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FR2977495B1 - Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation - Google Patents

Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation

Info

Publication number
FR2977495B1
FR2977495B1 FR1156153A FR1156153A FR2977495B1 FR 2977495 B1 FR2977495 B1 FR 2977495B1 FR 1156153 A FR1156153 A FR 1156153A FR 1156153 A FR1156153 A FR 1156153A FR 2977495 B1 FR2977495 B1 FR 2977495B1
Authority
FR
France
Prior art keywords
dronedarone
preparing
content
pharmaceutical composition
same
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 - Fee Related
Application number
FR1156153A
Other languages
English (en)
Other versions
FR2977495A1 (fr
Inventor
Jean Ducassou
Marie Renouard
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.)
Sanofi SA
Original Assignee
Sanofi 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
Application filed by Sanofi SA filed Critical Sanofi SA
Priority to FR1156153A priority Critical patent/FR2977495B1/fr
Priority to KR1020147002922A priority patent/KR20140046011A/ko
Priority to CN201280042989.1A priority patent/CN103764126A/zh
Priority to US14/131,310 priority patent/US20140148507A1/en
Priority to PCT/EP2012/063312 priority patent/WO2013004830A1/fr
Priority to EP12733700.4A priority patent/EP2729132A1/fr
Publication of FR2977495A1 publication Critical patent/FR2977495A1/fr
Application granted granted Critical
Publication of FR2977495B1 publication Critical patent/FR2977495B1/fr
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61P9/06—Antiarrhythmics

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
FR1156153A 2011-07-07 2011-07-07 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation Expired - Fee Related FR2977495B1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
FR1156153A FR2977495B1 (fr) 2011-07-07 2011-07-07 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation
KR1020147002922A KR20140046011A (ko) 2011-07-07 2012-07-06 고 함량의 드로네다론을 포함하는 약학적 조성물 및 고형 생약 제제 및 이의 제조 방법
CN201280042989.1A CN103764126A (zh) 2011-07-07 2012-07-06 具有高决奈达隆含量的药物组合物和固体盖伦形式及它们的制备方法
US14/131,310 US20140148507A1 (en) 2011-07-07 2012-07-06 Pharmaceutical composition and solid galenic form having a high dronedarone content, and method for preparing same
PCT/EP2012/063312 WO2013004830A1 (fr) 2011-07-07 2012-07-06 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation
EP12733700.4A EP2729132A1 (fr) 2011-07-07 2012-07-06 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1156153A FR2977495B1 (fr) 2011-07-07 2011-07-07 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation

Publications (2)

Publication Number Publication Date
FR2977495A1 FR2977495A1 (fr) 2013-01-11
FR2977495B1 true FR2977495B1 (fr) 2014-03-07

Family

ID=46506382

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1156153A Expired - Fee Related FR2977495B1 (fr) 2011-07-07 2011-07-07 Composition pharmaceutique et forme galenique solide a haute teneur en dronedarone et son procede de preparation

Country Status (6)

Country Link
US (1) US20140148507A1 (fr)
EP (1) EP2729132A1 (fr)
KR (1) KR20140046011A (fr)
CN (1) CN103764126A (fr)
FR (1) FR2977495B1 (fr)
WO (1) WO2013004830A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105708809B (zh) * 2015-05-09 2018-07-31 张秋野 一种控缓释剂药用辅料的热熔融制粒方法
FR3039990B1 (fr) * 2015-08-10 2018-07-06 Rhodia Operations Procede d'encapsulation
CN108042500A (zh) * 2017-12-19 2018-05-18 佛山市弘泰药物研发有限公司 一种盐酸决奈达隆口崩片及其制备方法
CN112137999A (zh) * 2020-09-30 2020-12-29 郑州大学 盐酸决奈达隆在制备抗消化道肿瘤药物中的应用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2665444B1 (fr) 1990-08-06 1992-11-27 Sanofi Sa Derives d'amino-benzofuranne, benzothiophene ou indole, leur procede de preparation ainsi que les compositions les contenant.
IE920860A1 (en) * 1991-03-19 1992-09-23 Cytrx Corp Polyoxypropylene/polyoxyethylene copolymers with improved¹biological activity
FR2764800B1 (fr) * 1997-06-23 1999-09-10 Sanofi Sa Composition pharmaceutique solide contenant des derives de benzofuranne
EP2133074A1 (fr) * 2008-06-10 2009-12-16 Sanofi-Aventis Utilisation de dronédarone pour la préparation d'un médicament destiné à la prévention de la fibrillation auriculaire permanente
CN102078307B (zh) * 2009-12-01 2012-11-07 天津市汉康医药生物技术有限公司 一种盐酸决奈达隆固体分散体的药物组合物及其制备方法
WO2011135581A2 (fr) * 2010-04-28 2011-11-03 Cadila Healthcare Limited Compositions pharmaceutiques de dronédarone
CN102342907A (zh) * 2010-07-30 2012-02-08 江苏恒瑞医药股份有限公司 决奈达隆固体分散体及其制备方法

Also Published As

Publication number Publication date
KR20140046011A (ko) 2014-04-17
FR2977495A1 (fr) 2013-01-11
EP2729132A1 (fr) 2014-05-14
US20140148507A1 (en) 2014-05-29
WO2013004830A1 (fr) 2013-01-10
CN103764126A (zh) 2014-04-30

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