CA2219475A1 - Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation - Google Patents

Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Info

Publication number
CA2219475A1
CA2219475A1 CA002219475A CA2219475A CA2219475A1 CA 2219475 A1 CA2219475 A1 CA 2219475A1 CA 002219475 A CA002219475 A CA 002219475A CA 2219475 A CA2219475 A CA 2219475A CA 2219475 A1 CA2219475 A1 CA 2219475A1
Authority
CA
Canada
Prior art keywords
fenofibrate
pharmaceutical composition
biodisponibility
presenting
preparation process
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.)
Granted
Application number
CA002219475A
Other languages
English (en)
Other versions
CA2219475C (fr
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.)
BGP Products Operations GmbH
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=CA2219475(A1) "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
Priority to CA002372576A priority Critical patent/CA2372576C/fr
Priority to CA002372561A priority patent/CA2372561A1/fr
Publication of CA2219475A1 publication Critical patent/CA2219475A1/fr
Application granted granted Critical
Publication of CA2219475C publication Critical patent/CA2219475C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • 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
    • 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
    • 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
    • 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
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • 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
    • A61K9/1617Organic 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
    • A61K9/14Particulate 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
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention a pour objet une composition de fénofibrate à libération immédiate comprenant: (a) un support inerte hydrosoluble recouvert d'au moins une couche contenant un principe actif fénofibrate sous forme micronisée une taille inférieure à 20 .mu.m, un polymère hydrophile et éventuellement un tensio-actif; ledit polymère hydrophile représentant au moins 20% en poids du poids de l'élément a); et (b) éventuellement une ou plusieurs phase(s) ou couche(s) externe(s). L'invention a encore pour objet son procédé de préparation.
CA002219475A 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation Expired - Lifetime CA2219475C (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA002372576A CA2372576C (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002372561A CA2372561A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

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
FR9700479 1997-01-17

Related Child Applications (2)

Application Number Title Priority Date Filing Date
CA002372561A Division CA2372561A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002372576A Division CA2372576C (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Publications (2)

Publication Number Publication Date
CA2219475A1 true CA2219475A1 (fr) 1998-07-17
CA2219475C CA2219475C (fr) 2002-07-09

Family

ID=9502710

Family Applications (5)

Application Number Title Priority Date Filing Date
CA002372576A Expired - Lifetime CA2372576C (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002448630A Abandoned CA2448630A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002372561A Abandoned CA2372561A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002219475A Expired - Lifetime CA2219475C (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002448623A Abandoned CA2448623A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Family Applications Before (3)

Application Number Title Priority Date Filing Date
CA002372576A Expired - Lifetime CA2372576C (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002448630A Abandoned CA2448630A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation
CA002372561A Abandoned CA2372561A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002448623A Abandoned CA2448623A1 (fr) 1997-01-17 1997-12-11 Composition pharmaceutique de fenofibrate presentant une biodisponibilite elevee et son procede de preparation

Country Status (36)

Country Link
US (18) US6074670A (fr)
EP (6) EP2050445B2 (fr)
JP (6) JP4219988B2 (fr)
KR (2) KR100415897B1 (fr)
CN (2) CN1278678C (fr)
AR (1) AR011411A1 (fr)
AT (4) ATE307576T1 (fr)
BR (1) BR9806738A (fr)
CA (5) CA2372576C (fr)
CY (4) CY2396B1 (fr)
CZ (1) CZ297251B6 (fr)
DE (5) DE69834437T2 (fr)
DK (5) DK1275387T3 (fr)
DZ (1) DZ2398A1 (fr)
EE (1) EE04042B1 (fr)
EG (1) EG23978A (fr)
ES (5) ES2241931T3 (fr)
FR (1) FR2758459B1 (fr)
HK (3) HK1023071A1 (fr)
HU (3) HU227758B1 (fr)
ID (1) ID22528A (fr)
IL (1) IL130790A0 (fr)
IN (1) IN187906B (fr)
IS (1) IS5097A (fr)
MA (1) MA26466A1 (fr)
NO (2) NO329200B1 (fr)
NZ (1) NZ336462A (fr)
PL (1) PL194802B1 (fr)
PT (4) PT952829E (fr)
RU (3) RU2196580C2 (fr)
SK (1) SK285847B6 (fr)
TN (1) TNSN98009A1 (fr)
TR (1) TR199901660T2 (fr)
UA (1) UA61096C2 (fr)
WO (1) WO1998031361A1 (fr)
ZA (1) ZA98324B (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7037529B2 (en) 1997-01-17 2006-05-02 Laboratoires Fournier Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it

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DE60210626T2 (de) 2001-08-07 2007-03-15 Laboratoires Smb Sa Verbesserte pharmazeutische zusammensetzung mit einem ppar-alpha-mittel und verfahren zu ihrer herstellung

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7037529B2 (en) 1997-01-17 2006-05-02 Laboratoires Fournier Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it
US7041319B2 (en) 1997-01-17 2006-05-09 Laboratoires Fournier Fenofibrate pharmaceutical composition having high bioavailabilty
US8329214B2 (en) 1997-01-17 2012-12-11 Laboratoires Fournier S.A. Process for producing fenofibrate tablets
US8343540B2 (en) 1997-01-17 2013-01-01 Laboratories Fournier S.A. Process for producing fenofibrate tablets

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PL334748A1 (en) 2000-03-13
EP2050445A2 (fr) 2009-04-22
US20030104051A1 (en) 2003-06-05
IS5097A (is) 1999-06-29
NO993519D0 (no) 1999-07-16
DE69829591T2 (de) 2006-02-09
ATE324885T1 (de) 2006-06-15
US20030104060A1 (en) 2003-06-05
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EP2050445B2 (fr) 2021-07-21
ES2241931T3 (es) 2005-11-01
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JP4943975B2 (ja) 2012-05-30
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NO329200B1 (no) 2010-09-13

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