JP6248112B2 - アピキサバン液体製剤 - Google Patents

アピキサバン液体製剤 Download PDF

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Publication number
JP6248112B2
JP6248112B2 JP2015534679A JP2015534679A JP6248112B2 JP 6248112 B2 JP6248112 B2 JP 6248112B2 JP 2015534679 A JP2015534679 A JP 2015534679A JP 2015534679 A JP2015534679 A JP 2015534679A JP 6248112 B2 JP6248112 B2 JP 6248112B2
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JP
Japan
Prior art keywords
vehicle
liquid formulation
weight
apixaban
content
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
JP2015534679A
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English (en)
Japanese (ja)
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JP2015531377A (ja
JP2015531377A5 (cg-RX-API-DMAC7.html
Inventor
シェリフ・イブラヒム・ファラグ・バダウィ
スーザン・ラム
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.)
Bristol Myers Squibb Holdings Ireland ULC
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Bristol Myers Squibb Holdings Ireland ULC
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Publication of JP2015531377A publication Critical patent/JP2015531377A/ja
Publication of JP2015531377A5 publication Critical patent/JP2015531377A5/ja
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Expired - Fee Related legal-status Critical Current
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    • 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
    • A61K31/4353Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2015534679A 2012-09-26 2013-09-26 アピキサバン液体製剤 Expired - Fee Related JP6248112B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261705943P 2012-09-26 2012-09-26
US61/705,943 2012-09-26
US201361773032P 2013-03-05 2013-03-05
US61/773,032 2013-03-05
PCT/US2013/062051 WO2014052678A1 (en) 2012-09-26 2013-09-26 Apixaban liquid formulations

Publications (3)

Publication Number Publication Date
JP2015531377A JP2015531377A (ja) 2015-11-02
JP2015531377A5 JP2015531377A5 (cg-RX-API-DMAC7.html) 2016-11-10
JP6248112B2 true JP6248112B2 (ja) 2017-12-13

Family

ID=49447800

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015534679A Expired - Fee Related JP6248112B2 (ja) 2012-09-26 2013-09-26 アピキサバン液体製剤

Country Status (18)

Country Link
US (2) US9452134B2 (cg-RX-API-DMAC7.html)
EP (1) EP2900217A1 (cg-RX-API-DMAC7.html)
JP (1) JP6248112B2 (cg-RX-API-DMAC7.html)
KR (1) KR102035373B1 (cg-RX-API-DMAC7.html)
CN (1) CN104736142B (cg-RX-API-DMAC7.html)
AU (1) AU2013323435C1 (cg-RX-API-DMAC7.html)
BR (1) BR112015005995A2 (cg-RX-API-DMAC7.html)
CA (1) CA2885899A1 (cg-RX-API-DMAC7.html)
HK (1) HK1212900A1 (cg-RX-API-DMAC7.html)
IL (1) IL237804A0 (cg-RX-API-DMAC7.html)
IN (1) IN2015DN01902A (cg-RX-API-DMAC7.html)
MX (1) MX358097B (cg-RX-API-DMAC7.html)
MY (1) MY179191A (cg-RX-API-DMAC7.html)
NZ (1) NZ630763A (cg-RX-API-DMAC7.html)
PH (1) PH12015500590B1 (cg-RX-API-DMAC7.html)
RU (1) RU2660358C2 (cg-RX-API-DMAC7.html)
SG (2) SG11201501743UA (cg-RX-API-DMAC7.html)
WO (1) WO2014052678A1 (cg-RX-API-DMAC7.html)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2907507A1 (en) * 2014-02-17 2015-08-19 Sandoz Ag Pharmaceutical composition comprising apixaban
WO2017221209A1 (en) 2016-06-23 2017-12-28 Lupin Limited Pharmaceutical formulations of apixaban
SI3781132T1 (sl) * 2018-04-16 2024-07-31 Bristol-Myers Squibb Company Formulacije apiksabana
WO2020034989A1 (zh) 2018-08-14 2020-02-20 江苏恒瑞医药股份有限公司 一种可注射的药物组合物及其制备方法
PH12022551126A1 (en) 2019-11-13 2023-08-23 Unison Pharmaceuticals Pvt Ltd Orally disintegrating pharmaceutical compositions of apixaban
EP4259098A1 (en) 2020-12-13 2023-10-18 Dafechem Ltd Liquid apixaban formulation in small dose volume
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
NL2029536B1 (en) 2021-10-27 2023-05-26 Pharma Data S A Apixaban suspension and preparation method
US12214075B2 (en) 2021-10-27 2025-02-04 Pharma-Data Research And Development Single Member S.A. Apixaban suspension and preparation method
US12194028B2 (en) * 2022-03-09 2025-01-14 Slayback Pharma Llc Stable pharmaceutical compositions of apixaban
EP4522123A1 (en) * 2022-05-09 2025-03-19 SYRI Research Private Limited Liquid oral formulation of apixaban or pharmaceutically acceptable salt thereof
US12213972B2 (en) * 2022-07-27 2025-02-04 Slayback Pharma Llc Stable pharmaceutical compositions of apixaban
US11833138B1 (en) 2023-01-30 2023-12-05 Tap Pharmaceuticals Ag Liquid pharmaceutical formulations of apixaban
WO2024160789A1 (en) 2023-01-30 2024-08-08 Tap Pharmaceuticals Ag Liquid pharmaceutical formulations of apixaban
US20250319077A1 (en) 2023-04-14 2025-10-16 Novick BioSciences Private Limited Apixaban compositions

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5763449A (en) * 1996-08-07 1998-06-09 Ascent Pediatrics, Inc. Pleasant-tasting aqueous liquid composition of a bitter-tasting drug
KR100558239B1 (ko) 1999-12-23 2006-03-10 화이자 프로덕츠 인크. 증가된 약물 농도를 제공하는 제약학적 조성물
MY129350A (en) * 2001-04-25 2007-03-30 Bristol Myers Squibb Co Aripiprazole oral solution
EP1269994A3 (en) 2001-06-22 2003-02-12 Pfizer Products Inc. Pharmaceutical compositions comprising drug and concentration-enhancing polymers
TWI320039B (en) 2001-09-21 2010-02-01 Lactam-containing compounds and derivatives thereof as factor xa inhibitors
RS51444B (sr) * 2001-09-21 2011-04-30 Bristol-Myers Squibb Company JEDINJENJA KOJA SADRŽE LAKTAM I NJIHOVI DERIVATI KAO INHIBITORI FAKTORA Xa
US7101572B2 (en) * 2001-12-07 2006-09-05 Unilab Pharmatech, Ltd. Taste masked aqueous liquid pharmaceutical composition
CA2597155A1 (en) * 2005-02-25 2006-09-08 Biomarin Pharmaceutical Inc. Room temperature stable aqueous liquid pharmaceutical composition
US20070191306A1 (en) * 2005-08-17 2007-08-16 Bristol-Myers Squibb Company FACTOR Xa INHIBITOR FORMULATION AND METHOD
AU2009205314A1 (en) * 2008-01-14 2009-07-23 Foamix Ltd. Poloxamer foamable pharmaceutical compositions with active agents and/or therapeutic cells and uses
CA2761455C (en) * 2009-05-13 2018-06-12 Cydex Pharmaceuticals, Inc. Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same
SMT202000093T1 (it) * 2009-06-16 2020-03-13 Pfizer Forme di dosaggio di apixaban
PE20160042A1 (es) * 2010-02-25 2016-01-28 Bristol Myers Squibb Holdings Ireland Formulaciones de apixaban
EP2484775A1 (de) 2011-02-07 2012-08-08 Siemens Healthcare Diagnostics Products GmbH Heparin-insensitives Verfahren zur Bestimmung von direkten Gerinnungsfaktorinhibitoren
RU2638155C1 (ru) * 2016-02-29 2017-12-12 Общество С Ограниченной Ответственностью "Сай Фарма" Производные бензо[d]изоксазола и их применение

Also Published As

Publication number Publication date
US20150224053A1 (en) 2015-08-13
JP2015531377A (ja) 2015-11-02
RU2015115127A (ru) 2016-11-20
AU2013323435A1 (en) 2014-04-03
AU2013323435B2 (en) 2017-10-19
HK1212900A1 (zh) 2016-06-24
RU2660358C2 (ru) 2018-07-05
US9452134B2 (en) 2016-09-27
PH12015500590B1 (en) 2019-08-23
IN2015DN01902A (cg-RX-API-DMAC7.html) 2015-08-07
MX2015003393A (es) 2015-09-25
CN104736142A (zh) 2015-06-24
PH12015500590A1 (en) 2015-05-25
MY179191A (en) 2020-10-30
AU2013323435C1 (en) 2018-04-12
US20160263097A1 (en) 2016-09-15
MX358097B (es) 2018-08-06
CA2885899A1 (en) 2014-04-03
EP2900217A1 (en) 2015-08-05
CN104736142B (zh) 2020-03-03
IL237804A0 (en) 2015-05-31
KR102035373B1 (ko) 2019-10-22
AU2013323435A8 (en) 2015-04-23
KR20150058243A (ko) 2015-05-28
SG11201501743UA (en) 2015-04-29
SG10201702048VA (en) 2017-04-27
WO2014052678A1 (en) 2014-04-03
US10016362B2 (en) 2018-07-10
NZ630763A (en) 2017-01-27
BR112015005995A2 (pt) 2017-07-04

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