EA201792224A1 - Композиции, содержащие ибрутиниб - Google Patents

Композиции, содержащие ибрутиниб

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Publication number
EA201792224A1
EA201792224A1 EA201792224A EA201792224A EA201792224A1 EA 201792224 A1 EA201792224 A1 EA 201792224A1 EA 201792224 A EA201792224 A EA 201792224A EA 201792224 A EA201792224 A EA 201792224A EA 201792224 A1 EA201792224 A1 EA 201792224A1
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EA
Eurasian Patent Office
Prior art keywords
lymphoma
sodium
compositions
ibrutinib
metabolite
Prior art date
Application number
EA201792224A
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English (en)
Other versions
EA033992B1 (ru
Inventor
Дилип Гоул
Маниш Кумар Гупта
Каустубх Тамбвекар
Бинурадж Кришнан Наир
Маристелла Бернини
Сабин Ингелбрехт
Original Assignee
Янссен Фармацевтика Нв
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55806788&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201792224(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Янссен Фармацевтика Нв filed Critical Янссен Фармацевтика Нв
Publication of EA201792224A1 publication Critical patent/EA201792224A1/ru
Publication of EA033992B1 publication Critical patent/EA033992B1/ru

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    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16Inorganic salts, minerals or trace elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • 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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
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    • 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
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    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/10Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic in stationary drums or troughs, provided with kneading or mixing appliances
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/22Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by pressing in moulds or between rollers
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    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
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    • 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
    • A61K9/4833Encapsulating processes; Filling of capsules

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Inorganic Chemistry (AREA)
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  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

В настоящем документе обсуждаются фармацевтические композиции, содержащие ибрутиниб, и способы их получения. Эти композиции можно применять при лечении различных состояний, включающих, без ограничений, В-клеточные пролиферативные расстройства, такие как неходжкинская лимфома (диффузная В-крупноклеточная лимфома, фолликулярная лимфома, лимфома из клеток мантийной зоны или лимфома Беркитта), макроглобулинемию Вальденстрема, плазмаклеточную миелому, хронический лимфоцитарный лейкоз, лимфому или лейкоз. Эти композиции предназначены для приема внутрь. Композиции содержатся внутри капсулы, такой как стандартная или вскрываемая капсула, или в жидком составе, таком как суспензия. В одном варианте осуществления фармацевтическая композиция содержит ибрутиниб, его соль, пролекарство или метаболит, микрокристаллическую целлюлозу, кроскармиелиозу натрия, лаурилсульфат натрия и стеарат магния. В другом варианте осуществления фармацевтическая композиция содержит ибрутиниб, его соль, пролекарство или метаболит, микрокристаллическую целлюлозу, натриевую соль карбоксиметилцеллюлозы, гидроксипропилметилцеллюлозу, лимонной кислоты моногидрат, двузамещенный гидрофосфат натрия, сукралозу, метил-пара-гидроксибензоат натрия, этил-пара-гидроксибензоат натрия, концентрированную соляную кислоту, гидроксид натрия и воду.
EA201792224A 2015-04-06 2016-04-06 Композиции, содержащие ибрутиниб EA033992B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562143659P 2015-04-06 2015-04-06
PCT/US2016/026134 WO2016164404A1 (en) 2015-04-06 2016-04-06 Compositions containing ibrutinib

Publications (2)

Publication Number Publication Date
EA201792224A1 true EA201792224A1 (ru) 2018-06-29
EA033992B1 EA033992B1 (ru) 2019-12-17

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Country Status (28)

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US (5) US20160287594A1 (ru)
EP (3) EP3280446A1 (ru)
JP (3) JP2018513852A (ru)
KR (2) KR102632745B1 (ru)
CN (2) CN113546054A (ru)
AU (3) AU2016246669B2 (ru)
CA (1) CA2981601A1 (ru)
CL (1) CL2017002512A1 (ru)
DK (1) DK3892302T3 (ru)
EA (1) EA033992B1 (ru)
ES (1) ES2964472T3 (ru)
FI (1) FI3892302T3 (ru)
HK (1) HK1250925A1 (ru)
HR (1) HRP20231207T1 (ru)
HU (1) HUE063751T2 (ru)
IL (2) IL295941A (ru)
LT (1) LT3892302T (ru)
MA (2) MA41901A (ru)
MD (1) MD3892302T2 (ru)
MX (2) MX2017012822A (ru)
PH (1) PH12017501811A1 (ru)
PL (1) PL3892302T3 (ru)
PT (1) PT3892302T (ru)
RS (1) RS64653B1 (ru)
SG (2) SG11201707989PA (ru)
SI (1) SI3892302T1 (ru)
UA (1) UA125681C2 (ru)
WO (1) WO2016164404A1 (ru)

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CN107530293A (zh) 2018-01-02
MA54411A (fr) 2021-10-13
IL254695A0 (en) 2017-11-30
PH12017501811A1 (en) 2018-04-23
ES2964472T3 (es) 2024-04-08
MD3892302T2 (ro) 2024-03-31
US20200171036A1 (en) 2020-06-04
AU2021250925A1 (en) 2021-11-11
IL254695B2 (en) 2023-02-01
CL2017002512A1 (es) 2018-03-16
MX2021015250A (es) 2022-01-24
AU2021250925B2 (en) 2023-11-16
US20170252344A1 (en) 2017-09-07
EP4272835A2 (en) 2023-11-08
KR20240013859A (ko) 2024-01-30
EA033992B1 (ru) 2019-12-17
WO2016164404A1 (en) 2016-10-13
KR20170134582A (ko) 2017-12-06
HUE063751T2 (hu) 2024-01-28
EP3892302B8 (en) 2023-10-18
CN113546054A (zh) 2021-10-26
AU2016246669B2 (en) 2021-07-15
JP2024026087A (ja) 2024-02-28
US20160287594A1 (en) 2016-10-06
SG10202103458QA (en) 2021-05-28
JP2022031690A (ja) 2022-02-22
JP7438178B2 (ja) 2024-02-26
IL295941A (en) 2022-10-01
US20230263804A1 (en) 2023-08-24
RS64653B1 (sr) 2023-10-31
AU2016246669A1 (en) 2017-10-12
PT3892302T (pt) 2023-11-15
HRP20231207T1 (hr) 2024-01-19
PL3892302T3 (pl) 2024-03-11
JP2018513852A (ja) 2018-05-31
UA125681C2 (uk) 2022-05-18
IL254695B (en) 2022-10-01
EP4272835A3 (en) 2023-12-20
CA2981601A1 (en) 2016-10-13
LT3892302T (lt) 2023-11-10
BR112017021325A2 (pt) 2018-06-26
DK3892302T3 (da) 2023-11-13
KR102632745B1 (ko) 2024-02-01
FI3892302T3 (fi) 2023-11-03
EP3280446A1 (en) 2018-02-14
AU2024200883A1 (en) 2024-02-29
SG11201707989PA (en) 2017-10-30
MA41901A (fr) 2021-04-14
SI3892302T1 (sl) 2023-11-30
EP3892302B1 (en) 2023-09-06
MA54411B1 (fr) 2023-11-30
US20220211713A1 (en) 2022-07-07
EP3892302A1 (en) 2021-10-13
HK1250925A1 (zh) 2019-01-18
MX2017012822A (es) 2018-06-13

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