KR102035373B1 - 아픽사반 액체 제제 - Google Patents

아픽사반 액체 제제 Download PDF

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Publication number
KR102035373B1
KR102035373B1 KR1020157007276A KR20157007276A KR102035373B1 KR 102035373 B1 KR102035373 B1 KR 102035373B1 KR 1020157007276 A KR1020157007276 A KR 1020157007276A KR 20157007276 A KR20157007276 A KR 20157007276A KR 102035373 B1 KR102035373 B1 KR 102035373B1
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vehicle
delete delete
apixaban
content
liquid formulation
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Expired - Fee Related
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English (en)
Korean (ko)
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KR20150058243A (ko
Inventor
쉐리프 이브라힘 파라그 바다위
수잔 룸
Original Assignee
브리스톨-마이어스 스퀴브 홀딩스 아일랜드 언리미티드 컴퍼니
화이자 인코포레이티드
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    • 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
    • A61K9/08—Solutions
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/4353—Heterocyclic 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
    • A61K31/437—Heterocyclic 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
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non 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
    • 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
    • A61K47/06—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/20—Organic 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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

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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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020157007276A 2012-09-26 2013-09-26 아픽사반 액체 제제 Expired - Fee Related KR102035373B1 (ko)

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 (2)

Publication Number Publication Date
KR20150058243A KR20150058243A (ko) 2015-05-28
KR102035373B1 true KR102035373B1 (ko) 2019-10-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020157007276A Expired - Fee Related KR102035373B1 (ko) 2012-09-26 2013-09-26 아픽사반 액체 제제

Country Status (18)

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

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
PT3781132T (pt) * 2018-04-16 2024-05-16 Pfizer Formulações de apixabano
BR112021002675A2 (pt) 2018-08-14 2021-05-11 Jiangsu Hengrui Medicine Co., Ltd. composições farmacêuticas, métodos para preparar as referidas composições e uso das mesmas
HUE073416T2 (hu) 2019-11-13 2026-01-28 Unison Pharmaceuticals Pvt Ltd Az apixaban orálisan dezintegrálódó gyógyszerkészítményei
WO2022123074A1 (en) 2020-12-13 2022-06-16 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
WO2023218482A1 (en) 2022-05-09 2023-11-16 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
EP4658238A1 (en) * 2023-01-30 2025-12-10 TAP Pharmaceuticals AG Liquid pharmaceutical formulations of apixaban
US11833138B1 (en) 2023-01-30 2023-12-05 Tap Pharmaceuticals Ag Liquid pharmaceutical formulations of apixaban
EP4450064A1 (en) 2023-04-14 2024-10-23 Novick BioSciences Private Limited Apixaban compositions

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120202232A1 (en) 2011-02-07 2012-08-09 Siemens Healthcare Diagnostics Products Gmbh Heparin-insensitive Method for Determining Direct Coagulation Factor Inhibitors

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US5763449A (en) * 1996-08-07 1998-06-09 Ascent Pediatrics, Inc. Pleasant-tasting aqueous liquid composition of a bitter-tasting drug
GEP20053427B (en) 1999-12-23 2005-01-25 Pfizer Prod Inc Pharmaceutical Compositions Providing Enhanced Drug Concentrations
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
TWI331526B (en) 2001-09-21 2010-10-11 Bristol Myers Squibb Pharma Co Lactam-containing compounds and derivatives thereof as factor xa inhibitors
CA2461202C (en) * 2001-09-21 2011-07-12 Donald Pinto Lactam-containing compounds and derivatives thereof as factor xa inhibitors
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US20070191306A1 (en) * 2005-08-17 2007-08-16 Bristol-Myers Squibb Company FACTOR Xa INHIBITOR FORMULATION AND METHOD
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SMT202000093T1 (it) * 2009-06-16 2020-03-13 Pfizer Forme di dosaggio di apixaban
IN2012DN06587A (https=) * 2010-02-25 2015-10-23 Bristol Myers Squibb Co
RU2638155C1 (ru) * 2016-02-29 2017-12-12 Общество С Ограниченной Ответственностью "Сай Фарма" Производные бензо[d]изоксазола и их применение

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US20120202232A1 (en) 2011-02-07 2012-08-09 Siemens Healthcare Diagnostics Products Gmbh Heparin-insensitive Method for Determining Direct Coagulation Factor Inhibitors

Also Published As

Publication number Publication date
CN104736142B (zh) 2020-03-03
IN2015DN01902A (https=) 2015-08-07
IL237804A0 (en) 2015-05-31
PH12015500590A1 (en) 2015-05-25
JP6248112B2 (ja) 2017-12-13
AU2013323435C1 (en) 2018-04-12
CA2885899A1 (en) 2014-04-03
KR20150058243A (ko) 2015-05-28
US20160263097A1 (en) 2016-09-15
PH12015500590B1 (en) 2019-08-23
MY179191A (en) 2020-10-30
AU2013323435A8 (en) 2015-04-23
RU2015115127A (ru) 2016-11-20
NZ630763A (en) 2017-01-27
US10016362B2 (en) 2018-07-10
SG10201702048VA (en) 2017-04-27
CN104736142A (zh) 2015-06-24
US20150224053A1 (en) 2015-08-13
AU2013323435A1 (en) 2014-04-03
HK1212900A1 (zh) 2016-06-24
SG11201501743UA (en) 2015-04-29
WO2014052678A1 (en) 2014-04-03
JP2015531377A (ja) 2015-11-02
AU2013323435B2 (en) 2017-10-19
RU2660358C2 (ru) 2018-07-05
US9452134B2 (en) 2016-09-27
MX2015003393A (es) 2015-09-25
BR112015005995A2 (pt) 2017-07-04
EP2900217A1 (en) 2015-08-05
MX358097B (es) 2018-08-06

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