBLE DRUGS WITH CONTROLLED RELEASE
US6337091B1 (en) 1997-10-27 2002-01-08 Temple University - Of The Commonwealth System Of Higher Education Matrix for controlled delivery of highly soluble pharmaceutical agents
AP1224A (en) 1998-03-19 2003-11-14 Bristol Myers Squibb Co Biphasic controlled release delivery system for high solubility pharmaceuticals and method.
CA2427195C (en) 2000-11-03 2009-10-06 Andrx Corporation Controlled release metformin compositions
CN1628690A (en) 2003-12-15 2005-06-22 孟繁浩 Citicoline slow controlled release preparation and preparing method thereof
ES2403069T3 (en) 2005-02-22 2013-05-13 Sun Pharma Advanced Research Company Ltd Oral controlled release composition containing levetiracetam
US20080014271A1 (en) 2006-07-13 2008-01-17 Ucb, S.A. Novel pharmaceutical compositions comprising levetiracetam

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5185159A (en) * 1983-07-20 1993-02-09 Sanofi Pharmaceutical composition based on valproic acid and a process for preparing it
WO2000028989A1 (en) * 1998-11-12 2000-05-25 Smithkline Beecham P.L.C. Pharmaceutical composition for modified release of an insulin sensitiser and another antidiabetic agent
WO2001022940A1 (en) * 1999-09-30 2001-04-05 Edward Mendell Co., Inc. Sustained release matrix systems for highly soluble drugs
WO2003007918A1 (en) * 2001-07-19 2003-01-30 Phoqus Pharmaceuticals Limited Zero order controlled drug delivery system
WO2003047529A2 (en) * 2001-12-04 2003-06-12 Biovail Laboratories Inc. Extended release pharmaceutical tablet of metformin
WO2006080029A1 (en) * 2005-01-27 2006-08-03 Alembic Limited Extended release formulation of levetiracetam
WO2007000779A2 (en) * 2005-06-29 2007-01-04 Panacea Biotec Ltd. Pharmaceutical sustained release compositions and processes thereof
WO2008062446A2 (en) * 2006-09-14 2008-05-29 Alembic Limited An extended release composition of levetiracetam, which exhibits no adverse food effect
FR2912056A1 (en) * 2007-02-05 2008-08-08 Rd Pharmagal Soc Par Actions S Solid pharmaceutical dosage form useful for treating epilepsy comprises a core comprising levetiracetam, a water-soluble polymer and a lubricant and a coating that is semipermeable to water

Also Published As

Publication number Publication date
WO2010026467A2 (en) 2010-03-11

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