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WO2009034541A3 - Controlled release pharmaceutical dosage forms of trimetazidine - Google Patents

Controlled release pharmaceutical dosage forms of trimetazidine Download PDF

Info

Publication number
WO2009034541A3
WO2009034541A3 PCT/IB2008/053679 IB2008053679W WO2009034541A3 WO 2009034541 A3 WO2009034541 A3 WO 2009034541A3 IB 2008053679 W IB2008053679 W IB 2008053679W WO 2009034541 A3 WO2009034541 A3 WO 2009034541A3
Authority
WO
WIPO (PCT)
Prior art keywords
trimetazidine
dosage forms
controlled release
pharmaceutical dosage
release pharmaceutical
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2008/053679
Other languages
French (fr)
Other versions
WO2009034541A9 (en
WO2009034541A2 (en
Inventor
Sweta Varshney
Anant Ramesh Katkar
Kalaiselvan Ramaraju
Rajan Kumar Verma
Rajeev Singh Raghuvanshi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories 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 Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Priority to EP08807614A priority Critical patent/EP2200591A2/en
Publication of WO2009034541A2 publication Critical patent/WO2009034541A2/en
Publication of WO2009034541A3 publication Critical patent/WO2009034541A3/en
Publication of WO2009034541A9 publication Critical patent/WO2009034541A9/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to new solid dosage forms for the controlled release of trimetazidine suitable for once-daily dosing, in which the dosage form exhibits a controlled in vitro release of trimetazidine in phosphate buffer at pH 6.8 of not less than about 75% after 16 hours when measured using USP Apparatus I at 100 rpm, thereby decreasing the incidence and severity of burst release or dose dumping.
PCT/IB2008/053679 2007-09-11 2008-09-11 Controlled release pharmaceutical dosage forms of trimetazidine Ceased WO2009034541A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08807614A EP2200591A2 (en) 2007-09-11 2008-09-11 Controlled release pharmaceutical dosage forms of trimetazidine

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN1925/DEL/2007 2007-09-11
IN1925DE2007 2007-09-11
IN1226/DEL/2008 2008-05-16
IN1226DE2008 2008-05-16

Publications (3)

Publication Number Publication Date
WO2009034541A2 WO2009034541A2 (en) 2009-03-19
WO2009034541A3 true WO2009034541A3 (en) 2009-07-30
WO2009034541A9 WO2009034541A9 (en) 2009-12-30

Family

ID=40120263

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/053679 Ceased WO2009034541A2 (en) 2007-09-11 2008-09-11 Controlled release pharmaceutical dosage forms of trimetazidine

Country Status (2)

Country Link
EP (1) EP2200591A2 (en)
WO (1) WO2009034541A2 (en)

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9161917B2 (en) 2008-05-09 2015-10-20 Grünenthal GmbH Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet
US9629807B2 (en) 2003-08-06 2017-04-25 Grünenthal GmbH Abuse-proofed dosage form
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US9750701B2 (en) 2008-01-25 2017-09-05 Grünenthal GmbH Pharmaceutical dosage form
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US9913814B2 (en) 2014-05-12 2018-03-13 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9925146B2 (en) 2009-07-22 2018-03-27 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US10130591B2 (en) 2003-08-06 2018-11-20 Grünenthal GmbH Abuse-proofed dosage form
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US10335373B2 (en) 2012-04-18 2019-07-02 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US11224576B2 (en) 2003-12-24 2022-01-18 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US11844865B2 (en) 2004-07-01 2023-12-19 Grünenthal GmbH Abuse-proofed oral dosage form

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR201001902A2 (en) 2010-03-12 2011-04-21 Ali̇ Rai̇f İlaç Sanayi̇ Ve Ti̇caret A.Ş. Trimetazidine tablets with extended release
PL2394644T3 (en) * 2010-05-04 2014-11-28 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Trimetazidine Formulation With Different Release Profiles
CN102824644B (en) * 2012-09-13 2013-12-25 浙江诚意药业有限公司 High-stability sustained-release tablet prepared by using hydroxy propyl cellulose
AU2016319203A1 (en) 2015-09-10 2018-02-22 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
EP3525771A4 (en) 2016-11-21 2020-05-27 Saghmos Therapeutics, Inc. Prevention and/or treatment of contrast-induced acute kidney injury
US20180190374A1 (en) * 2017-01-03 2018-07-05 Saghmos Therapeutics, Inc. Methods of improving patient compliance to treat contrast-induced injury
CN109908096A (en) * 2017-12-12 2019-06-21 武汉武药科技有限公司 A kind of trimetazidine hydrochloride sustained-release tablets and preparation method thereof
CN110623934B (en) * 2019-09-26 2022-05-13 杭州百诚医药科技股份有限公司 Trimetazidine hydrochloride sustained release tablet and preparation method thereof
CN111888476A (en) * 2020-08-17 2020-11-06 深圳市道科思医药有限公司 Modified release pharmaceutical composition of trimetazidine dihydrochloride

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0625055B2 (en) * 1985-03-18 1994-04-06 日本ケミフア株式会社 Persistent tablets
AU684893B2 (en) * 1994-03-24 1998-01-08 Les Laboratoires Servier Pharmaceutical compositions permitting the prolonged release of trimetazidine after oral administraiton
EP1195160A1 (en) * 2000-10-05 2002-04-10 USV Ltd. Sustained release trimetazidine pharmaceutical compositions and a method of their preparation
WO2002051417A1 (en) * 2000-12-26 2002-07-04 Les Laboratoires Servier Thermofomable solid pharmaceutical composition for controlled release of trimetazidine
AU780011B2 (en) * 1999-12-17 2005-02-24 Les Laboratoires Servier Matrix tablet enabling the prolonged release of trimetazidine after administration by the oral route
WO2006123073A1 (en) * 2005-05-18 2006-11-23 Les Laboratoires Servier Sustained release solid pharmaceutical composition of 1-(2,3,4-trimethoxybenzyl)piperazine and a method for the preparation thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2002356425A1 (en) 2001-11-21 2003-06-10 Themis Laboratories Private Limited A process for manufacture of a sustained release composition containing microbe

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0625055B2 (en) * 1985-03-18 1994-04-06 日本ケミフア株式会社 Persistent tablets
AU684893B2 (en) * 1994-03-24 1998-01-08 Les Laboratoires Servier Pharmaceutical compositions permitting the prolonged release of trimetazidine after oral administraiton
AU780011B2 (en) * 1999-12-17 2005-02-24 Les Laboratoires Servier Matrix tablet enabling the prolonged release of trimetazidine after administration by the oral route
EP1195160A1 (en) * 2000-10-05 2002-04-10 USV Ltd. Sustained release trimetazidine pharmaceutical compositions and a method of their preparation
WO2002051417A1 (en) * 2000-12-26 2002-07-04 Les Laboratoires Servier Thermofomable solid pharmaceutical composition for controlled release of trimetazidine
WO2006123073A1 (en) * 2005-05-18 2006-11-23 Les Laboratoires Servier Sustained release solid pharmaceutical composition of 1-(2,3,4-trimethoxybenzyl)piperazine and a method for the preparation thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 198644, Derwent World Patents Index; AN 1986-289031, XP002529250 *
KRISHNAIAH Y S R ET AL: "Three-layer guar gum matrix tablet formulations for oral controlled delivery of highly soluble trimetazidine dihydrochloride", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 81, no. 1-2, 17 May 2002 (2002-05-17), pages 45 - 56, XP004351102, ISSN: 0168-3659 *

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US10369109B2 (en) 2002-06-17 2019-08-06 Grünenthal GmbH Abuse-proofed dosage form
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US9629807B2 (en) 2003-08-06 2017-04-25 Grünenthal GmbH Abuse-proofed dosage form
US10130591B2 (en) 2003-08-06 2018-11-20 Grünenthal GmbH Abuse-proofed dosage form
US11224576B2 (en) 2003-12-24 2022-01-18 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US11844865B2 (en) 2004-07-01 2023-12-19 Grünenthal GmbH Abuse-proofed oral dosage form
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US10675278B2 (en) 2005-02-04 2020-06-09 Grünenthal GmbH Crush resistant delayed-release dosage forms
US9750701B2 (en) 2008-01-25 2017-09-05 Grünenthal GmbH Pharmaceutical dosage form
US9161917B2 (en) 2008-05-09 2015-10-20 Grünenthal GmbH Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet
US10493033B2 (en) 2009-07-22 2019-12-03 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US9925146B2 (en) 2009-07-22 2018-03-27 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10864164B2 (en) 2011-07-29 2020-12-15 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US10335373B2 (en) 2012-04-18 2019-07-02 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US9913814B2 (en) 2014-05-12 2018-03-13 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction

Also Published As

Publication number Publication date
WO2009034541A9 (en) 2009-12-30
WO2009034541A2 (en) 2009-03-19
EP2200591A2 (en) 2010-06-30

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