BR112014010767A2 - Forma iv do cloridrato de ivabradina - Google Patents

Forma iv do cloridrato de ivabradina

Info

Publication number
BR112014010767A2
BR112014010767A2 BR112014010767A BR112014010767A BR112014010767A2 BR 112014010767 A2 BR112014010767 A2 BR 112014010767A2 BR 112014010767 A BR112014010767 A BR 112014010767A BR 112014010767 A BR112014010767 A BR 112014010767A BR 112014010767 A2 BR112014010767 A2 BR 112014010767A2
Authority
BR
Brazil
Prior art keywords
chloridate
ivabradine
ivabradine chloridate
chloridate form
Prior art date
Application number
BR112014010767A
Other languages
English (en)
Other versions
BR112014010767B1 (pt
Inventor
Prohens Lopez Rafael
Original Assignee
Urquima 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=46934559&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112014010767(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Urquima Sa filed Critical Urquima Sa
Publication of BR112014010767A2 publication Critical patent/BR112014010767A2/pt
Publication of BR112014010767B1 publication Critical patent/BR112014010767B1/pt

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D223/00Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom
    • C07D223/14Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom condensed with carbocyclic rings or ring systems
    • C07D223/16Benzazepines; Hydrogenated benzazepines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/06Antiarrhythmics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Other In-Based Heterocyclic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
BR112014010767-0A 2011-11-04 2012-09-21 forma iv do cloridrato de ivabradina BR112014010767B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11382339.7A EP2589594A1 (en) 2011-11-04 2011-11-04 Ivabradine hydrochloride Form IV
EP11382339.7 2011-11-04
PCT/EP2012/068615 WO2013064307A1 (en) 2011-11-04 2012-09-21 Ivabradine hydrochloride form iv

Publications (2)

Publication Number Publication Date
BR112014010767A2 true BR112014010767A2 (pt) 2017-06-13
BR112014010767B1 BR112014010767B1 (pt) 2021-03-09

Family

ID=46934559

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014010767-0A BR112014010767B1 (pt) 2011-11-04 2012-09-21 forma iv do cloridrato de ivabradina

Country Status (21)

Country Link
US (3) US9139531B2 (pt)
EP (3) EP2589594A1 (pt)
JP (3) JP6359971B2 (pt)
KR (1) KR102050117B1 (pt)
AU (1) AU2012331395B2 (pt)
BR (1) BR112014010767B1 (pt)
CA (1) CA2854549C (pt)
CY (1) CY1119798T1 (pt)
DK (1) DK2773620T3 (pt)
ES (1) ES2562843T3 (pt)
HR (1) HRP20171511T1 (pt)
HU (1) HUE034996T2 (pt)
LT (1) LT2773620T (pt)
MX (1) MX359288B (pt)
PL (1) PL2773620T3 (pt)
PT (1) PT2773620T (pt)
RS (1) RS56464B1 (pt)
RU (1) RU2619121C2 (pt)
SI (1) SI2773620T1 (pt)
WO (1) WO2013064307A1 (pt)
ZA (1) ZA201403073B (pt)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2589594A1 (en) * 2011-11-04 2013-05-08 Urquima S.A. Ivabradine hydrochloride Form IV
EP3156399A1 (en) * 2011-11-14 2017-04-19 Cadila Healthcare Limited Polymorphic forms of ivabradine hydrochloride
ITMI20130684A1 (it) * 2013-04-24 2014-10-25 Chemo Res S L Nuovo polimorfo del cloridrato di ivabradina e metodo per la sua preparazione
HRP20200300T4 (hr) 2013-03-19 2023-09-15 Chemo Research, S.L. Novi polimorf ivabradin hidroklorida i metoda za njegovu pripremu
CZ305096B6 (cs) 2013-10-02 2015-04-29 Zentiva, K.S. Pevná forma Ivabradin hydrochloridu a (S)-mandlové kyseliny a její farmaceutická kompozice
MX363389B (es) 2013-12-12 2019-03-20 Synthon Bv Composicion farmaceutica que comprende ivabradina amorfa.
EP2774606B1 (en) 2014-02-14 2019-01-30 Synthon B.V. Pharmaceutical composition comprising ivabradine hydrochloride polymorph IV
CZ305436B6 (cs) 2014-07-10 2015-09-16 Zentiva, K.S. Pevná forma Ivabradin hydrochloridu a (R)-mandlové kyseliny a její farmaceutická kompozice
GR1008821B (el) 2015-06-11 2016-08-01 Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων Φαρμακευτικο σκευασμα που περιλαμβανει υδροχλωρικη ιβαμπραδινη και μεθοδος παρασκευης αυτου
TR201703066A2 (tr) 2017-02-28 2018-09-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi İvabradi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari
EP3366282A1 (en) 2017-02-28 2018-08-29 Sanovel Ilac Sanayi ve Ticaret A.S. Solid oral pharmaceutical compositions of ivabradine
US11294199B2 (en) 2017-09-19 2022-04-05 Mitsui Chemicals, Inc. Eyewear
US20230181472A1 (en) * 2018-10-30 2023-06-15 Amgen Inc. Process of making ivabradine hydrochloride drug product
IT202000025312A1 (it) 2020-10-26 2022-04-26 Cambrex Profarmaco Milano S R L Processi per la preparazione di polimorfi di ivabradina hcl

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2681862B1 (fr) * 1991-09-27 1993-11-12 Adir Cie Nouvelles (benzocycloalkyl)alkylamines, leur procede de preparation, et les compositions pharmaceutiques qui les contiennent.
FR2868777B1 (fr) 2004-04-13 2006-05-26 Servier Lab Nouveau procede de synthese de l'ivabradine et de ses sels d'addition a un acide pharmaceutiquement acceptable
FR2882554B1 (fr) * 2005-02-28 2007-05-04 Servier Lab Forme critalline beta d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
FR2882555B1 (fr) 2005-02-28 2007-05-04 Servier Lab Forme cristalline gamma du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
FR2882553B1 (fr) 2005-02-28 2007-05-04 Servier Lab Forme cristalline beta du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
FR2882556B1 (fr) 2005-02-28 2007-05-04 Servier Lab Forme cristalline gamma d du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
FR2891827B1 (fr) * 2005-10-11 2007-12-28 Servier Lab Forme cristalline deltad du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
FR2891826B1 (fr) 2005-10-11 2007-12-28 Servier Lab Forme cristalline 6 du chlorhydrate de l'ivabradine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
ATE544754T1 (de) * 2006-11-30 2012-02-15 Cadila Healthcare Ltd Verfahren zur herstellung von ivabradinhydrochlorid
WO2008125006A1 (fr) * 2007-04-12 2008-10-23 Utopharm (Shanghai) Co., Ltd Procédés de préparation du chlorhydrate d'ivabradine et de sa forme cristalline stable
WO2008146308A2 (en) 2007-05-30 2008-12-04 Ind-Swift Laboratories Limited Process for the preparation of ivabradine hydrochloride and polymorph thereof
CN101597261A (zh) 2008-06-06 2009-12-09 北京深蓝海生物医药科技有限公司 无定形盐酸伊伐布雷定
US20100323471A1 (en) 2008-08-21 2010-12-23 Applied Materials, Inc. Selective Etch of Laser Scribed Solar Cell Substrate
CN101768117B (zh) 2008-12-29 2014-05-07 北京德众万全药物技术开发有限公司 一种盐酸伊伐布雷定晶型及其制备方法
CN101463008A (zh) 2009-01-11 2009-06-24 山东鲁抗辰欣药业有限公司 盐酸伊伐布雷定无定型物及其制备方法
CN101805289A (zh) 2009-02-17 2010-08-18 成都威克药业有限责任公司 伊伐布雷定盐酸盐的ω-晶型、其制备方法和药物组合物
CN102050784B (zh) 2009-11-04 2014-07-09 扬子江药业集团北京海燕药业有限公司 一种无定型盐酸伊伐布雷定的制备方法
SI23290A (sl) 2010-02-12 2011-08-31 Krka D.D., Novo Mesto Nove oblike ivabradin hidroklorida
WO2012025940A1 (en) 2010-08-25 2012-03-01 Cadila Healthcare Limited Polymorphic form of ivabradine hydrochloride and process for preparation thereof
EP2589594A1 (en) * 2011-11-04 2013-05-08 Urquima S.A. Ivabradine hydrochloride Form IV
EP3156399A1 (en) * 2011-11-14 2017-04-19 Cadila Healthcare Limited Polymorphic forms of ivabradine hydrochloride

Also Published As

Publication number Publication date
US20140315890A1 (en) 2014-10-23
KR20140101753A (ko) 2014-08-20
WO2013064307A1 (en) 2013-05-10
EP2773620A1 (en) 2014-09-10
PT2773620T (pt) 2017-10-19
RS56464B1 (sr) 2018-01-31
SI2773620T1 (sl) 2017-11-30
EP2773620B1 (en) 2017-08-16
HRP20171511T1 (hr) 2017-11-17
CA2854549C (en) 2019-08-27
EP2589594A1 (en) 2013-05-08
ES2562843T3 (es) 2017-10-19
MX2014005362A (es) 2015-01-22
BR112014010767B1 (pt) 2021-03-09
PL2773620T3 (pl) 2017-12-29
KR102050117B1 (ko) 2020-01-08
EP3263556A1 (en) 2018-01-03
DK2773620T3 (en) 2017-10-09
HUE034996T2 (en) 2018-05-02
CA2854549A1 (en) 2013-05-10
JP2018123154A (ja) 2018-08-09
US20150344435A1 (en) 2015-12-03
US20160289192A1 (en) 2016-10-06
LT2773620T (lt) 2017-10-25
CY1119798T1 (el) 2018-06-27
JP6359971B2 (ja) 2018-07-18
RU2014122261A (ru) 2015-12-10
AU2012331395B2 (en) 2016-11-17
JP2014532673A (ja) 2014-12-08
MX359288B (es) 2018-09-20
ES2562843T1 (es) 2016-03-08
US9309201B2 (en) 2016-04-12
JP2017178965A (ja) 2017-10-05
AU2012331395A1 (en) 2014-05-22
ZA201403073B (en) 2015-03-25
US9139531B2 (en) 2015-09-22
RU2619121C2 (ru) 2017-05-12

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B06F Objections, documents and/or translations needed after an examination request according art. 34 industrial property law
B07E Notice of approval relating to section 229 industrial property law
B06U Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure
B09A Decision: intention to grant
B09X Decision of grant: republication
B16A Patent or certificate of addition of invention granted

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/09/2012, OBSERVADAS AS CONDICOES LEGAIS.