PL3897586T3 - Kompozycja farmaceutyczna zawierająca apiksaban - Google Patents

Kompozycja farmaceutyczna zawierająca apiksaban

Info

Publication number
PL3897586T3
PL3897586T3 PL19827727.9T PL19827727T PL3897586T3 PL 3897586 T3 PL3897586 T3 PL 3897586T3 PL 19827727 T PL19827727 T PL 19827727T PL 3897586 T3 PL3897586 T3 PL 3897586T3
Authority
PL
Poland
Prior art keywords
apixaban
pharmaceutical composition
pharmaceutical
composition
Prior art date
Application number
PL19827727.9T
Other languages
English (en)
Inventor
Gregor Lorbek
Danijel Videc
Korasa Klemen
Klavdija Meznar
Tadeja Birsa CELIC
Original Assignee
Krka, D.D., Novo Mesto
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 Krka, D.D., Novo Mesto filed Critical Krka, D.D., Novo Mesto
Publication of PL3897586T3 publication Critical patent/PL3897586T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K47/30Macromolecular 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
PL19827727.9T 2018-12-19 2019-12-19 Kompozycja farmaceutyczna zawierająca apiksaban PL3897586T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18214161.4A EP3669866A1 (en) 2018-12-19 2018-12-19 Pharmaceutical composition comprising apixaban
PCT/EP2019/086437 WO2020127819A2 (en) 2018-12-19 2019-12-19 Pharmaceutical composition comprising apixaban

Publications (1)

Publication Number Publication Date
PL3897586T3 true PL3897586T3 (pl) 2026-03-09

Family

ID=64746234

Family Applications (1)

Application Number Title Priority Date Filing Date
PL19827727.9T PL3897586T3 (pl) 2018-12-19 2019-12-19 Kompozycja farmaceutyczna zawierająca apiksaban

Country Status (5)

Country Link
EP (2) EP3669866A1 (pl)
EA (1) EA202191515A1 (pl)
PL (1) PL3897586T3 (pl)
SI (1) SI3897586T1 (pl)
WO (1) WO2020127819A2 (pl)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE073416T2 (hu) 2019-11-13 2026-01-28 Unison Pharmaceuticals Pvt Ltd Az apixaban orálisan dezintegrálódó gyógyszerkészítményei
JP7520351B2 (ja) * 2020-08-14 2024-07-23 日医工株式会社 アピキサバン含有医薬組成物
WO2022115051A1 (en) * 2020-11-27 2022-06-02 Santa Farma Ilac Sanayii A.S. Direct compression method for non-micronised apixaban formulations
US12036216B2 (en) * 2021-06-08 2024-07-16 Taho Pharmaceuticals Ltd. Apixaban film product and uses thereof
CN114939111A (zh) * 2022-06-17 2022-08-26 哈药集团技术中心 一种艾多沙班片的制备方法
CN117562900B (zh) * 2023-12-01 2025-07-18 广东万泰科创药业有限公司 一种阿哌沙班口腔崩解片剂组合物及其制备方法
JP7854233B2 (ja) 2024-10-10 2026-05-01 富士化学工業株式会社 アピキサバン含有組成物、アピキサバン含有固形製剤、及びアピキサバン含有固形製剤の製造方法

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI320039B (en) 2001-09-21 2010-02-01 Lactam-containing compounds and derivatives thereof as factor xa inhibitors
SI2538925T1 (sl) 2010-02-25 2016-04-29 Bristol-Myers Squibb Company Apiksaban formulacije
US20150018386A1 (en) 2012-03-06 2015-01-15 Cadila Healthcare Limited Amorphous form of apixaban, process of preparation and compositions thereof
CA2873949A1 (en) * 2012-05-24 2013-11-28 Ratiopharm Gmbh Dosage forms comprising apixaban and matrix former
WO2014203275A2 (en) 2013-06-18 2014-12-24 Cadila Healthcare Limited An improved process for the preparation of apixaban and intermediates thereof
CN105848644A (zh) 2013-12-23 2016-08-10 埃斯特韦实验室有限公司 经口药物组合物
EP3089736B1 (en) 2013-12-31 2025-07-23 Ascendia Pharmaceuticals, LLC Pharmaceutical compositions for poorly water-soluble compounds
EP2907507A1 (en) 2014-02-17 2015-08-19 Sandoz Ag Pharmaceutical composition comprising apixaban
WO2017088841A1 (en) 2015-11-26 2017-06-01 Zentiva, K.S. Preparation of a drug form containing amorphous apixaban
EP3195860A1 (de) 2016-01-22 2017-07-26 STADA Arzneimittel AG Verfahren zur herstellung eines apixaban-granulates
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
KR102128321B1 (ko) * 2018-03-13 2020-06-30 주식회사 종근당 아픽사반을 포함하는 가용화를 위한 약제학적 제제 및 이의 제조 방법

Also Published As

Publication number Publication date
EA202191515A1 (ru) 2021-10-26
WO2020127819A2 (en) 2020-06-25
EP3669866A1 (en) 2020-06-24
EP3897586B1 (en) 2025-11-05
WO2020127819A3 (en) 2020-07-30
SI3897586T1 (sl) 2026-02-27
EP3897586A2 (en) 2021-10-27

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