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EP1335707A4 - Novel formulations of carvedilol - Google Patents

Novel formulations of carvedilol

Info

Publication number
EP1335707A4
EP1335707A4 EP01273804A EP01273804A EP1335707A4 EP 1335707 A4 EP1335707 A4 EP 1335707A4 EP 01273804 A EP01273804 A EP 01273804A EP 01273804 A EP01273804 A EP 01273804A EP 1335707 A4 EP1335707 A4 EP 1335707A4
Authority
EP
European Patent Office
Prior art keywords
carvedilol
novel formulations
formulations
novel
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.)
Withdrawn
Application number
EP01273804A
Other languages
German (de)
French (fr)
Other versions
EP1335707A2 (en
Inventor
Vlassios Andronis
Kimberly A Lamey
Choon K Oh
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.)
SmithKline Beecham Corp
Original Assignee
SmithKline Beecham Corp
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 SmithKline Beecham Corp filed Critical SmithKline Beecham Corp
Publication of EP1335707A2 publication Critical patent/EP1335707A2/en
Publication of EP1335707A4 publication Critical patent/EP1335707A4/en
Withdrawn legal-status Critical Current

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/403—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 condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K9/2004—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • 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
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP01273804A 2000-10-24 2001-10-23 Novel formulations of carvedilol Withdrawn EP1335707A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24291100P 2000-10-24 2000-10-24
US242911P 2000-10-24
PCT/US2001/050872 WO2002065834A2 (en) 2000-10-24 2001-10-23 Novel formulations of carvedilol

Publications (2)

Publication Number Publication Date
EP1335707A2 EP1335707A2 (en) 2003-08-20
EP1335707A4 true EP1335707A4 (en) 2005-07-06

Family

ID=22916614

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01273804A Withdrawn EP1335707A4 (en) 2000-10-24 2001-10-23 Novel formulations of carvedilol

Country Status (5)

Country Link
EP (1) EP1335707A4 (en)
JP (1) JP2004518734A (en)
AU (1) AU2001297631A1 (en)
CA (1) CA2426811A1 (en)
WO (1) WO2002065834A2 (en)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2327685C (en) 1998-04-03 2008-11-18 Bm Research A/S Controlled release composition
IN191028B (en) * 2001-05-17 2003-09-13 Sun Pharmaceutical Ind Ltd
ATE381924T1 (en) * 2001-09-21 2008-01-15 Egalet As SOLID DISPERSIONS WITH CONTROLLED RELEASE OF CARVEDILOL
WO2003024430A1 (en) 2001-09-21 2003-03-27 Egalet A/S Morphine polymer release system
US20040234602A1 (en) 2001-09-21 2004-11-25 Gina Fischer Polymer release system
WO2004041252A1 (en) 2002-11-08 2004-05-21 Egalet A/S Controlled release carvedilol compositions
DE602004031096D1 (en) 2003-03-26 2011-03-03 Egalet As MORPHINE SYSTEM WITH CONTROLLED RELEASE
US8298581B2 (en) 2003-03-26 2012-10-30 Egalet A/S Matrix compositions for controlled delivery of drug substances
JP2007512350A (en) * 2003-11-25 2007-05-17 エスビー・ファルムコ・プエルト・リコ・インコーポレイテッド Carvedilol composition treatment and delivery methods
ES2662903T3 (en) * 2003-11-25 2018-04-10 Smithkline Beecham (Cork) Limited Carvedilol-free base, salts, anhydrous or solvate forms thereof, corresponding pharmaceutical compositions, controlled release formulations, and treatment or administration procedures
AU2006216420B2 (en) 2005-02-25 2010-07-15 The Regents Of The University Of Michigan Compositions and methods for treating and preventing cardiomyopathy and heart disease
HU227490B1 (en) * 2005-08-26 2011-07-28 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Sustained release pharmaceutical preparation containing carvedilol
AU2007281531B2 (en) 2006-08-01 2013-07-04 Phrixus Pharmaceuticals, Incorporated Use of poloxamer for the prevention and/or treatment of heart failure
HU227881B1 (en) * 2007-02-23 2012-05-29 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Sustained release pharmaceutical preparation containing carvedilol
WO2008114276A1 (en) * 2007-03-16 2008-09-25 Lupin Limited Novel oral controlled release composition of carvedilol
JP2010523569A (en) 2007-04-05 2010-07-15 フリクサス ファーマシューティカルズ， インコーポレイテッド Compositions and methods for treating heart failure
AU2008258596B2 (en) 2007-06-04 2013-02-14 Egalet Ltd Controlled release pharmaceutical compositions for prolonged effect
FR2936709B1 (en) * 2008-10-02 2012-05-11 Ethypharm Sa ALCOHOL-RESISTANT TABLETS.
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
NZ603579A (en) 2009-06-24 2014-02-28 Egalet Ltd Controlled release formulations
TWI415604B (en) * 2009-09-29 2013-11-21 Tsh Biopharm Corp Ltd Regulated release of caffetilol dosage form
NZ704011A (en) 2012-07-06 2016-04-29 Egalet Ltd Abuse deterrent pharmaceutical compositions for controlled release

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19816036A1 (en) * 1998-04-09 1999-10-14 Roche Diagnostics Gmbh Production of pharmaceutical preparations with high disintegration rate containing difficultly soluble active ingredient, e.g. carvedilol
WO2000000179A1 (en) * 1998-06-27 2000-01-06 Won Jin Biopharma Co., Ltd. Solid dispersed preparation of poorly water-soluble drug containing oil, fatty acid or mixtures thereof
WO2000004902A1 (en) * 1998-07-23 2000-02-03 Roche Diagnostics Gmbh Stabilized carvedilol injection solution
WO2000032174A2 (en) * 1998-11-27 2000-06-08 F. Hoffmann-La Roche Ag Pharmaceutical combination preparations of carvedilol and hydrochlorothiazide
WO2001035958A1 (en) * 1999-11-15 2001-05-25 Smithkline Beecham Corporation Carvedilol methanesulfonate
WO2001074356A1 (en) * 2000-04-03 2001-10-11 F. Hoffmann-La Roche Ag Concentrated solutions of carvedilol

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19637082A1 (en) * 1996-09-12 1998-03-19 Boehringer Mannheim Gmbh Rapidly disintegrating pellets
CN1251987A (en) * 1997-03-11 2000-05-03 达尔文发现有限公司 Dasage forms comprising separate portions of R- and S-enantiomers

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19816036A1 (en) * 1998-04-09 1999-10-14 Roche Diagnostics Gmbh Production of pharmaceutical preparations with high disintegration rate containing difficultly soluble active ingredient, e.g. carvedilol
WO2000000179A1 (en) * 1998-06-27 2000-01-06 Won Jin Biopharma Co., Ltd. Solid dispersed preparation of poorly water-soluble drug containing oil, fatty acid or mixtures thereof
WO2000004902A1 (en) * 1998-07-23 2000-02-03 Roche Diagnostics Gmbh Stabilized carvedilol injection solution
WO2000032174A2 (en) * 1998-11-27 2000-06-08 F. Hoffmann-La Roche Ag Pharmaceutical combination preparations of carvedilol and hydrochlorothiazide
WO2001035958A1 (en) * 1999-11-15 2001-05-25 Smithkline Beecham Corporation Carvedilol methanesulfonate
WO2001074356A1 (en) * 2000-04-03 2001-10-11 F. Hoffmann-La Roche Ag Concentrated solutions of carvedilol

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO02065834A3 *

Also Published As

Publication number Publication date
WO2002065834A8 (en) 2003-06-26
WO2002065834A3 (en) 2002-10-03
CA2426811A1 (en) 2002-08-29
WO2002065834A2 (en) 2002-08-29
JP2004518734A (en) 2004-06-24
EP1335707A2 (en) 2003-08-20
AU2001297631A1 (en) 2002-09-04
AU2001297631A8 (en) 2005-09-15

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Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20030519

AK Designated contracting states

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

A4 Supplementary search report drawn up and despatched

Effective date: 20050523

RIC1 Information provided on ipc code assigned before grant

Ipc: 7A 61K 31/403 B

Ipc: 7A 61K 9/62 B

Ipc: 7A 61K 9/58 B

Ipc: 7A 61K 9/52 B

Ipc: 7A 61K 9/30 B

Ipc: 7A 61K 9/26 B

Ipc: 7A 61K 9/22 A

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20070430