KR20170126016A - 아픽사반 제제 - Google Patents

아픽사반 제제 Download PDF

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Publication number
KR20170126016A
KR20170126016A KR1020177031997A KR20177031997A KR20170126016A KR 20170126016 A KR20170126016 A KR 20170126016A KR 1020177031997 A KR1020177031997 A KR 1020177031997A KR 20177031997 A KR20177031997 A KR 20177031997A KR 20170126016 A KR20170126016 A KR 20170126016A
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KR
South Korea
Prior art keywords
apixaban
dissolution
tablets
particle size
less
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.)
Ceased
Application number
KR1020177031997A
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English (en)
Korean (ko)
Inventor
자틴 페이텔
찰스 프로스트
징핀 지아
찬드라 베마-바라푸
Original Assignee
브리스톨-마이어스 스퀴브 홀딩스 아일랜드
화이자 인코포레이티드
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43901603&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR20170126016(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 브리스톨-마이어스 스퀴브 홀딩스 아일랜드, 화이자 인코포레이티드 filed Critical 브리스톨-마이어스 스퀴브 홀딩스 아일랜드
Priority to KR1020237035193A priority Critical patent/KR20230149861A/ko
Priority to KR1020217031947A priority patent/KR20210124532A/ko
Publication of KR20170126016A publication Critical patent/KR20170126016A/ko
Ceased legal-status Critical Current

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4162—1,2-Diazoles condensed with heterocyclic ring systems
    • 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
    • A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Polyurethanes Or Polyureas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020177031997A 2010-02-25 2011-02-24 아픽사반 제제 Ceased KR20170126016A (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
KR1020237035193A KR20230149861A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020217031947A KR20210124532A (ko) 2010-02-25 2011-02-24 아픽사반 제제

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30805610P 2010-02-25 2010-02-25
US61/308,056 2010-02-25
PCT/US2011/025994 WO2011106478A2 (en) 2010-02-25 2011-02-24 Apixaban formulations

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020127022152A Division KR101796300B1 (ko) 2010-02-25 2011-02-24 아픽사반 제제

Related Child Applications (2)

Application Number Title Priority Date Filing Date
KR1020237035193A Division KR20230149861A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020217031947A Division KR20210124532A (ko) 2010-02-25 2011-02-24 아픽사반 제제

Publications (1)

Publication Number Publication Date
KR20170126016A true KR20170126016A (ko) 2017-11-15

Family

ID=43901603

Family Applications (4)

Application Number Title Priority Date Filing Date
KR1020177031997A Ceased KR20170126016A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020237035193A Ceased KR20230149861A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020217031947A Ceased KR20210124532A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020127022152A Ceased KR101796300B1 (ko) 2010-02-25 2011-02-24 아픽사반 제제

Family Applications After (3)

Application Number Title Priority Date Filing Date
KR1020237035193A Ceased KR20230149861A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020217031947A Ceased KR20210124532A (ko) 2010-02-25 2011-02-24 아픽사반 제제
KR1020127022152A Ceased KR101796300B1 (ko) 2010-02-25 2011-02-24 아픽사반 제제

Country Status (31)

Country Link
US (5) US9326945B2 (enExample)
EP (7) EP3017811B1 (enExample)
JP (4) JP5846647B2 (enExample)
KR (4) KR20170126016A (enExample)
CN (3) CN102770126A (enExample)
AU (1) AU2011220775B2 (enExample)
BR (1) BR112012021337A8 (enExample)
CA (1) CA2791171C (enExample)
CO (1) CO6640207A2 (enExample)
CY (5) CY1117434T1 (enExample)
DK (5) DK3251660T3 (enExample)
ES (5) ES2714363T3 (enExample)
HK (2) HK1243947B (enExample)
HR (5) HRP20160179T1 (enExample)
HU (4) HUE047139T2 (enExample)
IL (3) IL309564A (enExample)
IN (1) IN2012DN06587A (enExample)
LT (4) LT3251660T (enExample)
MX (3) MX353145B (enExample)
NZ (1) NZ601738A (enExample)
PE (3) PE20210468A1 (enExample)
PL (5) PL2538925T3 (enExample)
PT (5) PT3017811T (enExample)
RS (5) RS59593B1 (enExample)
RU (1) RU2685724C2 (enExample)
SG (2) SG182750A1 (enExample)
SI (5) SI2538925T1 (enExample)
SM (5) SMT201900212T1 (enExample)
TR (1) TR201903195T4 (enExample)
WO (1) WO2011106478A2 (enExample)
ZA (1) ZA201205807B (enExample)

Families Citing this family (53)

* Cited by examiner, † Cited by third party
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RU2660358C2 (ru) * 2012-09-26 2018-07-05 Бристол-Майерс Сквибб Холдингс Айеленд Жидкие лекарственные композиции апиксабана
CN102908324A (zh) * 2012-10-31 2013-02-06 南京正科制药有限公司 一种阿哌沙班片
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CN106420651B (zh) * 2016-09-28 2019-03-08 乐普药业股份有限公司 一种阿哌沙班片的制备方法
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JP7044115B2 (ja) 2017-11-27 2022-03-30 三菱ケミカル株式会社 ゴム含有グラフト重合体組成物を含む熱可塑性樹脂の樹脂改質用組成物、ゴム含有グラフト重合体含有樹脂組成物およびその成形体
KR20190075566A (ko) 2017-12-21 2019-07-01 전자부품연구원 다중 센서를 활용한 용변 습관 모니터링 시스템 및 방법
TR201722523A2 (tr) 2017-12-28 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Api̇ksaban i̇çeren kati oral farmasöti̇k kompozi̇syonlar
CN108236604A (zh) * 2018-02-07 2018-07-03 中国药科大学 阿哌沙班柔性脂质体
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WO2020034989A1 (zh) 2018-08-14 2020-02-20 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
EP3666773A1 (en) 2018-12-11 2020-06-17 KRKA, D.D., Novo Mesto Process for preparing apixaban
EP3669866A1 (en) 2018-12-19 2020-06-24 KRKA, d.d., Novo mesto Pharmaceutical composition comprising apixaban
CN111377915B (zh) * 2018-12-30 2023-10-24 鲁南制药集团股份有限公司 一种吡唑并-吡啶酮化合物晶型d
CN109464415B (zh) * 2019-01-09 2021-08-17 常州恒邦药业有限公司 阿哌沙班药物组合物及其制备方法
KR20220101103A (ko) 2019-11-13 2022-07-19 유니슨 파마슈티컬스 피브이티. 엘티디. 아픽사반의 구강 붕해성 약학적 조성물
CN111214442B (zh) * 2020-02-13 2021-12-10 山东百诺医药股份有限公司 一种阿哌沙班共微粉化物
CN111494326A (zh) * 2020-04-11 2020-08-07 南京正大天晴制药有限公司 一种阿哌沙班片及其制备方法
EP4251155A4 (en) 2020-11-27 2024-07-31 Santa Farma Ilac Sanayii A.S. IMPROVED WET GRANULATION PROCESSES FOR APIXABAN WITH FORMULATIONS
EP4251271A4 (en) 2020-11-27 2024-07-31 Santa Farma Ilac Sanayii A.S. Direct compression method for non-micronised apixaban formulations
TR202100250A2 (tr) 2021-01-08 2022-07-21 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Api̇ksaban i̇çeren fi̇lm kapli tablet
WO2022150030A2 (en) 2021-01-08 2022-07-14 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi A film coated tablet of apixaban
JP2022112698A (ja) * 2021-01-22 2022-08-03 東和薬品株式会社 アピキサバン含有医薬組成物
GB202102575D0 (en) 2021-02-23 2021-04-07 Teva Pharmaceutical Industries Ltd Fixed-dose pharmaceutical compositions
AU2022288053B2 (en) * 2021-06-08 2025-08-07 Taho Pharmaceuticals Ltd. Apixaban film product and uses thereof
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JP7834007B2 (ja) * 2022-10-12 2026-03-23 日本ジェネリック株式会社 アピキサバンを含有する錠剤
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KR102760108B1 (ko) 2024-04-09 2025-01-24 에바바이오 주식회사 수용해도와 투과도를 향상시켜 생체이용률이 개선된 무정형 아픽사반 고체분산체 제제 및 그의 서방성 정제
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