AU2016246669B2 - Compositions containing Ibrutinib - Google Patents

Compositions containing Ibrutinib Download PDF

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Publication number
AU2016246669B2
AU2016246669B2 AU2016246669A AU2016246669A AU2016246669B2 AU 2016246669 B2 AU2016246669 B2 AU 2016246669B2 AU 2016246669 A AU2016246669 A AU 2016246669A AU 2016246669 A AU2016246669 A AU 2016246669A AU 2016246669 B2 AU2016246669 B2 AU 2016246669B2
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AU
Australia
Prior art keywords
sodium
composition
pharmaceutical composition
lymphoma
ibrutinib
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.)
Active
Application number
AU2016246669A
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English (en)
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AU2016246669A1 (en
Inventor
Maristella BERNINI
Dilip Gole
Manish Kumar Gupta
Sabine INGHELBRECHT
Binuraj Krishnan NAIR
Kaustubh TAMBWEKAR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Pharmaceutica NV
Original Assignee
Janssen Pharmaceutica NV
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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=AU2016246669(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Publication of AU2016246669A1 publication Critical patent/AU2016246669A1/en
Application granted granted Critical
Publication of AU2016246669B2 publication Critical patent/AU2016246669B2/en
Priority to AU2021250925A priority Critical patent/AU2021250925B2/en
Priority to AU2024200883A priority patent/AU2024200883A1/en
Priority to AU2026200996A priority patent/AU2026200996A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/10—Processes 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/22—Processes 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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Dispersion Chemistry (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Physiology (AREA)
  • 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)
AU2016246669A 2015-04-06 2016-04-06 Compositions containing Ibrutinib Active AU2016246669B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2021250925A AU2021250925B2 (en) 2015-04-06 2021-10-14 Compositions containing Ibrutinib
AU2024200883A AU2024200883A1 (en) 2015-04-06 2024-02-12 Compositions containing Ibrutinib
AU2026200996A AU2026200996A1 (en) 2015-04-06 2026-02-11 Compositions containing Ibrutinib

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562143659P 2015-04-06 2015-04-06
US62/143,659 2015-04-06
PCT/US2016/026134 WO2016164404A1 (en) 2015-04-06 2016-04-06 Compositions containing ibrutinib

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021250925A Division AU2021250925B2 (en) 2015-04-06 2021-10-14 Compositions containing Ibrutinib

Publications (2)

Publication Number Publication Date
AU2016246669A1 AU2016246669A1 (en) 2017-10-12
AU2016246669B2 true AU2016246669B2 (en) 2021-07-15

Family

ID=55806788

Family Applications (4)

Application Number Title Priority Date Filing Date
AU2016246669A Active AU2016246669B2 (en) 2015-04-06 2016-04-06 Compositions containing Ibrutinib
AU2021250925A Active AU2021250925B2 (en) 2015-04-06 2021-10-14 Compositions containing Ibrutinib
AU2024200883A Abandoned AU2024200883A1 (en) 2015-04-06 2024-02-12 Compositions containing Ibrutinib
AU2026200996A Pending AU2026200996A1 (en) 2015-04-06 2026-02-11 Compositions containing Ibrutinib

Family Applications After (3)

Application Number Title Priority Date Filing Date
AU2021250925A Active AU2021250925B2 (en) 2015-04-06 2021-10-14 Compositions containing Ibrutinib
AU2024200883A Abandoned AU2024200883A1 (en) 2015-04-06 2024-02-12 Compositions containing Ibrutinib
AU2026200996A Pending AU2026200996A1 (en) 2015-04-06 2026-02-11 Compositions containing Ibrutinib

Country Status (29)

Country Link
US (6) US20160287594A1 (enExample)
EP (3) EP3892302B8 (enExample)
JP (4) JP2018513852A (enExample)
KR (2) KR20240013859A (enExample)
CN (2) CN107530293A (enExample)
AU (4) AU2016246669B2 (enExample)
CA (1) CA2981601A1 (enExample)
CL (1) CL2017002512A1 (enExample)
DK (1) DK3892302T3 (enExample)
EA (1) EA033992B1 (enExample)
ES (1) ES2964472T3 (enExample)
FI (1) FI3892302T3 (enExample)
HK (1) HK1250925A1 (enExample)
HR (1) HRP20231207T1 (enExample)
HU (1) HUE063751T2 (enExample)
IL (2) IL295941A (enExample)
LT (1) LT3892302T (enExample)
MA (2) MA54411B1 (enExample)
MD (1) MD3892302T2 (enExample)
MX (2) MX2017012822A (enExample)
PH (1) PH12017501811A1 (enExample)
PL (1) PL3892302T3 (enExample)
PT (1) PT3892302T (enExample)
RS (1) RS64653B1 (enExample)
SG (2) SG11201707989PA (enExample)
SI (1) SI3892302T1 (enExample)
SM (1) SMT202300422T1 (enExample)
UA (1) UA125681C2 (enExample)
WO (1) WO2016164404A1 (enExample)

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MA37711A1 (fr) 2012-06-04 2017-05-31 Pharmacyclics Inc Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
US9545407B2 (en) 2014-08-07 2017-01-17 Pharmacyclics Llc Formulations of a bruton's tyrosine kinase inhibitor
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of proton tyrosine kinase inhibitor
EP3892302B8 (en) 2015-04-06 2023-10-18 Janssen Pharmaceutica NV Compositions containing ibrutinib
CN109790121B (zh) 2016-10-06 2024-01-05 詹森药业有限公司 用于制备btk抑制剂的方法和中间体
WO2018167628A1 (en) 2017-03-13 2018-09-20 Ftf Pharma Private Limited Pharmaceutical composition of oral suspension of immunosuppressive agents
CN108653231A (zh) * 2017-04-01 2018-10-16 北京赛林泰医药技术有限公司 含有布鲁顿酪氨酸激酶抑制剂的组合物及其制备方法
CN107014943B (zh) * 2017-06-07 2018-08-21 福建省微生物研究所 一种依鲁替尼对映异构体的检测方法
WO2019038584A1 (en) 2017-08-19 2019-02-28 Ftf Pharma Private Limited An oral pharmaceutical composition comprising zonisamide and process of preparation thereof
CN111278433A (zh) 2017-09-26 2020-06-12 特沙诺有限公司 尼拉帕尼制剂
US11576917B2 (en) 2018-01-20 2023-02-14 Natco Pharma Limited Pharmaceutical compositions comprising Ibrutinib
KR20190122561A (ko) * 2018-04-21 2019-10-30 류형준 림프 순환 장애의 치료 또는 경감을 위한 약학적 조성물과 식품 조성물
KR102844084B1 (ko) * 2018-06-15 2025-08-07 얀센 파마슈티카 엔브이 이브루티닙을 포함하는 제형/조성물
GB2591396B (en) 2018-08-18 2023-06-07 Ftf Pharma Private Ltd Pharmaceutical suspension for oral dosage
US12083222B2 (en) 2018-08-18 2024-09-10 Oncosol Limited Chemotherapeutic pharmaceutical suspension for oral dosage
KR102198502B1 (ko) * 2018-09-16 2021-01-05 류형준 인체의 림프순환 개선을 위한 식품 조성물
JP2022513666A (ja) * 2018-11-30 2022-02-09 ヤンセン バイオテツク，インコーポレーテツド 濾胞性リンパ腫の治療方法
US10688050B1 (en) 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
KR20230008775A (ko) 2020-05-08 2023-01-16 젠맵 에이/에스 Cd3 및 cd20에 대한 이중특이적 항체
KR102251435B1 (ko) * 2020-11-09 2021-05-11 류형준 림프순환 촉진에 의한 부종 개선을 위한 식품 조성물
US11433072B1 (en) * 2021-06-10 2022-09-06 Hikma Pharmaceuticals USA, Inc. Oral dosage forms of ibrutinib
TN2023000295A1 (en) * 2021-06-10 2025-07-02 Hikma Pharmaceuticals Usa Inc Oral dosage forms of ibrutinib
CN117064862B (zh) * 2023-04-10 2025-12-19 山东新时代药业有限公司 一种伊布替尼肠溶片及其制备方法

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