US20130084335A1 - Ivabradine-containing pharmaceutical composition - Google Patents

Ivabradine-containing pharmaceutical composition Download PDF

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Publication number
US20130084335A1
US20130084335A1 US13/704,521 US201113704521A US2013084335A1 US 20130084335 A1 US20130084335 A1 US 20130084335A1 US 201113704521 A US201113704521 A US 201113704521A US 2013084335 A1 US2013084335 A1 US 2013084335A1
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US
United States
Prior art keywords
pharmaceutical composition
composition according
active substance
ivabradine
particle size
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.)
Abandoned
Application number
US13/704,521
Other languages
English (en)
Inventor
Dominique Meergans
Katrin Rimkus
Jens Geier
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.)
Ratiopharm GmbH
Original Assignee
Ratiopharm GmbH
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 Ratiopharm GmbH filed Critical Ratiopharm GmbH
Assigned to RATIOPHARM GMBH reassignment RATIOPHARM GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GEIER, JENS, MEERGANS, DOMINIQUE, RIMKUS, KATRIN
Publication of US20130084335A1 publication Critical patent/US20130084335A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—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
    • A61K9/20—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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00—Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02—Dicarboxylic acids
    • C07C55/14—Adipic acid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D223/00—Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom
    • C07D223/14—Heterocyclic compounds containing seven-membered rings having one nitrogen atom as the only ring hetero atom condensed with carbocyclic rings or ring systems
    • C07D223/16—Benzazepines; Hydrogenated benzazepines
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
US13/704,521 2010-06-14 2011-06-14 Ivabradine-containing pharmaceutical composition Abandoned US20130084335A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP10165884.7 2010-06-14
EP10165881.3 2010-06-14
EP10165881 2010-06-14
EP10165884 2010-06-14
IN1760CH2010 2010-06-23
IN1760/CHE/2010 2010-06-23
PCT/EP2011/059865 WO2011157721A2 (fr) 2010-06-14 2011-06-14 Composition pharmaceutique contenant de l'ivabradine

Publications (1)

Publication Number Publication Date
US20130084335A1 true US20130084335A1 (en) 2013-04-04

Family

ID=44524908

Family Applications (5)

Application Number Title Priority Date Filing Date
US13/704,521 Abandoned US20130084335A1 (en) 2010-06-14 2011-06-14 Ivabradine-containing pharmaceutical composition
US13/704,580 Expired - Fee Related US8900605B2 (en) 2010-06-14 2011-06-14 Solid ivabradine-containing composition
US13/704,459 Abandoned US20130116239A1 (en) 2010-06-14 2011-06-14 Ivabradine-containing pharmaceutical composition with modified release
US14/463,296 Abandoned US20140357860A1 (en) 2010-06-14 2014-08-19 Salt of ivabradine with adipic acid
US14/517,015 Active US9339550B2 (en) 2010-06-14 2014-10-17 Solid ivabradine-containing composition

Family Applications After (4)

Application Number Title Priority Date Filing Date
US13/704,580 Expired - Fee Related US8900605B2 (en) 2010-06-14 2011-06-14 Solid ivabradine-containing composition
US13/704,459 Abandoned US20130116239A1 (en) 2010-06-14 2011-06-14 Ivabradine-containing pharmaceutical composition with modified release
US14/463,296 Abandoned US20140357860A1 (en) 2010-06-14 2014-08-19 Salt of ivabradine with adipic acid
US14/517,015 Active US9339550B2 (en) 2010-06-14 2014-10-17 Solid ivabradine-containing composition

Country Status (7)

Country Link
US (5) US20130084335A1 (fr)
EP (4) EP2946772A1 (fr)
CA (3) CA2800442C (fr)
ES (3) ES2465596T3 (fr)
PL (1) PL2579859T3 (fr)
PT (2) PT2579860E (fr)
WO (3) WO2011157722A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3025705A1 (fr) * 2014-11-25 2016-06-01 Zentiva Saglik Ürünleri Sanayi Ve Ticaret A.S. Formulations d'ivabradine stable
WO2016162437A1 (fr) * 2015-04-10 2016-10-13 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Composition pharmaceutique comprenant de l'oxalate d'ivabradine

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Publication number Priority date Publication date Assignee Title
CN102908327B (zh) * 2011-08-05 2015-03-11 江苏恒瑞医药股份有限公司 伊伐布雷定或其可药用盐的缓释制剂
WO2014114341A1 (fr) 2013-01-24 2014-07-31 Synthon Bv Procédé de préparation d'ivabradine
WO2015001569A1 (fr) * 2013-07-02 2015-01-08 Genepharm India Private Limited Composition pharmaceutique solide d'ivabradine à administrer par voie orale
CZ2013767A3 (cs) * 2013-10-02 2015-04-29 Zentiva, K.S. Pevná forma Ivabradin hydrochloridu a (S)-mandlové kyseliny a její farmaceutická kompozice
EP3073996A1 (fr) * 2013-11-28 2016-10-05 Synthon Biopharmaceuticals B.V. Composition pharmaceutique comprenant de l'ivabradine amorphe
WO2015001133A1 (fr) 2013-12-12 2015-01-08 Synthon B.V. Composition pharmaceutique comprenant de l'ivabradine amorphe
WO2015145234A1 (fr) * 2014-03-27 2015-10-01 Laboratorio Chimico Internazionale S.P.A. Adsorbats d'ivabradine
FR3020810B1 (fr) * 2014-05-06 2016-05-06 Servier Lab Nouveau sel de l'ivabradine et son procede de preparation.
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
TR201720672A2 (tr) * 2017-12-18 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi İvabradi̇ni̇n kontrollü salimli farmasöti̇k kompozi̇syonlari
CN112206234B (zh) * 2019-07-12 2021-08-24 鲁南制药集团股份有限公司 一种伊伐布雷定制剂及其制备方法

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US20070122474A1 (en) * 2000-12-07 2007-05-31 Altana Pharma Ag Pharmaceutical preparation comprising an active dispersed on a matrix

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AT413647B (de) 1998-11-26 2006-04-15 Sandoz Ag Verwendung eines copolymerisats aus 1-vinyl-2-pyrrolidon und vinylacetat zur herstellung von cefuroximaxetil-hältigen tabletten
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3025705A1 (fr) * 2014-11-25 2016-06-01 Zentiva Saglik Ürünleri Sanayi Ve Ticaret A.S. Formulations d'ivabradine stable
EP3025705B1 (fr) 2014-11-25 2018-10-24 Zentiva Saglik Ürünleri Sanayi Ve Ticaret A.S. Formulations d'ivabradine stable
WO2016162437A1 (fr) * 2015-04-10 2016-10-13 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Composition pharmaceutique comprenant de l'oxalate d'ivabradine

Also Published As

Publication number Publication date
EP2579859B1 (fr) 2015-08-05
CA2800446A1 (fr) 2011-12-22
WO2011157722A3 (fr) 2012-06-07
PT2579858E (pt) 2014-07-18
PL2579859T3 (pl) 2015-12-31
EP2946772A1 (fr) 2015-11-25
US20130116239A1 (en) 2013-05-09
PT2579860E (pt) 2014-05-30
CA2800442C (fr) 2018-05-22
WO2011157721A3 (fr) 2012-06-07
EP2579859A2 (fr) 2013-04-17
CA2800444A1 (fr) 2011-12-22
EP2579858B1 (fr) 2014-05-21
ES2478915T3 (es) 2014-07-23
US8900605B2 (en) 2014-12-02
CA2800442A1 (fr) 2011-12-22
EP2579858A2 (fr) 2013-04-17
CA2800446C (fr) 2017-12-12
US9339550B2 (en) 2016-05-17
EP2579860B1 (fr) 2014-04-23
ES2549037T3 (es) 2015-10-22
US20130158008A1 (en) 2013-06-20
US20150038491A1 (en) 2015-02-05
ES2465596T3 (es) 2014-06-06
WO2011157720A2 (fr) 2011-12-22
WO2011157721A2 (fr) 2011-12-22
EP2579860A2 (fr) 2013-04-17
WO2011157722A2 (fr) 2011-12-22
US20140357860A1 (en) 2014-12-04
WO2011157720A3 (fr) 2012-09-07
CA2800444C (fr) 2018-03-20

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