CA2830962C - Otamixaban formulations with improved stability - Google Patents

Otamixaban formulations with improved stability Download PDF

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Publication number
CA2830962C
CA2830962C CA2830962A CA2830962A CA2830962C CA 2830962 C CA2830962 C CA 2830962C CA 2830962 A CA2830962 A CA 2830962A CA 2830962 A CA2830962 A CA 2830962A CA 2830962 C CA2830962 C CA 2830962C
Authority
CA
Canada
Prior art keywords
acid
pharmaceutical composition
methyl
amino
aqueous pharmaceutical
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.)
Expired - Fee Related
Application number
CA2830962A
Other languages
English (en)
French (fr)
Other versions
CA2830962A1 (en
Inventor
Walter Kamm
Till BUSSEMER
Doris Andert
Bernd Kuhn
Ernst-Josef TODT
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.)
Sanofi SA
Original Assignee
Sanofi 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
Application filed by Sanofi SA filed Critical Sanofi SA
Publication of CA2830962A1 publication Critical patent/CA2830962A1/en
Application granted granted Critical
Publication of CA2830962C publication Critical patent/CA2830962C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4425Pyridinium derivatives, e.g. pralidoxime, pyridostigmine
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61P9/10Drugs 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
CA2830962A 2011-03-29 2012-03-27 Otamixaban formulations with improved stability Expired - Fee Related CA2830962C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP11305347 2011-03-29
EP11305347.4 2011-03-29
US201161499941P 2011-06-22 2011-06-22
US61/499,941 2011-06-22
PCT/EP2012/055361 WO2012130819A1 (en) 2011-03-29 2012-03-27 Otamixaban formulations with improved stability

Publications (2)

Publication Number Publication Date
CA2830962A1 CA2830962A1 (en) 2012-10-04
CA2830962C true CA2830962C (en) 2019-06-18

Family

ID=44584895

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2830962A Expired - Fee Related CA2830962C (en) 2011-03-29 2012-03-27 Otamixaban formulations with improved stability

Country Status (19)

Country Link
US (3) US20140018398A1 (enExample)
EP (1) EP2691075A1 (enExample)
JP (1) JP5993933B2 (enExample)
KR (1) KR101844623B1 (enExample)
CN (1) CN103561723B (enExample)
AR (1) AR085580A1 (enExample)
AU (1) AU2012234323A1 (enExample)
BR (1) BR112013024801A2 (enExample)
CA (1) CA2830962C (enExample)
CO (1) CO6801755A2 (enExample)
EA (1) EA025572B1 (enExample)
IL (1) IL228573A (enExample)
MA (1) MA35050B1 (enExample)
MX (1) MX342324B (enExample)
PH (1) PH12013501991A1 (enExample)
SG (1) SG193932A1 (enExample)
UY (1) UY33975A (enExample)
WO (1) WO2012130819A1 (enExample)
ZA (1) ZA201308061B (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2012234323A1 (en) 2011-03-29 2013-10-17 Sanofi Otamixaban formulations with improved stability
PL2953931T3 (pl) 2013-01-31 2017-09-29 Vertex Pharmaceuticals Incorporated Pirydonoamidy jako modulatory kanałów sodowych
DE102013212933B3 (de) * 2013-07-03 2014-11-27 Schaeffler Technologies Gmbh & Co. Kg Lageranordnung in einem Elektromotor
EP3668516B1 (en) 2017-08-16 2021-09-22 Merck Patent GmbH Stable lyophilisates comprising 5,10-methylene-(6r)-tetrahydrofolic acid and a dicarboxylic acid
CN109010273B (zh) * 2018-10-08 2021-03-19 中国药科大学 一种阿哌沙班纳米混悬剂及其制备方法
CN113384526A (zh) * 2021-08-03 2021-09-14 合肥医工医药股份有限公司 一种稳定的阿哌沙班口服溶液制剂及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3030272A (en) * 1960-05-26 1962-04-17 Abbott Lab Stable heaparin solution
CA2149150C (en) 1992-11-27 2000-08-01 David R. Carver Injectable taxol composition with improved stability
IL125163A0 (en) 1996-01-02 1999-01-26 Rhone Poulenc Rorer Pharma Substituted n-[(aminoiminomethyl or aminomethyl) phenyl] propyl amides
US6080767A (en) 1996-01-02 2000-06-27 Aventis Pharmaceuticals Products Inc. Substituted n-[(aminoiminomethyl or aminomethyl)phenyl]propyl amides
GB0108903D0 (en) * 2000-10-05 2001-05-30 Aventis Pharm Prod Inc Novel crystalline forms of a factor Xa inhibitor
US20050059719A1 (en) * 2003-09-16 2005-03-17 Badawy Sherif Ibrahim Farag Solid dosage formulation containing a Factor Xa inhibitor and method
FR2863891B1 (fr) * 2003-12-23 2006-03-24 Pf Medicament Composition pharmaceutique de vinflunine destinee a une administration parentale, procede de preparation et utilisation
AU2010277725B2 (en) * 2009-07-29 2016-08-18 Sanofi Otamixaban for treatment of elderly and renal impaired non-ST elevation myocardial infarction patients
PT2691371E (pt) 2011-03-29 2015-07-20 Sanofi Sa Sal de ácido benzóico de otamixaban
AU2012234323A1 (en) 2011-03-29 2013-10-17 Sanofi Otamixaban formulations with improved stability

Also Published As

Publication number Publication date
UY33975A (es) 2012-10-31
US20140018398A1 (en) 2014-01-16
IL228573A0 (en) 2013-12-31
BR112013024801A2 (pt) 2016-12-20
EA025572B1 (ru) 2017-01-30
JP2014509621A (ja) 2014-04-21
US20120252852A1 (en) 2012-10-04
AU2012234323A1 (en) 2013-10-17
CN103561723A (zh) 2014-02-05
AR085580A1 (es) 2013-10-09
JP5993933B2 (ja) 2016-09-14
NZ616180A (en) 2015-10-30
US9993464B2 (en) 2018-06-12
EP2691075A1 (en) 2014-02-05
EA201391406A1 (ru) 2014-02-28
WO2012130819A1 (en) 2012-10-04
MA35050B1 (fr) 2014-04-03
MX2013011260A (es) 2014-03-27
US20170224668A1 (en) 2017-08-10
KR20140019818A (ko) 2014-02-17
PH12013501991A1 (en) 2013-11-25
IL228573A (en) 2017-12-31
CA2830962A1 (en) 2012-10-04
CO6801755A2 (es) 2013-11-29
KR101844623B1 (ko) 2018-04-02
MX342324B (es) 2016-09-23
CN103561723B (zh) 2016-04-20
ZA201308061B (en) 2015-01-28
SG193932A1 (en) 2013-11-29

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Effective date: 20170227

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