ATE428408T1 - Pharmazeutische zusammensetzung mit fenofibrat und herstellungsverfahren dafür - Google Patents

Pharmazeutische zusammensetzung mit fenofibrat und herstellungsverfahren dafür

Info

Publication number: ATE428408T1
Authority: AT; Austria
Prior art keywords: fenofibrate; composition; composition containing; surfactant; pharmaceutical composition
Prior art date: 2003-10-03

Application number

AT04769636T

Other languages

English (en)

Inventor

Bruno Criere

Pascal Suplie

Philippe Chenevier

Pascal Oury

Keith 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.)

2003-10-03

Filing date

2004-10-01

Publication date

2009-05-15

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=ATE428408(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2004-10-01 Application filed by Ethypharm Sa filed Critical Ethypharm Sa

2009-05-15 Application granted granted Critical

2009-05-15 Publication of ATE428408T1 publication Critical patent/ATE428408T1/de

Links

YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 title abstract 6
229960002297 fenofibrate Drugs 0.000 title abstract 6
238000004519 manufacturing process Methods 0.000 title 1
239000008194 pharmaceutical composition Substances 0.000 title 1
239000000203 mixture Substances 0.000 abstract 4
229920002678 cellulose Polymers 0.000 abstract 2
239000001913 cellulose Substances 0.000 abstract 2
239000004094 surface-active agent Substances 0.000 abstract 2
208000035150 Hypercholesterolemia Diseases 0.000 abstract 1
208000031226 Hyperlipidaemia Diseases 0.000 abstract 1
DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 abstract 1
239000002671 adjuvant Substances 0.000 abstract 1
238000004090 dissolution Methods 0.000 abstract 1
239000012738 dissolution medium Substances 0.000 abstract 1
239000003814 drug Substances 0.000 abstract 1
230000009246 food effect Effects 0.000 abstract 1
235000021471 food effect Nutrition 0.000 abstract 1
239000008187 granular material Substances 0.000 abstract 1
208000006575 hypertriglyceridemia Diseases 0.000 abstract 1
239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
230000007935 neutral effect Effects 0.000 abstract 1
238000002360 preparation method Methods 0.000 abstract 1
235000019333 sodium laurylsulphate Nutrition 0.000 abstract 1
238000005063 solubilization Methods 0.000 abstract 1
230000007928 solubilization Effects 0.000 abstract 1
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1

Classifications

- 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
- A61K9/48—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
- 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)

AT04769636T 2003-10-03 2004-10-01 Pharmazeutische zusammensetzung mit fenofibrat und herstellungsverfahren dafür ATE428408T1 (de)

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 (1)

Publication Number	Publication Date
ATE428408T1 true ATE428408T1 (de)	2009-05-15

Family

ID=34422141

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
AT04769636T ATE428408T1 (de)	2003-10-03	2004-10-01	Pharmazeutische zusammensetzung mit fenofibrat und herstellungsverfahren dafür

Country Status (22)

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

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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
FR2940118B1 (fr) *	2008-12-24	2013-08-09	Ethypharm Sa	Formulation pharmaceutique de fenofibrate nanonise
WO2010078429A1 (en) *	2008-12-30	2010-07-08	Impax Laboratories, Inc.	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
CN101502497B (zh) *	2009-03-06	2010-11-10	安徽省药物研究所	非诺贝特药物组合物
US20110217369A1 (en) *	2009-09-03	2011-09-08	Ranbaxy Laboratories Limited	Fenofibrate compositions
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
US9439860B2 (en)	2012-06-25	2016-09-13	Mylan, Inc.	Fenofibrate formulation
WO2014003706A1 (en)	2012-06-25	2014-01-03	Mylan, Inc.	Fenofibrate formulation
US8722083B2 (en)	2012-06-25	2014-05-13	Mylan, Inc.	Fenofibrate formulation
WO2014091318A1 (en)	2012-12-11	2014-06-19	Lupin Atlantis Holdings, S.A.	Reduced dose pharmaceutical compositions of fenofibrate
WO2017027806A1 (en)	2015-08-13	2017-02-16	Coty Inc.	Formulation and method for promoting cutaneous uptake of molecular oxygen by skin

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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
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US8026281B2 (en)	2004-10-14	2011-09-27	Lupin Atlantis Holdings, S.A.	Treating metabolic syndrome with fenofibrate
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2003
- 2003-10-03 US US10/677,861 patent/US7863331B2/en not_active Expired - Lifetime
2004
- 2004-10-01 KR KR1020067006492A patent/KR101150235B1/ko not_active Expired - Lifetime
- 2004-10-01 SI SI200431122T patent/SI1667666T1/sl unknown
- 2004-10-01 BR BRPI0414860A patent/BRPI0414860B8/pt not_active IP Right Cessation
- 2004-10-01 DE DE602004020641T patent/DE602004020641D1/de not_active Expired - Lifetime
- 2004-10-01 AT AT04769636T patent/ATE428408T1/de active
- 2004-10-01 JP JP2006530759A patent/JP5490354B2/ja not_active Expired - Lifetime
- 2004-10-01 PL PL04769636T patent/PL1667666T3/pl unknown
- 2004-10-01 CA CA2540235A patent/CA2540235C/en not_active Expired - Lifetime
- 2004-10-01 EP EP04769636A patent/EP1667666B9/de not_active Expired - Lifetime
- 2004-10-01 DK DK04769636T patent/DK1667666T3/da active
- 2004-10-01 ES ES04769636T patent/ES2324670T3/es not_active Expired - Lifetime
- 2004-10-01 EP EP08165521A patent/EP2000133A3/de not_active Withdrawn
- 2004-10-01 CN CNB2004800287311A patent/CN100544712C/zh not_active Expired - Lifetime
- 2004-10-01 PT PT04769636T patent/PT1667666E/pt unknown
- 2004-10-01 MX MXPA06003656A patent/MXPA06003656A/es active IP Right Grant
- 2004-10-01 NZ NZ546692A patent/NZ546692A/en not_active IP Right Cessation
- 2004-10-01 AU AU2004277757A patent/AU2004277757B2/en not_active Expired
- 2004-10-01 WO PCT/IB2004/003354 patent/WO2005032526A1/en not_active Ceased
2006
- 2006-03-30 IL IL174660A patent/IL174660A/en active IP Right Grant
- 2006-05-03 NO NO20061960A patent/NO335933B1/no unknown
- 2006-05-03 ZA ZA200603504A patent/ZA200603504B/en unknown
2009
- 2009-06-30 CY CY20091100684T patent/CY1109929T1/el unknown
2010
- 2010-01-13 US US12/686,574 patent/US8529952B2/en not_active Expired - Fee Related

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 (de)	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 (de)	2008-12-10
JP2007507486A (ja)	2007-03-29
EP1667666B9 (de)	2009-10-21
NZ546692A (en)	2010-03-26
PL1667666T3 (pl)	2009-09-30
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