AU2017208472B2 - Formulations/compositions comprising a BTK inhibitor - Google Patents

Formulations/compositions comprising a BTK inhibitor Download PDF

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Publication number
AU2017208472B2
AU2017208472B2 AU2017208472A AU2017208472A AU2017208472B2 AU 2017208472 B2 AU2017208472 B2 AU 2017208472B2 AU 2017208472 A AU2017208472 A AU 2017208472A AU 2017208472 A AU2017208472 A AU 2017208472A AU 2017208472 B2 AU2017208472 B2 AU 2017208472B2
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AU
Australia
Prior art keywords
tablet formulation
solid tablet
load solid
ibrutinib
crospovidone
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AU2017208472A
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English (en)
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AU2017208472A1 (en
Inventor
Manish Kumar Gupta
Binuraj KRISHNAN NAIR
Parikshit Rameshrao Kulkarni
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Publication of AU2017208472A1 publication Critical patent/AU2017208472A1/en
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Publication of AU2017208472B2 publication Critical patent/AU2017208472B2/en
Priority to AU2022275514A priority Critical patent/AU2022275514A1/en
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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
    • A61K9/20—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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/2022—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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth 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)
  • Oncology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2017208472A 2016-01-19 2017-01-18 Formulations/compositions comprising a BTK inhibitor Active AU2017208472B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022275514A AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201621001986 2016-01-19
IN201621001986 2016-01-19
PCT/EP2017/050962 WO2017125423A1 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a btk inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022275514A Division AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Publications (2)

Publication Number Publication Date
AU2017208472A1 AU2017208472A1 (en) 2018-07-05
AU2017208472B2 true AU2017208472B2 (en) 2022-09-01

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017208472A Active AU2017208472B2 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a BTK inhibitor
AU2022275514A Abandoned AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022275514A Abandoned AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Country Status (15)

Country Link
US (2) US20190282577A1 (enExample)
EP (1) EP3405177A1 (enExample)
JP (3) JP7109365B2 (enExample)
KR (1) KR20180101521A (enExample)
CN (1) CN108472259A (enExample)
AR (1) AR107391A1 (enExample)
AU (2) AU2017208472B2 (enExample)
BR (1) BR112018014590A2 (enExample)
CA (1) CA3008338A1 (enExample)
EA (1) EA201891440A1 (enExample)
HK (2) HK1259434A1 (enExample)
MA (1) MA43649A (enExample)
MX (3) MX2018008771A (enExample)
TW (1) TWI803454B (enExample)
WO (1) WO2017125423A1 (enExample)

Families Citing this family (12)

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KR20230170108A (ko) 2012-06-04 2023-12-18 파마싸이클릭스 엘엘씨 브루톤 타이로신 키나아제 저해제의 결정 형태
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
HRP20251152T1 (hr) * 2016-01-19 2025-12-05 Janssen Pharmaceutica Nv Formulacije/pripravci koji sadrže inhibitor btk-a
TWI808055B (zh) 2016-05-11 2023-07-11 美商滬亞生物國際有限公司 Hdac 抑制劑與 pd-1 抑制劑之組合治療
TWI794171B (zh) 2016-05-11 2023-03-01 美商滬亞生物國際有限公司 Ｈｄａｃ抑制劑與ｐｄ-ｌ１抑制劑之組合治療
JP7590810B2 (ja) 2016-10-06 2024-11-27 ヤンセン ファーマシューティカ エヌ．ベー． Ｂｔｋ阻害剤を調製するための方法および中間体
EP4467565A3 (en) 2016-12-21 2025-03-12 Amgen Inc. Anti-tnf alpha antibody formulations
EA202090573A1 (ru) 2017-09-26 2020-09-07 Тесаро, Инк. Составы нирапариба
US11576917B2 (en) 2018-01-20 2023-02-14 Natco Pharma Limited Pharmaceutical compositions comprising Ibrutinib
KR20250125432A (ko) 2018-06-15 2025-08-21 얀센 파마슈티카 엔브이 이브루티닙을 포함하는 제형/조성물
US10688050B1 (en) * 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising 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

Citations (3)

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WO2014004707A1 (en) * 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
US20140336203A1 (en) * 2012-06-04 2014-11-13 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor
WO2016141068A1 (en) * 2015-03-03 2016-09-09 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibtor

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US20140336203A1 (en) * 2012-06-04 2014-11-13 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor
WO2014004707A1 (en) * 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
WO2016141068A1 (en) * 2015-03-03 2016-09-09 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibtor

Also Published As

Publication number Publication date
JP2024023184A (ja) 2024-02-21
KR20180101521A (ko) 2018-09-12
TWI803454B (zh) 2023-06-01
MX2022006768A (es) 2022-06-17
JP7109365B2 (ja) 2022-07-29
MX2018008771A (es) 2018-11-09
MX2024009894A (es) 2024-09-10
HK1259434A1 (zh) 2019-11-29
HK1259440A1 (zh) 2019-11-29
CN108472259A (zh) 2018-08-31
AR107391A1 (es) 2018-04-25
AU2017208472A1 (en) 2018-07-05
WO2017125423A1 (en) 2017-07-27
US20190282577A1 (en) 2019-09-19
CA3008338A1 (en) 2017-07-27
MA43649A (fr) 2018-11-28
US20220339157A1 (en) 2022-10-27
EA201891440A1 (ru) 2018-12-28
BR112018014590A2 (pt) 2018-12-11
EP3405177A1 (en) 2018-11-28
JP2019506387A (ja) 2019-03-07
AU2022275514A1 (en) 2023-01-05
TW201731513A (zh) 2017-09-16
JP2022105009A (ja) 2022-07-12

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