CA2582403A1 - Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine - Google Patents

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

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Publication number
CA2582403A1
CA2582403A1 CA002582403A CA2582403A CA2582403A1 CA 2582403 A1 CA2582403 A1 CA 2582403A1 CA 002582403 A CA002582403 A CA 002582403A CA 2582403 A CA2582403 A CA 2582403A CA 2582403 A1 CA2582403 A1 CA 2582403A1
Authority
CA
Canada
Prior art keywords
fenofibrate
atorvastatin
dosage form
vehicle
pharmaceutical composition
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.)
Abandoned
Application number
CA002582403A
Other languages
English (en)
Inventor
Per Holm
Tomas Norling
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.)
Lifecycle Pharma AS
Original Assignee
Lifecycle Pharma A/S
Per Holm
Tomas Norling
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, Per Holm, Tomas Norling filed Critical Lifecycle Pharma A/S
Publication of CA2582403A1 publication Critical patent/CA2582403A1/fr
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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

Landscapes

  • 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)
CA002582403A 2004-10-01 2005-10-03 Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine Abandoned CA2582403A1 (fr)

Applications Claiming Priority (11)

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
PCT/DK2005/050001 WO2006037344A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine

Publications (1)

Publication Number Publication Date
CA2582403A1 true CA2582403A1 (fr) 2006-04-13

Family

ID=35726678

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002582403A Abandoned CA2582403A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques comprenant du fenofibrate et de l'atorvastatine
CA002582405A Abandoned CA2582405A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002582405A Abandoned CA2582405A1 (fr) 2004-10-01 2005-10-03 Compositions pharmaceutiques contenant du fenofibrate et de l'atorvastatine

Country Status (3)

Country Link
EP (2) EP1804769A1 (fr)
CA (2) CA2582403A1 (fr)
WO (2) WO2006037344A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2007009281A (es) * 2005-02-10 2007-09-25 Lufecycle Pharma As Composicion farmaceutica estable que comprende una combinacion de dosis fija de fenofibrato y un inhibidor de 3-hidroxi 3-metilglutaril-coenzima a reductasa.
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
US20110097414A1 (en) * 2007-02-26 2011-04-28 Sandal Roshan Lal Pharmaceutical compositions comprising adsorbate of fenofibrate
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
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
EP2478019B1 (fr) * 2009-09-17 2015-04-01 Basf Se Granules recouvertes d'enrobages renfermant des substances actives
US20110217289A1 (en) * 2010-03-05 2011-09-08 Basf Se Melt-Coated Dosage Forms
EP2542222A2 (fr) * 2010-03-05 2013-01-09 Basf Se Formes pharmaceutiques enrobees d'une matiere fondue
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
KR20230079187A (ko) 2020-09-29 2023-06-05 라보라토리오스 실레인즈, 에스.에이. 드 씨.브이. 고지혈증 및 심혈관 질환의 치료 및 예방을 위한 스타틴 및 피브레이트의 약학적 병용

Family Cites Families (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
BR0210867A (pt) * 2001-07-06 2004-06-29 Lifecycle Pharma As Processo para a preparação de um material particulado, métodos para aglomeração controlada de um material sólido finamente disperso, para melhorar a biodisponibilidade de uma substância terapêutica e/ou profilaticamente ativa, e para melhorar a vida em prateleira de uma composição farmacêutica, material articulado, composição farmacêutica, uso de um veìculo, material particulado farmacêutico, e, uso de aluminossilicato de magnésio e/ou de aluminometassilicato de magnésio
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
JP2006517929A (ja) * 2003-02-19 2006-08-03 ハー・ルンドベック・アクチエゼルスカベット 溶融アグロメレーションを用いてアグロメレートを製造する方法
KR20060085682A (ko) * 2003-10-10 2006-07-27 라이프사이클 파마 에이/에스 피브레이트 및 스타틴을 함유하는 고형 제제

Also Published As

Publication number Publication date
EP1804769A1 (fr) 2007-07-11
CA2582405A1 (fr) 2006-04-13
WO2006037347A1 (fr) 2006-04-13
WO2006037344A1 (fr) 2006-04-13
EP1804768A1 (fr) 2007-07-11

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Dead