SI2442791T1 - Dozirna oblika apiksabana - Google Patents

Dozirna oblika apiksabana

Info

Publication number
SI2442791T1
SI2442791T1 SI201031972T SI201031972T SI2442791T1 SI 2442791 T1 SI2442791 T1 SI 2442791T1 SI 201031972 T SI201031972 T SI 201031972T SI 201031972 T SI201031972 T SI 201031972T SI 2442791 T1 SI2442791 T1 SI 2442791T1
Authority
SI
Slovenia
Prior art keywords
apixaban
dosage forms
dosage
forms
Prior art date
Application number
SI201031972T
Other languages
English (en)
Inventor
Richard G. Nause
Original Assignee
Pfizer Inc.
Bristol-Myers Squibb Holdings Ireland Unlimited Company
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 Inc., Bristol-Myers Squibb Holdings Ireland Unlimited Company filed Critical Pfizer Inc.
Publication of SI2442791T1 publication Critical patent/SI2442791T1/sl

Links

Classifications

    • 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
    • A61K9/14—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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2022—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
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • 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
SI201031972T 2009-06-16 2010-06-15 Dozirna oblika apiksabana SI2442791T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18744209P 2009-06-16 2009-06-16
PCT/US2010/038660 WO2010147978A1 (en) 2009-06-16 2010-06-15 Dosage forms of apixaban
EP10727611.5A EP2442791B1 (en) 2009-06-16 2010-06-15 Dosage forms of apixaban

Publications (1)

Publication Number Publication Date
SI2442791T1 true SI2442791T1 (sl) 2020-03-31

Family

ID=42677548

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201031972T SI2442791T1 (sl) 2009-06-16 2010-06-15 Dozirna oblika apiksabana

Country Status (23)

Country Link
US (4) US20120087978A1 (sl)
EP (2) EP2442791B1 (sl)
JP (1) JP5775071B2 (sl)
KR (1) KR20120029428A (sl)
CN (1) CN102802608A (sl)
AU (1) AU2010260208B2 (sl)
BR (1) BRPI1010739A2 (sl)
CA (1) CA2765413A1 (sl)
CY (1) CY1122685T1 (sl)
DK (1) DK2442791T3 (sl)
ES (1) ES2769357T3 (sl)
HR (1) HRP20200297T1 (sl)
HU (1) HUE048542T2 (sl)
IL (1) IL216421A0 (sl)
LT (1) LT2442791T (sl)
MX (1) MX2011013080A (sl)
PL (1) PL2442791T3 (sl)
PT (1) PT2442791T (sl)
RU (1) RU2012101214A (sl)
SG (1) SG176785A1 (sl)
SI (1) SI2442791T1 (sl)
WO (1) WO2010147978A1 (sl)
ZA (1) ZA201109334B (sl)

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EP3257500B1 (en) * 2010-02-25 2019-10-16 Bristol-Myers Squibb Holdings Ireland Unlimited Company Apixaban formulations
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WO2014052678A1 (en) * 2012-09-26 2014-04-03 Bristol-Myers Squibb Company Apixaban liquid formulations
CN104721156B (zh) * 2013-12-18 2020-05-01 山东新时代药业有限公司 一种含利伐沙班的片剂
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CN106902115A (zh) * 2015-12-22 2017-06-30 江苏万邦生化医药股份有限公司 阿哌沙班在治疗糖尿病足药物中的应用
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CN106986868B (zh) * 2016-01-21 2020-04-21 广东东阳光药业有限公司 包含阿哌沙班的共晶体及其制备方法
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CN108236604A (zh) * 2018-02-07 2018-07-03 中国药科大学 阿哌沙班柔性脂质体
JP2021514006A (ja) * 2018-02-21 2021-06-03 アーロン エイチ． ブレイジー， 膨張性の構造化された投薬剤形
DK3781132T3 (da) 2018-04-16 2024-04-22 Bristol Myers Squibb Co Apixabanformuleringer
KR20190130411A (ko) 2018-05-14 2019-11-22 신일제약주식회사 아픽사반 약제학적 제제 및 그의 제조방법
EP3838265A4 (en) * 2018-08-14 2022-05-11 Jiangsu Hengrui Medicine Co., Ltd. INJECTABLE PHARMACEUTICAL COMPOSITION AND METHOD FOR PREPARATION
CN109010273B (zh) * 2018-10-08 2021-03-19 中国药科大学 一种阿哌沙班纳米混悬剂及其制备方法
KR102045721B1 (ko) * 2019-03-27 2019-11-18 주식회사 씨트리 아픽사반 함유 미립구 제조용 분산상의 조성물 및 이로부터 제조되는 생체적합성 고분자 기반 아픽사반 함유 미립구
KR102044676B1 (ko) * 2019-03-27 2019-11-14 주식회사 씨트리 생체적합성 고분자 기반 아픽사반 함유 미립구의 제조방법
CN110037990B (zh) * 2019-04-15 2023-03-28 海正药业(杭州)有限公司 一种阿哌沙班固体无定形分散体的制备工艺
WO2020219384A1 (en) * 2019-04-26 2020-10-29 Taho Pharmaceuticals Ltd. Apixaban transdermal delivery system and uses thereof
KR20240023530A (ko) * 2021-06-08 2024-02-22 타호 파마수티컬스 엘티디 아픽사반 필름 생성물 및 이의 용도
CN115715770B (zh) * 2021-08-24 2024-01-26 新领医药技术(深圳)有限公司 阿哌沙班透皮贴剂及其制备方法

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