GR1008821B - Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof - Google Patents

Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof

Info

Publication number
GR1008821B
GR1008821B GR20150100270A GR20150100270A GR1008821B GR 1008821 B GR1008821 B GR 1008821B GR 20150100270 A GR20150100270 A GR 20150100270A GR 20150100270 A GR20150100270 A GR 20150100270A GR 1008821 B GR1008821 B GR 1008821B
Authority
GR
Greece
Prior art keywords
preparation
pharmaceutical composition
ivabradine hydrochloride
relates
excipients
Prior art date
Application number
GR20150100270A
Other languages
Greek (el)
Inventor
Ευθυμιος Χρηστου Κουτρης
Ιωαννα Χρηστου Κουτρη
Αναστασια Λεωνιδα Καλασκανη
Βασιλικη Χρηστου Σαμαρα
Μορφης Νικολαου Αμπατζης
Ευαγγελος Ανδρεα Καραβας
Χριστινα-Χρυση Ηλια Κιζιριδη
Original Assignee
Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων
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 Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων filed Critical Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων
Priority to GR20150100270A priority Critical patent/GR1008821B/en
Priority to PCT/EP2016/000928 priority patent/WO2016198154A1/en
Priority to EP16733287.3A priority patent/EP3307249A1/en
Publication of GR1008821B publication Critical patent/GR1008821B/en

Links

Classifications

    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K47/02—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—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
    • A61K9/20—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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A61K9/2036—Silicones; Polysiloxanes
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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

Abstract

The present invention relates to a stable pharmaceutical formulation of solid dosage forms for oral administration containing a therapeutically effective amount of Ivabradine HCl polymorph IV or δ in combination with moisture protective excipients and/or low or non-hygroscopic anhydrous excipients in order to avoid polymorphic transformation of the active ingredient. It also relates to a process for the preparation thereof.
GR20150100270A 2015-06-11 2015-06-11 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof GR1008821B (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
GR20150100270A GR1008821B (en) 2015-06-11 2015-06-11 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof
PCT/EP2016/000928 WO2016198154A1 (en) 2015-06-11 2016-06-06 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof
EP16733287.3A EP3307249A1 (en) 2015-06-11 2016-06-06 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GR20150100270A GR1008821B (en) 2015-06-11 2015-06-11 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof

Publications (1)

Publication Number Publication Date
GR1008821B true GR1008821B (en) 2016-08-01

Family

ID=56292652

Family Applications (1)

Application Number Title Priority Date Filing Date
GR20150100270A GR1008821B (en) 2015-06-11 2015-06-11 Pharmaceutical composition comprising ivabradine hydrochloride and method for preparation thereof

Country Status (3)

Country Link
EP (1) EP3307249A1 (en)
GR (1) GR1008821B (en)
WO (1) WO2016198154A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112206235B (en) * 2019-07-12 2021-09-14 鲁南制药集团股份有限公司 Ivabradine hydrochloride tablet and preparation method thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2834896B1 (en) 2002-01-23 2004-02-27 Servier Lab ORODISPERSIBLE PHARMACEUTICAL COMPOSITION OF IVABRADINE
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
CA2800442C (en) 2010-06-14 2018-05-22 Ratiopharm Gmbh Ivabradine-containing pharmaceutical composition with modified release
EP2589594A1 (en) 2011-11-04 2013-05-08 Urquima S.A. Ivabradine hydrochloride Form IV
ES2717715T3 (en) * 2014-02-14 2019-06-24 Synthon Bv Pharmaceutical composition comprising polymorph IV of ivabradine hydrochloride

Also Published As

Publication number Publication date
WO2016198154A1 (en) 2016-12-15
EP3307249A1 (en) 2018-04-18

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Legal Events

Date Code Title Description
PG Patent granted

Effective date: 20160921