DE69811855D1 - Fenofibrathaltige arzneizusammensetzung mit hoher bioverfügbarkeit und herstellungsverfahren - Google Patents

Fenofibrathaltige arzneizusammensetzung mit hoher bioverfügbarkeit und herstellungsverfahren

Info

Publication number
DE69811855D1
DE69811855D1 DE69811855T DE69811855T DE69811855D1 DE 69811855 D1 DE69811855 D1 DE 69811855D1 DE 69811855 T DE69811855 T DE 69811855T DE 69811855 T DE69811855 T DE 69811855T DE 69811855 D1 DE69811855 D1 DE 69811855D1
Authority
DE
Germany
Prior art keywords
biovavailability
fenofibrate
production method
medicinal composition
containing medicinal
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.)
Expired - Lifetime
Application number
DE69811855T
Other languages
English (en)
Other versions
DE69811855T2 (de
Inventor
Andre Stamm
Pawan Seth
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.)
Laboratories Fournier SAS
Original Assignee
Laboratories Fournier SAS
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=9502710&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69811855(D1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Laboratories Fournier SAS filed Critical Laboratories Fournier SAS
Publication of DE69811855D1 publication Critical patent/DE69811855D1/de
Application granted granted Critical
Publication of DE69811855T2 publication Critical patent/DE69811855T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K31/12—Ketones
    • 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
    • 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
    • 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
    • A61K9/20—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61K9/1617—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
    • A61K9/1635—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
    • A61K9/20—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
    • 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
DE69811855T 1997-01-17 1998-01-16 Fenofibrathaltige arzneizusammensetzung mit hoher bioverfügbarkeit und herstellungsverfahren Expired - Lifetime DE69811855T2 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9700479A FR2758459B1 (fr) 1997-01-17 1997-01-17 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
PCT/IB1998/000065 WO1998031361A1 (fr) 1997-01-17 1998-01-16 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Publications (2)

Publication Number Publication Date
DE69811855D1 true DE69811855D1 (de) 2003-04-10
DE69811855T2 DE69811855T2 (de) 2003-12-18

Family

ID=9502710

Family Applications (5)

Application Number Title Priority Date Filing Date
DE29825080U Expired - Lifetime DE29825080U1 (de) 1997-01-17 1998-01-16 Pharmazeutische Fenofibratzusammensetzung mit erhöhter Bioverfügbarkeit
DE69834437T Expired - Lifetime DE69834437T2 (de) 1997-01-17 1998-01-16 Verfahren zur Herstellung von Fenofibrathaltigen Arzneizusammensetzungen mit erhöhter Bioverfügbarkeit
DE69811855T Expired - Lifetime DE69811855T2 (de) 1997-01-17 1998-01-16 Fenofibrathaltige arzneizusammensetzung mit hoher bioverfügbarkeit und herstellungsverfahren
DE69832108T Expired - Lifetime DE69832108T2 (de) 1997-01-17 1998-01-16 Fenofibrathaltige Arzneizusammensetzung mit erhöhter Bioverfügbarkeit und Verfahren zu deren Herstellung
DE69829591T Expired - Lifetime DE69829591T2 (de) 1997-01-17 1998-01-16 Fenofibrathaltige Suspension in einer hydrophilen Polymerlösung

Family Applications Before (2)

Application Number Title Priority Date Filing Date
DE29825080U Expired - Lifetime DE29825080U1 (de) 1997-01-17 1998-01-16 Pharmazeutische Fenofibratzusammensetzung mit erhöhter Bioverfügbarkeit
DE69834437T Expired - Lifetime DE69834437T2 (de) 1997-01-17 1998-01-16 Verfahren zur Herstellung von Fenofibrathaltigen Arzneizusammensetzungen mit erhöhter Bioverfügbarkeit

Family Applications After (2)

Application Number Title Priority Date Filing Date
DE69832108T Expired - Lifetime DE69832108T2 (de) 1997-01-17 1998-01-16 Fenofibrathaltige Arzneizusammensetzung mit erhöhter Bioverfügbarkeit und Verfahren zu deren Herstellung
DE69829591T Expired - Lifetime DE69829591T2 (de) 1997-01-17 1998-01-16 Fenofibrathaltige Suspension in einer hydrophilen Polymerlösung

Country Status (36)

Country Link
US (18) US6074670A (de)
EP (6) EP1468681A1 (de)
JP (6) JP4219988B2 (de)
KR (2) KR100391104B1 (de)
CN (2) CN1496738B (de)
AR (1) AR011411A1 (de)
AT (4) ATE291911T1 (de)
BR (1) BR9806738A (de)
CA (5) CA2372561A1 (de)
CY (4) CY2396B1 (de)
CZ (1) CZ297251B6 (de)
DE (5) DE29825080U1 (de)
DK (5) DK1273293T3 (de)
DZ (1) DZ2398A1 (de)
EE (1) EE04042B1 (de)
EG (1) EG23978A (de)
ES (5) ES2195308T3 (de)
FR (1) FR2758459B1 (de)
HK (3) HK1023071A1 (de)
HU (3) HU230685B1 (de)
ID (1) ID22528A (de)
IL (1) IL130790A0 (de)
IN (1) IN187906B (de)
IS (1) IS5097A (de)
MA (1) MA26466A1 (de)
NO (2) NO329200B1 (de)
NZ (1) NZ336462A (de)
PL (1) PL194802B1 (de)
PT (4) PT2050445E (de)
RU (3) RU2238089C2 (de)
SK (1) SK285847B6 (de)
TN (1) TNSN98009A1 (de)
TR (1) TR199901660T2 (de)
UA (1) UA61096C2 (de)
WO (1) WO1998031361A1 (de)
ZA (1) ZA98324B (de)

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ID22528A (id) 1999-10-28
US8329214B2 (en) 2012-12-11
AR011411A1 (es) 2000-08-16
DK0952829T3 (da) 2003-06-23
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HUP0000808A3 (en) 2001-02-28
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US20030104051A1 (en) 2003-06-05
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NO329200B1 (no) 2010-09-13
IL130790A0 (en) 2001-01-28
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US6074670A (en) 2000-06-13
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FR2758459A1 (fr) 1998-07-24
EP1275387A1 (de) 2003-01-15
EP0952829A1 (de) 1999-11-03
ATE233556T1 (de) 2003-03-15
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JP4365343B2 (ja) 2009-11-18
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CY2513B1 (en) 2005-12-23
US20020114839A1 (en) 2002-08-22
WO1998031361A1 (fr) 1998-07-23
DE29825080U1 (de) 2004-11-04
AU5336798A (en) 1998-08-07
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US20080064759A1 (en) 2008-03-13
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US6277405B1 (en) 2001-08-21
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NO993519L (no) 1999-09-16
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ZA98324B (en) 1998-08-12
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RU2002109746A (ru) 2004-03-20
IN187906B (de) 2002-07-20
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ATE291911T1 (de) 2005-04-15
ATE307576T1 (de) 2005-11-15
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