AU2013323435C1 - Apixaban liquid formulations - Google Patents

Apixaban liquid formulations Download PDF

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Publication number
AU2013323435C1
AU2013323435C1 AU2013323435A AU2013323435A AU2013323435C1 AU 2013323435 C1 AU2013323435 C1 AU 2013323435C1 AU 2013323435 A AU2013323435 A AU 2013323435A AU 2013323435 A AU2013323435 A AU 2013323435A AU 2013323435 C1 AU2013323435 C1 AU 2013323435C1
Authority
AU
Australia
Prior art keywords
vehicle
apixaban
liquid formulation
less
equal
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.)
Active
Application number
AU2013323435A
Other languages
English (en)
Other versions
AU2013323435A8 (en
AU2013323435A1 (en
AU2013323435B2 (en
Inventor
Sherif Ibrahim Farag Badawy
Susan Lum
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
Pfizer Corp SRL
Original Assignee
Pfizer Corp Belgium
Bristol Myers Squibb Holdings Ireland ULC
Pfizer Corp SRL
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 Pfizer Corp Belgium, Bristol Myers Squibb Holdings Ireland ULC, Pfizer Corp SRL filed Critical Pfizer Corp Belgium
Publication of AU2013323435A1 publication Critical patent/AU2013323435A1/en
Publication of AU2013323435A8 publication Critical patent/AU2013323435A8/en
Assigned to BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, PFIZER INC. reassignment BRISTOL-MYERS SQUIBB HOLDINGS IRELAND Request for Assignment Assignors: BRISTOL-MYERS SQUIBB COMPANY, PFIZER INC.
Application granted granted Critical
Publication of AU2013323435B2 publication Critical patent/AU2013323435B2/en
Publication of AU2013323435C1 publication Critical patent/AU2013323435C1/en
Assigned to PFIZER INC., BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED COMPANY reassignment PFIZER INC. Request to Amend Deed and Register Assignors: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, PFIZER INC.
Active 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
    • A61K31/4353Heterocyclic 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2013323435A 2012-09-26 2013-09-26 Apixaban liquid formulations Active AU2013323435C1 (en)

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 (4)

Publication Number Publication Date
AU2013323435A1 AU2013323435A1 (en) 2014-04-03
AU2013323435A8 AU2013323435A8 (en) 2015-04-23
AU2013323435B2 AU2013323435B2 (en) 2017-10-19
AU2013323435C1 true AU2013323435C1 (en) 2018-04-12

Family

ID=49447800

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013323435A Active AU2013323435C1 (en) 2012-09-26 2013-09-26 Apixaban liquid formulations

Country Status (18)

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

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
DK3781132T3 (da) * 2018-04-16 2024-04-22 Bristol Myers Squibb Co Apixabanformuleringer
CN112261935A (zh) 2018-08-14 2021-01-22 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
US20220211689A1 (en) 2019-11-13 2022-07-07 Unison Pharmaceuticals Pvt. Ltd. Orally disintegrating pharmaceutical compositions of apixaban
CA3202161A1 (en) 2020-12-13 2022-06-16 Matthaios VIDALIS 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
EP4412586A1 (en) 2021-10-27 2024-08-14 Pharma-Data 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
WO2024160789A1 (en) 2023-01-30 2024-08-08 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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007022165A2 (en) * 2005-08-17 2007-02-22 Bristol-Myers Squibb Company Factor xa inhibitor inclusion complex with cyclodextrin
WO2010147978A1 (en) * 2009-06-16 2010-12-23 Pfizer Inc. Dosage forms of apixaban
WO2011106478A2 (en) * 2010-02-25 2011-09-01 Bristol-Myers Squibb Company Apixaban formulations

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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
CZ20022047A3 (cs) 1999-12-23 2003-09-17 Pfizer Products Inc. Farmaceutické kompozice poskytující zvýšenou koncentraci léčiva
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
SI1427415T1 (sl) * 2001-09-21 2009-12-31 Bristol Myers Squibb Co Sestavine, ki vsebujejo laktame in njihovi derivati kot inhibitorji faktorja 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
CA2712120A1 (en) * 2008-01-14 2009-07-23 Foamix Ltd. Poloxamer foamable pharmaceutical compositions with active agents and/or therapeutic cells and uses
DK3100728T3 (da) * 2009-05-13 2020-02-17 Cydex Pharmaceuticals Inc Farmaceutiske sammensætninger omfattende prasugrel og cyclodextrin-derivativ og fremgangsmåder til fremstilling og brug af samme
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

Patent Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2007022165A2 (en) * 2005-08-17 2007-02-22 Bristol-Myers Squibb Company Factor xa inhibitor inclusion complex with cyclodextrin
WO2010147978A1 (en) * 2009-06-16 2010-12-23 Pfizer Inc. Dosage forms of apixaban
WO2011106478A2 (en) * 2010-02-25 2011-09-01 Bristol-Myers Squibb Company Apixaban formulations

Also Published As

Publication number Publication date
CN104736142B (zh) 2020-03-03
CA2885899A1 (en) 2014-04-03
EP2900217A1 (en) 2015-08-05
US20150224053A1 (en) 2015-08-13
AU2013323435A8 (en) 2015-04-23
IN2015DN01902A (enExample) 2015-08-07
BR112015005995A2 (pt) 2017-07-04
NZ630763A (en) 2017-01-27
KR102035373B1 (ko) 2019-10-22
RU2660358C2 (ru) 2018-07-05
JP6248112B2 (ja) 2017-12-13
MX2015003393A (es) 2015-09-25
US9452134B2 (en) 2016-09-27
MY179191A (en) 2020-10-30
KR20150058243A (ko) 2015-05-28
US10016362B2 (en) 2018-07-10
MX358097B (es) 2018-08-06
AU2013323435A1 (en) 2014-04-03
WO2014052678A1 (en) 2014-04-03
RU2015115127A (ru) 2016-11-20
PH12015500590A1 (en) 2015-05-25
SG11201501743UA (en) 2015-04-29
CN104736142A (zh) 2015-06-24
PH12015500590B1 (en) 2019-08-23
AU2013323435B2 (en) 2017-10-19
JP2015531377A (ja) 2015-11-02
IL237804A0 (en) 2015-05-31
HK1212900A1 (zh) 2016-06-24
US20160263097A1 (en) 2016-09-15
SG10201702048VA (en) 2017-04-27

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TH Corrigenda

Free format text: IN VOL 29 , NO 14 , PAGE(S) 2151 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME PFIZER INC.; BRISTOL-MYERS SQU BB COMPANY, APPLICATION NO. 2013323435, UNDER INID (72) ADD CO-INVENTOR LUM, SUSAN

PC1 Assignment before grant (sect. 113)

Owner name: PFIZER INC.; BRISTOL-MYERS SQUIBB HOLDINGS IRELAND

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DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ BADAWY, SHERIF IBRAHIM FARAG AND LUM, SUSAN

DA2 Applications for amendment section 104

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Owner name: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND UNLIMITED CO

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