CA3177995A1 - Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor - Google Patents

Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor

Info

Publication number
CA3177995A1
CA3177995A1 CA3177995A CA3177995A CA3177995A1 CA 3177995 A1 CA3177995 A1 CA 3177995A1 CA 3177995 A CA3177995 A CA 3177995A CA 3177995 A CA3177995 A CA 3177995A CA 3177995 A1 CA3177995 A1 CA 3177995A1
Authority
CA
Canada
Prior art keywords
amount
ibrutinib
tablet formulation
solid tablet
formulation
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.)
Pending
Application number
CA3177995A
Other languages
English (en)
French (fr)
Inventor
Harisha ATLURI
Ching Wah Chong
Robert KUEHL
Heow TAN
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.)
Pharmacyclics LLC
Original Assignee
Pharmacyclics LLC
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=56848552&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3177995(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pharmacyclics LLC filed Critical Pharmacyclics LLC
Publication of CA3177995A1 publication Critical patent/CA3177995A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61K9/2009—Inorganic 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
    • A61K9/20—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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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

Landscapes

  • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA3177995A 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor Pending CA3177995A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562127717P 2015-03-03 2015-03-03
US62/127,717 2015-03-03
US201562193518P 2015-07-16 2015-07-16
US62/193,518 2015-07-16
CA2976695A CA2976695C (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2976695A Division CA2976695C (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor

Publications (1)

Publication Number Publication Date
CA3177995A1 true CA3177995A1 (en) 2016-09-09

Family

ID=56848552

Family Applications (3)

Application Number Title Priority Date Filing Date
CA3177995A Pending CA3177995A1 (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
CA3177990A Pending CA3177990A1 (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
CA2976695A Active CA2976695C (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA3177990A Pending CA3177990A1 (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
CA2976695A Active CA2976695C (en) 2015-03-03 2016-03-02 Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor

Country Status (28)

Country Link
US (9) US9655857B2 (enExample)
EP (2) EP3265084B1 (enExample)
JP (3) JP7149076B2 (enExample)
KR (2) KR20250016514A (enExample)
CN (4) CN107427498A (enExample)
AU (4) AU2016226279B2 (enExample)
BR (2) BR122023020985A2 (enExample)
CA (3) CA3177995A1 (enExample)
DK (1) DK3265084T3 (enExample)
ES (1) ES2971597T3 (enExample)
FI (1) FI3265084T3 (enExample)
HR (1) HRP20240231T1 (enExample)
HU (1) HUE065703T2 (enExample)
IL (3) IL315294A (enExample)
LT (1) LT3265084T (enExample)
MD (1) MD3265084T2 (enExample)
MX (5) MX394784B (enExample)
NZ (1) NZ734446A (enExample)
PL (1) PL3265084T3 (enExample)
PT (1) PT3265084T (enExample)
RS (1) RS65234B1 (enExample)
RU (1) RU2017133990A (enExample)
SG (2) SG10202102078VA (enExample)
SI (1) SI3265084T1 (enExample)
SM (1) SMT202400074T1 (enExample)
TW (6) TWI810588B (enExample)
WO (1) WO2016141068A1 (enExample)
ZA (1) ZA201907661B (enExample)

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MX380504B (es) 2010-06-03 2025-03-12 Pharmacyclics Llc El uso de inhibidores de la tirosina quinasa de bruton (btk).
MA37711A1 (fr) 2012-06-04 2017-05-31 Pharmacyclics Inc Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
HK1206073A1 (en) 2012-07-24 2015-12-31 药品循环有限责任公司 Mutations associated with resistance to inhibitors of bruton's tyrosine kinase (btk)
CA3103411A1 (en) 2013-10-25 2015-04-30 Pharmacyclics Llc Use of ibrutinib for treating and preventing chronic graft versus host disease
TW202228700A (zh) * 2013-12-02 2022-08-01 美商製藥公司 治療及預防異體抗體所驅動之慢性移植體對抗宿主疾病之方法
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
CN107530450A (zh) 2015-03-20 2018-01-02 宾夕法尼亚大学理事会 具有作为佐剂的cd40配体的疫苗
EP3892302B8 (en) * 2015-04-06 2023-10-18 Janssen Pharmaceutica NV Compositions containing ibrutinib
FI3405177T3 (fi) * 2016-01-19 2026-06-03 Janssen Pharmaceutica Nv Btk:n estäjää käsittäviä formulaatioita/koostumuksia
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
IL266842B (en) * 2016-12-01 2022-09-01 Arvinas Operations Inc History of tetrahydronaphthalene and tetrahydroisoquinoline as estrogen receptor antagonists
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
CN111278433A (zh) 2017-09-26 2020-06-12 特沙诺有限公司 尼拉帕尼制剂
CZ2017787A3 (cs) * 2017-12-08 2019-06-19 Zentiva, K.S. Farmaceutické kompozice obsahující ibrutinib
US11576917B2 (en) * 2018-01-20 2023-02-14 Natco Pharma Limited Pharmaceutical compositions comprising Ibrutinib
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EP3575300A1 (en) 2018-05-31 2019-12-04 Apotex Inc. Novel crystalline forms of ibrutinib
KR102844084B1 (ko) 2018-06-15 2025-08-07 얀센 파마슈티카 엔브이 이브루티닙을 포함하는 제형/조성물
US10688050B1 (en) 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
EP3927324A1 (en) * 2019-02-22 2021-12-29 Janssen Pharmaceutica NV Pharmaceutical formulations
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US20210228479A1 (en) * 2020-01-29 2021-07-29 Farmakeio Nutraceuticals Llc Steroidal compositions and method of making and use
EP4649945A1 (en) * 2020-11-13 2025-11-19 PTC Therapeutics, Inc. Tablet for use in treating huntington's disease and method of making the same
US11433072B1 (en) 2021-06-10 2022-09-06 Hikma Pharmaceuticals USA, Inc. Oral dosage forms of ibrutinib
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