ES2195308T3 - Composicon farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion. - Google Patents

Composicon farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion.

Info

Publication number
ES2195308T3
ES2195308T3 ES98900125T ES98900125T ES2195308T3 ES 2195308 T3 ES2195308 T3 ES 2195308T3 ES 98900125 T ES98900125 T ES 98900125T ES 98900125 T ES98900125 T ES 98900125T ES 2195308 T3 ES2195308 T3 ES 2195308T3
Authority
ES
Spain
Prior art keywords
phenofibrate
composition
preparation
biodisponibility
presents
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
ES98900125T
Other languages
English (en)
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=ES2195308(T3) "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
Application granted granted Critical
Publication of ES2195308T3 publication Critical patent/ES2195308T3/es
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

Landscapes

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

Abstract

LA INVENCION SE REFIERE A UNA COMPOSICION DE FENOFIBRATO CON LIBERACION INMEDIATA QUE COMPRENDE (A) UN SOPORTE INERTE HIDROSOLUBLE CUBIERTO POR AL MENOS UNA CAPA QUE CONTIENE UN PRINCIPIO ACTIVO DE FENOFIBRATO EN FORMA MICRONIZADA CON UNA DIMENSION INFERIOR A 20 MI M, UN POLIMERO HIDROFILO Y OPCIONALMENTE UN TENSIOACTIVO; REPRESENTANDO DICHO POLIMERO HIDROFILO AL MENOS UN 20% EN PESO DEL PESO DEL ELEMENTO A); Y (B) OPCIONALMENTE UNA O VARIAS FASES O CAPAS EXTERNAS. LA INVENCION SE REFIERE TAMBIEN A SU PROCEDIMIENTO DE PREPARACION.
ES98900125T 1997-01-17 1998-01-16 Composicon farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion. Expired - Lifetime ES2195308T3 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
ES2195308T3 true ES2195308T3 (es) 2003-12-01

Family

ID=9502710

Family Applications (5)

Application Number Title Priority Date Filing Date
ES08021428T Expired - Lifetime ES2427252T5 (es) 1997-01-17 1998-01-16 Composición farmacéutica de fenofibrato que presenta una biodisponibilidad elevada y procedimiento de preparación
ES02018029T Expired - Lifetime ES2254569T3 (es) 1997-01-17 1998-01-16 Composicion farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion.
ES98900125T Expired - Lifetime ES2195308T3 (es) 1997-01-17 1998-01-16 Composicon farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion.
ES02018031T Expired - Lifetime ES2263714T3 (es) 1997-01-17 1998-01-16 Composicion farmaceutica de fenofibrato que presenta biodisponibilidad elevada y procedicimiento para su preparacion.
ES02018028T Expired - Lifetime ES2241931T3 (es) 1997-01-17 1998-01-16 Suspension de fenofibrato en una solucion de polimero hidrofilo.

Family Applications Before (2)

Application Number Title Priority Date Filing Date
ES08021428T Expired - Lifetime ES2427252T5 (es) 1997-01-17 1998-01-16 Composición farmacéutica de fenofibrato que presenta una biodisponibilidad elevada y procedimiento de preparación
ES02018029T Expired - Lifetime ES2254569T3 (es) 1997-01-17 1998-01-16 Composicion farmaceutica de fenofibrato que presenta una biodisponibilidad elevada, y metodo para su preparacion.

Family Applications After (2)

Application Number Title Priority Date Filing Date
ES02018031T Expired - Lifetime ES2263714T3 (es) 1997-01-17 1998-01-16 Composicion farmaceutica de fenofibrato que presenta biodisponibilidad elevada y procedicimiento para su preparacion.
ES02018028T Expired - Lifetime ES2241931T3 (es) 1997-01-17 1998-01-16 Suspension de fenofibrato en una solucion de polimero hidrofilo.

Country Status (35)

Country Link
US (18) US6074670A (es)
EP (6) EP2050445B2 (es)
JP (6) JP4219988B2 (es)
KR (2) KR100415897B1 (es)
CN (2) CN1278678C (es)
AR (1) AR011411A1 (es)
AT (4) ATE233556T1 (es)
BR (1) BR9806738A (es)
CA (4) CA2372576C (es)
CY (4) CY2396B1 (es)
CZ (1) CZ297251B6 (es)
DE (5) DE69811855T2 (es)
DK (5) DK0952829T3 (es)
DZ (1) DZ2398A1 (es)
EE (1) EE04042B1 (es)
EG (1) EG23978A (es)
ES (5) ES2427252T5 (es)
FR (1) FR2758459B1 (es)
HU (3) HU230685B1 (es)
ID (1) ID22528A (es)
IL (1) IL130790A0 (es)
IN (1) IN187906B (es)
IS (1) IS5097A (es)
MA (1) MA26466A1 (es)
NO (2) NO329200B1 (es)
NZ (1) NZ336462A (es)
PL (1) PL194802B1 (es)
PT (4) PT1275387E (es)
RU (3) RU2196580C2 (es)
SK (1) SK285847B6 (es)
TN (1) TNSN98009A1 (es)
TR (1) TR199901660T2 (es)
UA (1) UA61096C2 (es)
WO (1) WO1998031361A1 (es)
ZA (1) ZA98324B (es)

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NO20100034L (no) 1999-09-16
US6074670A (en) 2000-06-13
EP1273293B1 (fr) 2005-03-30
PT2050445E (pt) 2013-08-23
JP2005206614A (ja) 2005-08-04
RU2238089C2 (ru) 2004-10-20
CA2219475A1 (fr) 1998-07-17
JP2001511156A (ja) 2001-08-07
HK1023071A1 (en) 2000-09-01
TR199901660T2 (xx) 1999-09-21
HU230685B1 (en) 2017-08-28
RU2196580C2 (ru) 2003-01-20
US20030104060A1 (en) 2003-06-05
DK2050445T4 (da) 2021-10-18
CN1278678C (zh) 2006-10-11
TNSN98009A1 (fr) 2005-03-15
US6277405B1 (en) 2001-08-21
DE69829591D1 (de) 2005-05-04
PT952829E (pt) 2003-07-31
US20020168413A1 (en) 2002-11-14
EP2050445B2 (fr) 2021-07-21
US20020114839A1 (en) 2002-08-22
HU228849B1 (hu) 2013-06-28
US20080064759A1 (en) 2008-03-13
JP4365343B2 (ja) 2009-11-18
ES2263714T3 (es) 2006-12-16
UA61096C2 (uk) 2003-11-17
ID22528A (id) 1999-10-28
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IS5097A (is) 1999-06-29
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ATE233556T1 (de) 2003-03-15
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US8343540B2 (en) 2013-01-01
CA2448630A1 (fr) 1998-07-17
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US20070184103A1 (en) 2007-08-09
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US20020009496A1 (en) 2002-01-24
US6589552B2 (en) 2003-07-08
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CA2372561A1 (fr) 1998-07-17
EP0952829A1 (fr) 1999-11-03
US20080063726A1 (en) 2008-03-13
AU731964B2 (en) 2001-04-05
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