WO2015124995A1 - Formes galéniques solides de rivaroxaban - Google Patents

Formes galéniques solides de rivaroxaban Download PDF

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Publication number
WO2015124995A1
WO2015124995A1 PCT/IB2015/000196 IB2015000196W WO2015124995A1 WO 2015124995 A1 WO2015124995 A1 WO 2015124995A1 IB 2015000196 W IB2015000196 W IB 2015000196W WO 2015124995 A1 WO2015124995 A1 WO 2015124995A1
Authority
WO
WIPO (PCT)
Prior art keywords
rivaroxaban
dosage form
solution
granules
iii
Prior art date
Application number
PCT/IB2015/000196
Other languages
English (en)
Inventor
Saravanan Kannusamy
Venkata Vijaya Narasimha Kishan JAYANTHY
Taqiuddin Aman MOHAMMED
Jayant KARAJGI
Sivakumaran Meenakshisunderam
Original Assignee
Aurobindo Pharma Ltd
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 Aurobindo Pharma Ltd filed Critical Aurobindo Pharma Ltd
Publication of WO2015124995A1 publication Critical patent/WO2015124995A1/fr

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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
    • A61K9/2022—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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

L'invention concerne un procédé de préparation de forme galénique solide de composé dérivé d'oxazolidinone. L'invention concerne plus particulièrement un procédé de préparation de forme galénique solide de rivaroxaban.
PCT/IB2015/000196 2014-02-19 2015-02-17 Formes galéniques solides de rivaroxaban WO2015124995A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN785CH2014 2014-02-19
IN785/CHE/2014 2014-02-19

Publications (1)

Publication Number Publication Date
WO2015124995A1 true WO2015124995A1 (fr) 2015-08-27

Family

ID=52808074

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2015/000196 WO2015124995A1 (fr) 2014-02-19 2015-02-17 Formes galéniques solides de rivaroxaban

Country Status (1)

Country Link
WO (1) WO2015124995A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105267169A (zh) * 2015-12-07 2016-01-27 石家庄康贺威药业有限公司 一种利伐沙班片剂及其制备方法
WO2017146709A1 (fr) * 2016-02-25 2017-08-31 Mylan Inc. Procédé unique de granulation sous fort cisaillement améliorant la biodisponibilité du rivaroxaban
CN109157517A (zh) * 2018-10-15 2019-01-08 吉林省中晟制药有限公司 一种利伐沙班颗粒剂及制备方法
GR1009619B (el) * 2018-05-09 2019-10-23 Φαρμαζακ Α.Φ.Ε.Β.Ε. Φαρμακευτικη συνθεση που περιεχει ριβαροξαβανη και μεθοδος για την παρασκευη αυτης
CN112451531A (zh) * 2020-12-09 2021-03-09 乐普药业股份有限公司 一种阿司匹林和利伐沙班复方制剂及其制备方法
US20210267908A1 (en) * 2020-03-02 2021-09-02 Mankind Pharma Ltd. Pharmaceutical compositions of rivaroxaban
CN113425729A (zh) * 2021-06-24 2021-09-24 上海奥全生物医药科技有限公司 一种含有利伐沙班的药物组合物及其应用
WO2022049602A1 (fr) * 2020-09-05 2022-03-10 Inventia Healthcare Limited Compositions de rivaroxaban
CN114767647A (zh) * 2022-03-22 2022-07-22 新发药业有限公司 一种利伐沙班口服固体制剂的制备方法
CN114886867A (zh) * 2022-06-16 2022-08-12 北京四环制药有限公司 一种高稳定性的利伐沙班药物组合物及其制备方法
WO2022259118A1 (fr) * 2021-06-10 2022-12-15 Shilpa Medicare Limited Préparation de film oral à dissolution rapide comprenant du rivaroxaban

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7157456B2 (en) 1999-12-24 2007-01-02 Bayer Healthcare Ag Substituted oxazolidinones and their use in the field of blood coagulation
US20070026065A1 (en) * 2004-12-24 2007-02-01 Bayer Healthcare Ag Solid, modified-release pharmaceutical dosage forms which can be administered orally
US20080026057A1 (en) 2003-11-27 2008-01-31 Bayer Healthcare Ag Process for the Preparation of a Solid, Orally Administrable Pharmaceutical Composition
US7767702B2 (en) 2001-06-20 2010-08-03 Bayer Schering Pharma Aktiengesellschaft Substituted oxazolidinones for combinational therapy
WO2010146179A2 (fr) 2009-06-18 2010-12-23 Krka, Tovarna Zdravil, D.D., Novo Mesto Composition pharmaceutique solide comprenant du rivaroxaban
US20110189279A1 (en) 2008-08-11 2011-08-04 Ratiopharm Gmbh Pharmaceutical compositions with modified release properties comprising 5-chloro-n-(-methyl)-2-thiophencarboxamid
US20120231076A1 (en) 2009-10-06 2012-09-13 Ratiopharm Gmbh Pharmaceutical compositions comprising rivaroxaban
US20130064888A1 (en) 2011-08-08 2013-03-14 Roey Solomonovich Pharmaceutical formulations
US20130281457A1 (en) 2008-07-08 2013-10-24 Ratiopharm Gmbh Pharmaceutical compositions comprising 5-chloro-n-(-methyl)-2-thiophencarboxamid
US8586082B2 (en) 2005-10-04 2013-11-19 Bayer Intellectual Property Gmbh Solid orally administerable pharmaceutical dosage forms with rapid active principle release

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7157456B2 (en) 1999-12-24 2007-01-02 Bayer Healthcare Ag Substituted oxazolidinones and their use in the field of blood coagulation
US7585860B2 (en) 1999-12-24 2009-09-08 Bayer Schering Pharma Aktiengesellschaft Substituted oxazolidinones and their use in the field of blood coagulation
US7592339B2 (en) 1999-12-24 2009-09-22 Bayer Schering Pharma Aktiengesellschaft Substituted oxazolidinones and their use in the field of blood coagulation
US7767702B2 (en) 2001-06-20 2010-08-03 Bayer Schering Pharma Aktiengesellschaft Substituted oxazolidinones for combinational therapy
US20080026057A1 (en) 2003-11-27 2008-01-31 Bayer Healthcare Ag Process for the Preparation of a Solid, Orally Administrable Pharmaceutical Composition
US20070026065A1 (en) * 2004-12-24 2007-02-01 Bayer Healthcare Ag Solid, modified-release pharmaceutical dosage forms which can be administered orally
US8586082B2 (en) 2005-10-04 2013-11-19 Bayer Intellectual Property Gmbh Solid orally administerable pharmaceutical dosage forms with rapid active principle release
US20130281457A1 (en) 2008-07-08 2013-10-24 Ratiopharm Gmbh Pharmaceutical compositions comprising 5-chloro-n-(-methyl)-2-thiophencarboxamid
US20110189279A1 (en) 2008-08-11 2011-08-04 Ratiopharm Gmbh Pharmaceutical compositions with modified release properties comprising 5-chloro-n-(-methyl)-2-thiophencarboxamid
WO2010146179A2 (fr) 2009-06-18 2010-12-23 Krka, Tovarna Zdravil, D.D., Novo Mesto Composition pharmaceutique solide comprenant du rivaroxaban
US20120231076A1 (en) 2009-10-06 2012-09-13 Ratiopharm Gmbh Pharmaceutical compositions comprising rivaroxaban
US20130064888A1 (en) 2011-08-08 2013-03-14 Roey Solomonovich Pharmaceutical formulations

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105267169A (zh) * 2015-12-07 2016-01-27 石家庄康贺威药业有限公司 一种利伐沙班片剂及其制备方法
WO2017146709A1 (fr) * 2016-02-25 2017-08-31 Mylan Inc. Procédé unique de granulation sous fort cisaillement améliorant la biodisponibilité du rivaroxaban
GR1009619B (el) * 2018-05-09 2019-10-23 Φαρμαζακ Α.Φ.Ε.Β.Ε. Φαρμακευτικη συνθεση που περιεχει ριβαροξαβανη και μεθοδος για την παρασκευη αυτης
CN109157517A (zh) * 2018-10-15 2019-01-08 吉林省中晟制药有限公司 一种利伐沙班颗粒剂及制备方法
US20210267908A1 (en) * 2020-03-02 2021-09-02 Mankind Pharma Ltd. Pharmaceutical compositions of rivaroxaban
WO2022049602A1 (fr) * 2020-09-05 2022-03-10 Inventia Healthcare Limited Compositions de rivaroxaban
CN112451531A (zh) * 2020-12-09 2021-03-09 乐普药业股份有限公司 一种阿司匹林和利伐沙班复方制剂及其制备方法
WO2022259118A1 (fr) * 2021-06-10 2022-12-15 Shilpa Medicare Limited Préparation de film oral à dissolution rapide comprenant du rivaroxaban
CN113425729A (zh) * 2021-06-24 2021-09-24 上海奥全生物医药科技有限公司 一种含有利伐沙班的药物组合物及其应用
CN114767647A (zh) * 2022-03-22 2022-07-22 新发药业有限公司 一种利伐沙班口服固体制剂的制备方法
CN114767647B (zh) * 2022-03-22 2024-04-16 新发药业有限公司 一种利伐沙班口服固体制剂的制备方法
CN114886867A (zh) * 2022-06-16 2022-08-12 北京四环制药有限公司 一种高稳定性的利伐沙班药物组合物及其制备方法

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