WO2006037347A1 - Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine - Google Patents

Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine Download PDF

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Publication number
WO2006037347A1
WO2006037347A1 PCT/DK2005/050004 DK2005050004W WO2006037347A1 WO 2006037347 A1 WO2006037347 A1 WO 2006037347A1 DK 2005050004 W DK2005050004 W DK 2005050004W WO 2006037347 A1 WO2006037347 A1 WO 2006037347A1
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WO
WIPO (PCT)
Prior art keywords
fenofibrate
atorvastatin
dosage form
vehicle
pharmaceutical composition
Prior art date
Application number
PCT/DK2005/050004
Other languages
English (en)
Inventor
Per Holm
Tomas Norling
Original Assignee
Lifecycle Pharma A/S
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 Lifecycle Pharma A/S filed Critical Lifecycle Pharma A/S
Priority to EP05789000A priority Critical patent/EP1804768A1/fr
Priority to CA002582405A priority patent/CA2582405A1/fr
Publication of WO2006037347A1 publication Critical patent/WO2006037347A1/fr
Priority to US11/449,918 priority patent/US9173847B2/en
Priority to US11/456,566 priority patent/US20070014846A1/en

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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques sous forme particulaire ou sous forme de dosage solide contenant une combinaison d'une dose réduite ou faible de fénofibrate et d'atorvastatine inhibitrice de réductase HMG CoA ou un sel de cette composition actif sur le plan pharmaceutique. L'atorvastatine est éventuellement fournie sous forme de formulation à libération contrôlée ou à libération retardée, ce qui peut entraîner un effet d'abaissement du LDL maintenu à un dosage réduit. Le fénofibrate est alimenté sous forme de formulation bioéquivalente aux capsules Antara® disponibles dans le commerce, ou offre une biodisponibilité améliorée par rapport à celles-ci, ainsi qu'un effet alimentaire réduit.
PCT/DK2005/050004 2003-10-10 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine WO2006037347A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP05789000A EP1804768A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine
CA002582405A CA2582405A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine
US11/449,918 US9173847B2 (en) 2003-10-10 2006-06-09 Tablet comprising a fibrate
US11/456,566 US20070014846A1 (en) 2003-10-10 2006-07-11 Pharmaceutical compositions comprising fenofibrate and atorvastatin

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
DKPA200401506 2004-10-01
DKPA200401506 2004-10-01
DKPA200401761 2004-11-15
DKPA200401761 2004-11-15
DKPA200402004 2004-12-23
DKPA200402004 2004-12-23
DKPA200500196 2005-02-09
DKPA200500196 2005-02-09
DKPA200500534 2005-04-13
DKPA200500534 2005-04-13

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/449,918 Continuation-In-Part US9173847B2 (en) 2003-10-10 2006-06-09 Tablet comprising a fibrate

Publications (1)

Publication Number Publication Date
WO2006037347A1 true WO2006037347A1 (fr) 2006-04-13

Family

ID=35726678

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/DK2005/050001 WO2006037344A1 (fr) 2003-10-10 2005-10-03 Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine
PCT/DK2005/050004 WO2006037347A1 (fr) 2003-10-10 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/DK2005/050001 WO2006037344A1 (fr) 2003-10-10 2005-10-03 Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine

Country Status (3)

Country Link
EP (2) EP1804769A1 (fr)
CA (2) CA2582405A1 (fr)
WO (2) WO2006037344A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008104852A2 (fr) * 2007-02-26 2008-09-04 Wockhardt Research Centre Compositions pharmaceutiques comprenant un adsorbate de fénofibrate
WO2008117154A2 (fr) * 2007-03-26 2008-10-02 Torrent Pharmaceuticals Limited Compositions pharmaceutiques stables d'inhibiteur de hmg-coa réductase et leur procédé de préparation
CN102525942A (zh) * 2012-01-05 2012-07-04 金陵药业股份有限公司 一种阿托伐他汀钙肠溶微丸及其制备方法

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006084474A2 (fr) * 2005-02-10 2006-08-17 Lifecycle Pharma A/S Preparation pharmaceutique stable comprenant une dose fixe de fenofibrate et d'un inhibiteur de la hmg-coa reductase
US7569612B1 (en) 2006-08-21 2009-08-04 Mutual Pharmaceutical Company, Inc. Methods of use of fenofibric acid
WO2008075320A2 (fr) * 2006-12-21 2008-06-26 Ranbaxy Laboratories Limited Compositions pharmaceutiques antilipidémiques et leur procédé de préparation
EP2307053A2 (fr) * 2008-06-06 2011-04-13 Nicox S.A. Compositions comprenant de l'ester 4-(nitrooxy)butylique d'atorvastatine et un médicament hypolipidémique
JP5758899B2 (ja) * 2009-09-17 2015-08-05 ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ 活性物質を含有するコーティングにより被覆されたペレット
JP2013521249A (ja) * 2010-03-05 2013-06-10 ビーエーエスエフ ソシエタス・ヨーロピア 融解物で被覆された医薬形態
US20110217289A1 (en) * 2010-03-05 2011-09-08 Basf Se Melt-Coated Dosage Forms
PE20240141A1 (es) 2020-09-29 2024-02-01 Laboratorios Silanes S A De C V Combinaciones farmaceuticas de estatinas y fibratos para el tratamiento y prevencion de hiperlipidemias y enfermedades cardiovasculares

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002024169A1 (fr) * 2000-09-20 2002-03-28 Skyepharma Canada Inc. Procede de sechage par atomisation et compositions de fenofibrate
WO2003004001A1 (fr) * 2001-07-06 2003-01-16 Lifecycle Pharma A/S Agglomeration controlee
US20030162827A1 (en) * 2002-01-30 2003-08-28 Suresh Venkataram HMG CoA reductase inhibiting composition, method of preparation thereof and method for competitively inhibiting HMG CoA reductase using such composition
WO2004073687A1 (fr) * 2003-02-19 2004-09-02 H. Lundbeck A/S Procede de preparation d'un agglomere par agglomeration a chaud
WO2005034908A2 (fr) * 2003-10-10 2005-04-21 Lifecycle Pharma A/S Forme posologique solide comprenant une fibrate et une statine

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002024169A1 (fr) * 2000-09-20 2002-03-28 Skyepharma Canada Inc. Procede de sechage par atomisation et compositions de fenofibrate
WO2003004001A1 (fr) * 2001-07-06 2003-01-16 Lifecycle Pharma A/S Agglomeration controlee
US20030162827A1 (en) * 2002-01-30 2003-08-28 Suresh Venkataram HMG CoA reductase inhibiting composition, method of preparation thereof and method for competitively inhibiting HMG CoA reductase using such composition
WO2004073687A1 (fr) * 2003-02-19 2004-09-02 H. Lundbeck A/S Procede de preparation d'un agglomere par agglomeration a chaud
WO2005034908A2 (fr) * 2003-10-10 2005-04-21 Lifecycle Pharma A/S Forme posologique solide comprenant une fibrate et une statine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SHEU ET AL: "Characterization and dissolution of fenofibrate solid dispersion systems", INTERNATIONAL JOURNAL OF PHARMACEUTICS, AMSTERDAM, NL, vol. 103, no. 2, 1994, pages 137 - 146, XP002091325, ISSN: 0378-5173 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008104852A2 (fr) * 2007-02-26 2008-09-04 Wockhardt Research Centre Compositions pharmaceutiques comprenant un adsorbate de fénofibrate
WO2008104852A3 (fr) * 2007-02-26 2009-03-26 Wockhardt Research Center Compositions pharmaceutiques comprenant un adsorbate de fénofibrate
WO2008117154A2 (fr) * 2007-03-26 2008-10-02 Torrent Pharmaceuticals Limited Compositions pharmaceutiques stables d'inhibiteur de hmg-coa réductase et leur procédé de préparation
WO2008117154A3 (fr) * 2007-03-26 2009-10-22 Torrent Pharmaceuticals Limited Compositions pharmaceutiques stables d'inhibiteur de hmg-coa réductase et leur procédé de préparation
CN102525942A (zh) * 2012-01-05 2012-07-04 金陵药业股份有限公司 一种阿托伐他汀钙肠溶微丸及其制备方法

Also Published As

Publication number Publication date
EP1804769A1 (fr) 2007-07-11
EP1804768A1 (fr) 2007-07-11
CA2582403A1 (fr) 2006-04-13
WO2006037344A1 (fr) 2006-04-13
CA2582405A1 (fr) 2006-04-13

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