DK3781132T3 - Apixabanformuleringer - Google Patents

Apixabanformuleringer Download PDF

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Publication number
DK3781132T3
DK3781132T3 DK19722333.2T DK19722333T DK3781132T3 DK 3781132 T3 DK3781132 T3 DK 3781132T3 DK 19722333 T DK19722333 T DK 19722333T DK 3781132 T3 DK3781132 T3 DK 3781132T3
Authority
DK
Denmark
Prior art keywords
apixaban formulations
apixaban
formulations
Prior art date
Application number
DK19722333.2T
Other languages
English (en)
Inventor
Sherif Ibrahim Farag Badawy
Timothy D Stevens
Daniel Kuntz
Brett Waybrant
Original Assignee
Bristol Myers Squibb Co
Pfizer
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 Bristol Myers Squibb Co, Pfizer filed Critical Bristol Myers Squibb Co
Application granted granted Critical
Publication of DK3781132T3 publication Critical patent/DK3781132T3/da

Links

Classifications

    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK19722333.2T 2018-04-16 2019-04-15 Apixabanformuleringer DK3781132T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862658175P 2018-04-16 2018-04-16
PCT/US2019/027456 WO2019204193A1 (en) 2018-04-16 2019-04-15 Apixaban formulations

Publications (1)

Publication Number Publication Date
DK3781132T3 true DK3781132T3 (da) 2024-04-22

Family

ID=66429558

Family Applications (1)

Application Number Title Priority Date Filing Date
DK19722333.2T DK3781132T3 (da) 2018-04-16 2019-04-15 Apixabanformuleringer

Country Status (16)

Country Link
US (1) US11896586B2 (da)
EP (2) EP4353312A3 (da)
JP (1) JP7382957B2 (da)
AU (1) AU2019255599B2 (da)
BR (1) BR112020020941A2 (da)
CA (1) CA3097176A1 (da)
DK (1) DK3781132T3 (da)
FI (1) FI3781132T3 (da)
HR (1) HRP20240529T1 (da)
LT (1) LT3781132T (da)
MX (1) MX2020010673A (da)
PL (1) PL3781132T3 (da)
PT (1) PT3781132T (da)
RS (1) RS65428B1 (da)
SG (1) SG11202010097WA (da)
WO (1) WO2019204193A1 (da)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202140003A (zh) * 2020-02-13 2021-11-01 大陸商江蘇恒瑞醫藥股份有限公司 阿哌沙班注射劑用於預防或者治療血栓栓塞的方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU670567B2 (en) * 1992-03-05 1996-07-25 American Home Products Corporation Pharmaceutical coated cores
RU2218153C2 (ru) * 1997-03-26 2003-12-10 Жансен Фармасетика Н.В. Драже, имеющее ядро, покрытое противогрибковым средством и полимером
TWI331526B (en) 2001-09-21 2010-10-11 Bristol Myers Squibb Pharma Co Lactam-containing compounds and derivatives thereof as factor xa inhibitors
AU2010260208B2 (en) 2009-06-16 2014-11-13 Bristol-Myers Squibb Holdings Ireland Unlimited Company Dosage forms of apixaban
SI2538925T1 (sl) 2010-02-25 2016-04-29 Bristol-Myers Squibb Company Apiksaban formulacije
EP2554159A1 (en) * 2011-08-04 2013-02-06 ratiopharm GmbH Dosage forms comprising apixaban and content uniformity enhancer
MX351059B (es) * 2012-08-17 2017-09-29 Laboratorios Senosiain S A De C V Star Composicion farmaceutica oral en forma de microesferas y proceso de elaboracion.
SG10201702048VA (en) * 2012-09-26 2017-04-27 Bristol Myers Squibb Holdings Ireland Apixaban liquid formulations
CN105663049A (zh) 2014-11-22 2016-06-15 哈尔滨圣吉药业股份有限公司 一种阿哌沙班缓释微丸及其制备方法
US10413543B2 (en) * 2015-09-01 2019-09-17 Sun Pharma Advanced Research Company Ltd. Stable multiparticulate pharmaceutical composition of rosuvastatin
CN106913528A (zh) * 2015-12-25 2017-07-04 中美华世通生物医药科技(武汉)有限公司 阿哌沙班微丸及其制备方法

Also Published As

Publication number Publication date
MX2020010673A (es) 2020-10-28
SG11202010097WA (en) 2020-11-27
US11896586B2 (en) 2024-02-13
EP3781132B1 (en) 2024-03-20
US20210145817A1 (en) 2021-05-20
RS65428B1 (sr) 2024-05-31
JP2021521242A (ja) 2021-08-26
JP7382957B2 (ja) 2023-11-17
CA3097176A1 (en) 2019-10-24
FI3781132T3 (fi) 2024-05-31
BR112020020941A2 (pt) 2021-03-02
AU2019255599A1 (en) 2020-11-12
WO2019204193A1 (en) 2019-10-24
EP3781132A1 (en) 2021-02-24
LT3781132T (lt) 2024-04-25
HRP20240529T1 (hr) 2024-07-05
PT3781132T (pt) 2024-05-16
AU2019255599B2 (en) 2024-02-29
EP4353312A2 (en) 2024-04-17
EP4353312A3 (en) 2024-07-17
PL3781132T3 (pl) 2024-05-20

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