NO20061960L - Farmasoytisk sammensetning som inneholder fenofibrat og fremgangsmate til fremstilling derav - Google Patents

Farmasoytisk sammensetning som inneholder fenofibrat og fremgangsmate til fremstilling derav

Info

Publication number
NO20061960L
NO20061960L NO20061960A NO20061960A NO20061960L NO 20061960 L NO20061960 L NO 20061960L NO 20061960 A NO20061960 A NO 20061960A NO 20061960 A NO20061960 A NO 20061960A NO 20061960 L NO20061960 L NO 20061960L
Authority
NO
Norway
Prior art keywords
fenofibrate
composition
preparation
composition containing
surfactant
Prior art date
Application number
NO20061960A
Other languages
English (en)
Other versions
NO335933B1 (no
Inventor
Pascal Suplie
Bruno Criere
Pascal Oury
Philippe Chenevier
Keith S Rotenberg
George Bobotas
Original Assignee
Ethypharm Sa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34422141&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO20061960(L) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ethypharm Sa filed Critical Ethypharm Sa
Publication of NO20061960L publication Critical patent/NO20061960L/no
Publication of NO335933B1 publication Critical patent/NO335933B1/no

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
    • A61K31/21—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
    • 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/501—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
    • A61K9/48—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

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

Abstract

Foreliggende oppfinnelse angår anvendelse av en sammensetning av fenofibrat som inneholder mikronisert fenofibrat, en surfaktant og et bindingscellulosederivat som et solubiliseringsadjuvans, hvor nevnte sammensetning inneholder en mengde av fenofibrat som er større enn eller lik 60 vekt% til fremstilling av et legemiddel for å behandle hypertriglyseridemier, hyperkolesterolemier eller hyperlipidemier mens det reduserer mateffekten på biotilgjengeligheten til fenofibrat. Oppfinnelsen angår også en sammensetning for øyeblikkelig frigjøring i form av granuler som omfatter: (a) en nøytral kjerne; (b) et aktivt lag som omgir kjernen; og (c) et ytre lag, hvori nevnte aktive lag omfatter mikronisert fenofibrat, en surfaktant og et bindingscellulosederivat; og hvori nevnte sammensetning har en oppløsningsprofil på mindre enn10 % ved 5 min. og mer enn 80 % ved 20 min. i henhold til den europeiske Pharmacopoeia i et oppløsningsmedium som består av vann med 0,025 M natriumlaurylsulfat.
NO20061960A 2003-10-03 2006-05-03 Anvendelse av en farmasøytisk sammensetning som inneholder fenofibrat. NO335933B1 (no)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/677,861 US7863331B2 (en) 1999-07-09 2003-10-03 Pharmaceutical composition containing fenofibrate and method for the preparation thereof
PCT/IB2004/003354 WO2005032526A1 (en) 2003-10-03 2004-10-01 Pharmaceutical composition containing fenofibrate and method for the preparation thereof

Publications (2)

Publication Number Publication Date
NO20061960L true NO20061960L (no) 2006-05-03
NO335933B1 NO335933B1 (no) 2015-03-30

Family

ID=34422141

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20061960A NO335933B1 (no) 2003-10-03 2006-05-03 Anvendelse av en farmasøytisk sammensetning som inneholder fenofibrat.

Country Status (23)

Country Link
US (2) US7863331B2 (no)
EP (2) EP2000133A3 (no)
JP (1) JP5490354B2 (no)
KR (1) KR101150235B1 (no)
CN (1) CN100544712C (no)
AT (1) ATE428408T1 (no)
AU (1) AU2004277757B2 (no)
BR (1) BRPI0414860B8 (no)
CA (1) CA2540235C (no)
CY (1) CY1109929T1 (no)
DE (1) DE602004020641D1 (no)
DK (1) DK1667666T3 (no)
ES (1) ES2324670T3 (no)
HK (1) HK1084895A1 (no)
IL (1) IL174660A (no)
MX (1) MXPA06003656A (no)
NO (1) NO335933B1 (no)
NZ (1) NZ546692A (no)
PL (1) PL1667666T3 (no)
PT (1) PT1667666E (no)
SI (1) SI1667666T1 (no)
WO (1) WO2005032526A1 (no)
ZA (1) ZA200603504B (no)

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US20080051411A1 (en) * 2002-12-17 2008-02-28 Cink Russell D Salts of Fenofibric Acid and Pharmaceutical Formulations Thereof
CN101480384A (zh) * 2002-12-17 2009-07-15 阿伯特有限及两合公司 包含非诺贝酸、其生理可接受的盐或衍生物的制剂
US8062664B2 (en) * 2003-11-12 2011-11-22 Abbott Laboratories Process for preparing formulations of lipid-regulating drugs
US8026281B2 (en) * 2004-10-14 2011-09-27 Lupin Atlantis Holdings, S.A. Treating metabolic syndrome with fenofibrate
EP2281556A1 (en) * 2005-02-25 2011-02-09 F. Hoffmann-La Roche AG Tablets with improved drugs substance dispersibility
CN101505733A (zh) * 2006-06-26 2009-08-12 共有药物有限公司 活性剂制剂及其制备和应用方法
JP5186159B2 (ja) * 2006-08-31 2013-04-17 あすか製薬株式会社 フェノフィブラート含有組成物
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FR2940118B1 (fr) * 2008-12-24 2013-08-09 Ethypharm Sa Formulation pharmaceutique de fenofibrate nanonise
US20100166857A1 (en) * 2008-12-30 2010-07-01 Dong Yan Pharmaceutical dosage forms and methods of manufacturing same
JPWO2010092925A1 (ja) * 2009-02-12 2012-08-16 あすか製薬株式会社 固体分散体とその医薬組成物、並びにそれらの製造方法
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Also Published As

Publication number Publication date
JP2007507486A (ja) 2007-03-29
EP1667666B1 (en) 2009-04-15
SI1667666T1 (sl) 2009-08-31
PL1667666T3 (pl) 2009-09-30
DE602004020641D1 (de) 2009-05-28
US8529952B2 (en) 2013-09-10
HK1084895A1 (en) 2006-08-11
NO335933B1 (no) 2015-03-30
CA2540235A1 (en) 2005-04-14
DK1667666T3 (da) 2009-06-22
EP2000133A2 (en) 2008-12-10
KR20060123728A (ko) 2006-12-04
CN100544712C (zh) 2009-09-30
CA2540235C (en) 2012-07-17
EP1667666B9 (en) 2009-10-21
AU2004277757B2 (en) 2010-03-04
NZ546692A (en) 2010-03-26
BRPI0414860A (pt) 2006-11-28
JP5490354B2 (ja) 2014-05-14
EP1667666A1 (en) 2006-06-14
EP2000133A3 (en) 2009-05-13
WO2005032526A1 (en) 2005-04-14
CN1863518A (zh) 2006-11-15
US20040137055A1 (en) 2004-07-15
IL174660A (en) 2011-10-31
ZA200603504B (en) 2007-04-25
PT1667666E (pt) 2009-06-15
ES2324670T3 (es) 2009-08-12
AU2004277757A1 (en) 2005-04-14
BRPI0414860B1 (pt) 2019-01-15
US7863331B2 (en) 2011-01-04
CY1109929T1 (el) 2014-09-10
KR101150235B1 (ko) 2012-07-05
BRPI0414860B8 (pt) 2021-05-25
MXPA06003656A (es) 2006-06-05
US20100112049A1 (en) 2010-05-06
IL174660A0 (en) 2006-08-20
ATE428408T1 (de) 2009-05-15

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