BRPI0414860A - composição farmacêutica contendo fenofibrato e método para a preparação desta - Google Patents

composição farmacêutica contendo fenofibrato e método para a preparação desta

Info

Publication number
BRPI0414860A
BRPI0414860A BRPI0414860-6A BRPI0414860A BRPI0414860A BR PI0414860 A BRPI0414860 A BR PI0414860A BR PI0414860 A BRPI0414860 A BR PI0414860A BR PI0414860 A BRPI0414860 A BR PI0414860A
Authority
BR
Brazil
Prior art keywords
fenofibrate
composition
preparation
surfactant
active layer
Prior art date
Application number
BRPI0414860-6A
Other languages
English (en)
Inventor
Bruno Criere
Pascal Suplie
Philippe Chenevier
Pascal Oury
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0414860(A) "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 BRPI0414860A publication Critical patent/BRPI0414860A/pt
Publication of BRPI0414860B1 publication Critical patent/BRPI0414860B1/pt
Publication of BRPI0414860B8 publication Critical patent/BRPI0414860B8/pt

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

"COMPOSIçãO FARMACêUTICA CONTENDO FENOFIBRATO E MéTODO PARA A PREPARAçãO DESTA". A invenção refere-se ao uso de uma composição de fenofibrato contendo fenofibrato micronizado, um tensoativo e um derivado de celulose de ligação como um adjuvante de solubilização, a referida composição contendo uma quantidade de fenofibrato maior do que ou igual a 60% em peso, para a preparação de um medicamento para tratar hipertrigliceridemias, hipercolesterolemias ou hiperlipidemias ao mesmo tempo que enquanto reduzindo o efeito da alimentação sobre a biodisponibilidade do fenofibrato. A invenção é da mesma forma relacionada a uma composição de liberação imediata na forma de grânulos compreendendo: (a) um núcleo neutro; (b) uma camada ativa, que cerca o núcleo; e (c) uma camada externa; em que a referida camada ativa compreende fenofibrato micronizado, um tensoativo e um derivado de celulose de ligação; e em que a referida composição tem um perfil de dissolução menor do que 10% em 5 minutos e maior do que 80% em 20 minutos de acordo com a Farmacopéia Européia em um meio de dissolução constituído por água com 0,025 M de lauril sulfato de sódio.
BRPI0414860A 2003-10-03 2004-10-01 uso de composição de fenofibrato em um medicamento para tratar hipertrigliceridemias, hipercolesterolemias ou hiperlipidemias ao mesmo tempo que reduzindo o efeito da alimentação sobre a biodisponibilidade de fenofibrato BRPI0414860B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/677,861 2003-10-03
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 (3)

Publication Number Publication Date
BRPI0414860A true BRPI0414860A (pt) 2006-11-28
BRPI0414860B1 BRPI0414860B1 (pt) 2019-01-15
BRPI0414860B8 BRPI0414860B8 (pt) 2021-05-25

Family

ID=34422141

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0414860A BRPI0414860B8 (pt) 2003-10-03 2004-10-01 uso de composição de fenofibrato em um medicamento para tratar hipertrigliceridemias, hipercolesterolemias ou hiperlipidemias ao mesmo tempo que reduzindo o efeito da alimentação sobre a biodisponibilidade de fenofibrato

Country Status (22)

Country Link
US (2) US7863331B2 (pt)
EP (2) EP1667666B9 (pt)
JP (1) JP5490354B2 (pt)
KR (1) KR101150235B1 (pt)
CN (1) CN100544712C (pt)
AT (1) ATE428408T1 (pt)
AU (1) AU2004277757B2 (pt)
BR (1) BRPI0414860B8 (pt)
CA (1) CA2540235C (pt)
CY (1) CY1109929T1 (pt)
DE (1) DE602004020641D1 (pt)
DK (1) DK1667666T3 (pt)
ES (1) ES2324670T3 (pt)
IL (1) IL174660A (pt)
MX (1) MXPA06003656A (pt)
NO (1) NO335933B1 (pt)
NZ (1) NZ546692A (pt)
PL (1) PL1667666T3 (pt)
PT (1) PT1667666E (pt)
SI (1) SI1667666T1 (pt)
WO (1) WO2005032526A1 (pt)
ZA (1) ZA200603504B (pt)

Families Citing this family (22)

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US7863331B2 (en) * 1999-07-09 2011-01-04 Ethypharm Pharmaceutical composition containing fenofibrate and method for the preparation thereof
FR2795961B1 (fr) * 1999-07-09 2004-05-28 Ethypharm Lab Prod Ethiques Composition pharmaceutique contenant du fenofibrate micronise, un tensioactif et un derive cellulosique liant et procede de preparation
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
KR20070094666A (ko) * 2005-02-25 2007-09-20 에프. 호프만-라 로슈 아게 약제 물질 분산성이 향상된 정제
BRPI0713533A2 (pt) * 2006-06-26 2012-04-17 Mutual Pharmaceutical Co formulações de agente ativo, métodos de fabricação, e métodos de uso
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
JP2013047282A (ja) * 2006-08-31 2013-03-07 Aska Pharmaceutical Co Ltd フェノフィブラート含有組成物
US20100159010A1 (en) * 2008-12-24 2010-06-24 Mutual Pharmaceutical Company, Inc. Active Agent Formulations, Methods of Making, and Methods of Use
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ES2673870T3 (es) * 2012-05-07 2018-06-26 Bristol-Myers Squibb Holdings Ireland Formulación de dosificación oral sólida de [(1S)-1-{[(2S,4R)-4-(7-cloro-4-metoxiisoquinolin-1-iloxi)-2-({(1R,2S)-1-[(ciclopropilsulfonil) carbamoil]-2-etenilciclopropil} carbamoil) pirrolidin-1-il] carbonil}-2,2-dimetil-propil] carbamato de 1,1-dimetiletilo
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Also Published As

Publication number Publication date
AU2004277757A1 (en) 2005-04-14
DE602004020641D1 (de) 2009-05-28
JP5490354B2 (ja) 2014-05-14
HK1084895A1 (en) 2006-08-11
CA2540235C (en) 2012-07-17
IL174660A (en) 2011-10-31
EP1667666A1 (en) 2006-06-14
PT1667666E (pt) 2009-06-15
KR20060123728A (ko) 2006-12-04
BRPI0414860B8 (pt) 2021-05-25
US20100112049A1 (en) 2010-05-06
MXPA06003656A (es) 2006-06-05
ZA200603504B (en) 2007-04-25
ES2324670T3 (es) 2009-08-12
US8529952B2 (en) 2013-09-10
EP2000133A2 (en) 2008-12-10
JP2007507486A (ja) 2007-03-29
EP1667666B9 (en) 2009-10-21
NZ546692A (en) 2010-03-26
PL1667666T3 (pl) 2009-09-30
US7863331B2 (en) 2011-01-04
DK1667666T3 (da) 2009-06-22
NO335933B1 (no) 2015-03-30
NO20061960L (no) 2006-05-03
BRPI0414860B1 (pt) 2019-01-15
AU2004277757B2 (en) 2010-03-04
CA2540235A1 (en) 2005-04-14
EP2000133A3 (en) 2009-05-13
IL174660A0 (en) 2006-08-20
SI1667666T1 (sl) 2009-08-31
CY1109929T1 (el) 2014-09-10
CN100544712C (zh) 2009-09-30
US20040137055A1 (en) 2004-07-15
KR101150235B1 (ko) 2012-07-05
EP1667666B1 (en) 2009-04-15
WO2005032526A1 (en) 2005-04-14
ATE428408T1 (de) 2009-05-15
CN1863518A (zh) 2006-11-15

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