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EP4251155A4 - Improved wet granulation processes for apixaban comprising formulations - Google Patents

Improved wet granulation processes for apixaban comprising formulations

Info

Publication number
EP4251155A4
EP4251155A4 EP20963794.1A EP20963794A EP4251155A4 EP 4251155 A4 EP4251155 A4 EP 4251155A4 EP 20963794 A EP20963794 A EP 20963794A EP 4251155 A4 EP4251155 A4 EP 4251155A4
Authority
EP
European Patent Office
Prior art keywords
apixaban
formulations
wet granulation
improved wet
granulation processes
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.)
Pending
Application number
EP20963794.1A
Other languages
German (de)
French (fr)
Other versions
EP4251155A1 (en
Inventor
Erol Kiresepi
Ersin Yildirim
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.)
Santa Farma Ilac Sanayi AS
Original Assignee
Santa Farma Ilac Sanayi AS
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 Santa Farma Ilac Sanayi AS filed Critical Santa Farma Ilac Sanayi AS
Publication of EP4251155A1 publication Critical patent/EP4251155A1/en
Publication of EP4251155A4 publication Critical patent/EP4251155A4/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP20963794.1A 2020-11-27 2020-11-27 Improved wet granulation processes for apixaban comprising formulations Pending EP4251155A4 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2020/051185 WO2022115052A1 (en) 2020-11-27 2020-11-27 Improved wet granulation processes for apixaban comprising formulations

Publications (2)

Publication Number Publication Date
EP4251155A1 EP4251155A1 (en) 2023-10-04
EP4251155A4 true EP4251155A4 (en) 2024-07-31

Family

ID=81754730

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20963794.1A Pending EP4251155A4 (en) 2020-11-27 2020-11-27 Improved wet granulation processes for apixaban comprising formulations

Country Status (2)

Country Link
EP (1) EP4251155A4 (en)
WO (1) WO2022115052A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017121340A1 (en) * 2016-01-12 2017-07-20 广东东阳光药业有限公司 Araxaban solid composition and preparation method therefor
WO2018150286A1 (en) * 2017-02-17 2018-08-23 Unichem Laboratories Ltd Pharmaceutical composition of apixaban

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2329881T3 (en) 2001-09-21 2009-12-02 Bristol-Myers Squibb Company COMPOUNDS CONTAINING LACTAMA AND DERIVATIVES OF THE SAME AS INHIBITORS OF FACTOR XA.
PT2538925E (en) 2010-02-25 2016-03-18 Pfizer Apixaban formulations
EP2554159A1 (en) 2011-08-04 2013-02-06 ratiopharm GmbH Dosage forms comprising apixaban and content uniformity enhancer
CN104644593A (en) * 2013-11-23 2015-05-27 天津市汉康医药生物技术有限公司 Apixaban composition and preparation method thereof
EP2907507A1 (en) 2014-02-17 2015-08-19 Sandoz Ag Pharmaceutical composition comprising apixaban
EP3195860A1 (en) 2016-01-22 2017-07-26 STADA Arzneimittel AG Method for producing an apixaban granulate
WO2017163170A1 (en) 2016-03-21 2017-09-28 Sun Pharmaceutical Industries Limited Pharmaceutical composition comprising apixaban
WO2017182908A1 (en) 2016-04-18 2017-10-26 Emcure Pharmaceuticals Limited Pharmaceutical compositions of apixaban
EP3243505A1 (en) 2016-05-13 2017-11-15 Zaklady Farmaceutyczne Polpharma SA A pharmaceutical composition comprising amorphous apixaban
WO2017221209A1 (en) 2016-06-23 2017-12-28 Lupin Limited Pharmaceutical formulations of apixaban
TR201717703A2 (en) 2017-11-10 2019-05-21 Ali Raif Ilac Sanayi Ve Ticaret Anonim Sirketi APIXABAN FORMULATIONS
KR102128321B1 (en) 2018-03-13 2020-06-30 주식회사 종근당 Solubilization formulation comprising apixaban and preparation method for the same

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017121340A1 (en) * 2016-01-12 2017-07-20 广东东阳光药业有限公司 Araxaban solid composition and preparation method therefor
WO2018150286A1 (en) * 2017-02-17 2018-08-23 Unichem Laboratories Ltd Pharmaceutical composition of apixaban

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2022115052A1 *

Also Published As

Publication number Publication date
WO2022115052A1 (en) 2022-06-02
EP4251155A1 (en) 2023-10-04

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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Effective date: 20230511

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Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20240701

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/20 20060101ALI20240625BHEP

Ipc: A61P 7/02 20060101ALI20240625BHEP

Ipc: A61K 9/28 20060101ALI20240625BHEP

Ipc: A61K 31/4545 20060101AFI20240625BHEP