CR20230018A - Formas farmacéuticas de maleato de acalabrutinib - Google Patents

Formas farmacéuticas de maleato de acalabrutinib

Info

Publication number
CR20230018A
CR20230018A CR20230018A CR20230018A CR20230018A CR 20230018 A CR20230018 A CR 20230018A CR 20230018 A CR20230018 A CR 20230018A CR 20230018 A CR20230018 A CR 20230018A CR 20230018 A CR20230018 A CR 20230018A
Authority
CR
Costa Rica
Prior art keywords
dosage forms
pharmaceutical dosage
acalabrutinib
methods
maleate
Prior art date
Application number
CR20230018A
Other languages
English (en)
Inventor
John Blyth
David Simpson
James Mann
Paul Bethel
Steve Cosgrove
Michael Golden
Xavier Jacques Henri Pepin
Andrew Robbins
Original Assignee
Acerta Pharma Bv
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 Acerta Pharma Bv filed Critical Acerta Pharma Bv
Publication of CR20230018A publication Critical patent/CR20230018A/es

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
    • A61K31/495—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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/205—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
    • A61K9/0012—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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente divulgación se refiere, en general, a: (a) formas farmacéuticas sólidas que comprenden maleato de acalabrutinib; (b) métodos de uso de dichas formas farmacéuticas para tratar neoplasias de linfocitos B y/u otras afecciones; (c) kits que comprenden dichas formas farmacéuticas y, opcionalmente, una segunda forma farmacéutica que comprende otro agente terapéutico; (d) métodos de preparación de dichas formas farmacéuticas; y (e) formas farmacéuticas preparadas mediante dichos métodos.<br /> <br />
CR20230018A 2020-06-19 2021-06-18 Formas farmacéuticas de maleato de acalabrutinib CR20230018A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063041197P 2020-06-19 2020-06-19
PCT/EP2021/066629 WO2021255246A1 (en) 2020-06-19 2021-06-18 Acalabrutinib maleate dosage forms

Publications (1)

Publication Number Publication Date
CR20230018A true CR20230018A (es) 2023-04-11

Family

ID=76829497

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20230018A CR20230018A (es) 2020-06-19 2021-06-18 Formas farmacéuticas de maleato de acalabrutinib

Country Status (19)

Country Link
US (1) US20230226049A1 (es)
EP (1) EP4167968A1 (es)
JP (1) JP7821749B2 (es)
KR (1) KR20230027201A (es)
CN (1) CN115916161A (es)
AR (1) AR122681A1 (es)
AU (2) AU2021291437B2 (es)
CA (1) CA3186141A1 (es)
CL (1) CL2022003620A1 (es)
CO (1) CO2023000536A2 (es)
CR (1) CR20230018A (es)
DO (1) DOP2022000287A (es)
IL (1) IL298872A (es)
MX (1) MX2022016341A (es)
PE (1) PE20230992A1 (es)
PH (1) PH12022553376A1 (es)
TW (2) TWI889851B (es)
UY (1) UY39288A (es)
WO (1) WO2021255246A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115192536A (zh) * 2022-01-06 2022-10-18 江苏奥赛康药业有限公司 一种含有奈玛特韦的药用组合物及其制备方法
WO2024084496A1 (en) * 2022-10-17 2024-04-25 Natco Pharma Limited Pharmaceutical compositions comprising acalabrutinib maleate
WO2024164066A1 (en) * 2023-02-09 2024-08-15 Apotex Inc Crystalline forms of acalabrutinib maleate

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3566697B1 (en) * 2009-11-09 2024-09-11 Wyeth LLC Tablet formulations of neratinib maleate
CN103889987B (zh) 2011-07-19 2016-09-14 默沙东有限责任公司 作为btk抑制剂的选择的咪唑并吡嗪类
EP2572703A1 (en) * 2011-09-21 2013-03-27 Hexal AG Compressed oral dosage form for asenapine maleate
MX376083B (es) * 2015-06-04 2025-03-07 Pfizer Formas de dosificacion solidas de palbociclib.
IL293821A (en) * 2015-07-02 2022-08-01 Acerta Pharma Bv Solid forms and formulations of (S)-4-(8-amino-3-(1-(but-2-aminoyl)pyrrolidine-2-yl)imidazo[5,1-yl]pyrazin-1-yl)-en- (pyridine-2-yl)benzamide
WO2017077507A1 (en) * 2015-11-06 2017-05-11 Acerta Pharma B.V. Imidazopyrazine inhibitors of bruton's tyrosine kinase
US10899770B2 (en) * 2017-02-20 2021-01-26 Hangzhou Solipharma Co., Ltd. Crystal form of ACP-196 salt and preparation method, pharmaceutical composition, and use thereof
TWI787523B (zh) * 2018-06-15 2022-12-21 漢達生技醫藥股份有限公司 達沙替尼十二烷基硫酸鹽之結晶
KR20250119664A (ko) 2018-08-29 2025-08-07 아세르타 파마. 비.브이. 4-｛8-아미노-3-[(2S)-1-(부트-2-이노일)-피롤리딘-2-일]이미다조[1,5-a]-피라진-1-일｝N-(피리딘-2-일)-벤즈아미드의제조 공정

Also Published As

Publication number Publication date
TW202200145A (zh) 2022-01-01
CL2022003620A1 (es) 2023-05-05
DOP2022000287A (es) 2023-03-15
US20230226049A1 (en) 2023-07-20
BR112022025611A2 (pt) 2023-01-03
PH12022553376A1 (en) 2024-03-25
JP7821749B2 (ja) 2026-02-27
CN115916161A (zh) 2023-04-04
EP4167968A1 (en) 2023-04-26
JP2023531606A (ja) 2023-07-25
TW202610630A (zh) 2026-03-16
PE20230992A1 (es) 2023-06-23
AU2021291437B2 (en) 2024-07-04
MX2022016341A (es) 2023-01-24
CA3186141A1 (en) 2021-12-23
UY39288A (es) 2022-01-31
TWI889851B (zh) 2025-07-11
WO2021255246A1 (en) 2021-12-23
AR122681A1 (es) 2022-09-28
KR20230027201A (ko) 2023-02-27
IL298872A (en) 2023-02-01
CO2023000536A2 (es) 2023-01-26
AU2024204906A1 (en) 2024-08-01
AU2021291437A1 (en) 2023-02-16

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