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MX2016007682A - Pharmaceutical composition comprising amorphous ivabradine. - Google Patents

Pharmaceutical composition comprising amorphous ivabradine.

Info

Publication number
MX2016007682A
MX2016007682A MX2016007682A MX2016007682A MX2016007682A MX 2016007682 A MX2016007682 A MX 2016007682A MX 2016007682 A MX2016007682 A MX 2016007682A MX 2016007682 A MX2016007682 A MX 2016007682A MX 2016007682 A MX2016007682 A MX 2016007682A
Authority
MX
Mexico
Prior art keywords
pharmaceutical composition
ivabradine
pharmaceutically acceptable
amorphous ivabradine
amorphous
Prior art date
Application number
MX2016007682A
Other languages
Spanish (es)
Other versions
MX363389B (en
Inventor
Álvarez Fernández Lisardo
Keltjens Rolf
Theodorus Henricus Eupen Van Jacobus
Murpani Deepak
Garcia Jimenez Sonia
Original Assignee
Synthon Bv
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 Synthon Bv filed Critical Synthon Bv
Publication of MX2016007682A publication Critical patent/MX2016007682A/en
Publication of MX363389B publication Critical patent/MX363389B/en

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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • C08B37/0015—Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/16—Cyclodextrin; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Polymers & Plastics (AREA)
  • Materials Engineering (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Hospice & Palliative Care (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a pharmaceutical composition comprising an inclusion complex of ivabradine, or a pharmaceutically acceptable salt thereof, in amorphous form in non-substituted β-cyclodextrin and one or more pharmaceutically acceptable excipients. The invention further relates to the use of said composition as a medicament, particularly in the treatment of stable angina pectoris and chronic heart failure.
MX2016007682A 2013-12-12 2014-10-21 Pharmaceutical composition comprising amorphous ivabradine. MX363389B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2013076429 2013-12-12
PCT/EP2014/072524 WO2015001133A1 (en) 2013-12-12 2014-10-21 Pharmaceutical composition comprising amorphous ivabradine

Publications (2)

Publication Number Publication Date
MX2016007682A true MX2016007682A (en) 2016-09-09
MX363389B MX363389B (en) 2019-03-20

Family

ID=51845386

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016007682A MX363389B (en) 2013-12-12 2014-10-21 Pharmaceutical composition comprising amorphous ivabradine.

Country Status (3)

Country Link
ES (1) ES2672472T3 (en)
MX (1) MX363389B (en)
WO (1) WO2015001133A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015145234A1 (en) * 2014-03-27 2015-10-01 Laboratorio Chimico Internazionale S.P.A. Ivabradine adsorbates
GB201621771D0 (en) * 2016-12-20 2017-02-01 Biogena (A P I) Ltd New salts of compounds and uses thereof
EP3366282B1 (en) * 2017-02-28 2025-10-01 Sanovel Ilac Sanayi ve Ticaret A.S. Solid oral pharmaceutical compositions of ivabradine
TR201703066A2 (en) * 2017-02-28 2018-09-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Solid oral pharmaceutical compositions of ivabradine
CN109875969B (en) * 2019-03-19 2021-02-09 扬子江药业集团北京海燕药业有限公司 Stable ivabradine hydrochloride tablet and preparation method thereof
CN115770248B (en) * 2022-12-07 2023-08-04 郑州大学第一附属医院 A kind of ivabradine hydrochloride preparation and preparation method thereof

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2681862B1 (en) 1991-09-27 1993-11-12 Adir Cie NOVELS (BENZOCYCLOALKYL) ALKYLAMINES, THEIR PREPARATION PROCESS, AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.
FR2868777B1 (en) 2004-04-13 2006-05-26 Servier Lab NOVEL PROCESS FOR THE SYNTHESIS OF IVABRADINE AND ITS SALTS OF ADDITION TO A PHARMACEUTICALLY ACCEPTABLE ACID
AU2005268972A1 (en) * 2004-08-02 2006-02-09 Chiesi Farmaceutici S.P.A. A process for the preparation of a piroxicam: beta­cyclodextrin inclusion compound
FR2882555B1 (en) 2005-02-28 2007-05-04 Servier Lab CRYSTALLINE GAMMA FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
FR2882554B1 (en) 2005-02-28 2007-05-04 Servier Lab IVABRADINE HYDROCHLORIDE BETA D-CRYSTALLINE FORM, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
FR2882556B1 (en) 2005-02-28 2007-05-04 Servier Lab CRYSTALLINE GAMMA D FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
FR2882553B1 (en) 2005-02-28 2007-05-04 Servier Lab CRYSTALLINE BETA FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
FR2891826B1 (en) 2005-10-11 2007-12-28 Servier Lab CRYSTALLINE FORM 6 OF IVABRADINE HYDROCHLORIDE, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
FR2891827B1 (en) 2005-10-11 2007-12-28 Servier Lab CRYSTALLINE DELTAD FORM OF IVABRADINE HYDROCHLORIDE, PROCESS FOR PREPARING THE SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
RU2473544C2 (en) 2007-05-30 2013-01-27 Инд-Свифт Лабораториз Лимитед Method of producing ivabradine hydrochloride and polymorphs thereof
CN101597261A (en) 2008-06-06 2009-12-09 北京深蓝海生物医药科技有限公司 Amorphous ivabradine hydrochloride
CN101463008A (en) 2009-01-11 2009-06-24 山东鲁抗辰欣药业有限公司 Ivabradine amorphous article and preparation thereof
CN101559228B (en) * 2009-06-01 2011-05-18 石药集团欧意药业有限公司 Pharmaceutical composition for treating chronic stable angina pectoris with hyperlipemia
SI2902384T1 (en) 2010-02-12 2018-03-30 Krka, D.D., Novo Mesto Form of ivabradine hydrochloride
PT2579860E (en) 2010-06-14 2014-05-30 Ratiopharm Gmbh Ivabradine-containing pharmaceutical composition with modified release
EP2589594A1 (en) 2011-11-04 2013-05-08 Urquima S.A. Ivabradine hydrochloride Form IV
WO2014161131A1 (en) * 2013-04-01 2014-10-09 Arissa Pharma PREPARING AMORPHOUS MELOXICAM-β-CYCLODEXTRIN INCLUSION COMPLEX VIA SPRAY DRYING PROCESS
CN103393611B (en) * 2013-08-06 2015-08-19 南京正大天晴制药有限公司 A kind of Ivabradine hydrochloride tablet and preparation method thereof

Also Published As

Publication number Publication date
MX363389B (en) 2019-03-20
WO2015001133A1 (en) 2015-01-08
ES2672472T3 (en) 2018-06-14

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