CO2023000536A2 - Formas farmacéuticas de maleato de acalabrutinib - Google Patents

Formas farmacéuticas de maleato de acalabrutinib

Info

Publication number
CO2023000536A2
CO2023000536A2 CONC2023/0000536A CO2023000536A CO2023000536A2 CO 2023000536 A2 CO2023000536 A2 CO 2023000536A2 CO 2023000536 A CO2023000536 A CO 2023000536A CO 2023000536 A2 CO2023000536 A2 CO 2023000536A2
Authority
CO
Colombia
Prior art keywords
dosage forms
acalabrutinib
maleate
methods
maleate dosage
Prior art date
Application number
CONC2023/0000536A
Other languages
English (en)
Inventor
Paul Bethel
John Blyth
Steve Cosgrove
Michael Golden
James Mann
Xavier Jacques Henri Pepin
Andrew Robbins
David Simpson
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 CO2023000536A2 publication Critical patent/CO2023000536A2/es

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
    • A61K9/2013—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
    • 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
    • A61K9/0012—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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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.
CONC2023/0000536A 2020-06-19 2023-01-18 Formas farmacéuticas de maleato de acalabrutinib CO2023000536A2 (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
CO2023000536A2 true CO2023000536A2 (es) 2023-01-26

Family

ID=76829497

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2023/0000536A CO2023000536A2 (es) 2020-06-19 2023-01-18 Formas farmacéuticas de maleato de acalabrutinib

Country Status (19)

Country Link
US (1) US20230226049A1 (es)
EP (1) EP4167968A1 (es)
JP (1) JP2023531606A (es)
KR (1) KR20230027201A (es)
CN (1) CN115916161A (es)
AR (1) AR122681A1 (es)
AU (2) AU2021291437B2 (es)
BR (1) BR112022025611A2 (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)
TW (1) TW202200145A (es)
UY (1) UY39288A (es)
WO (1) WO2021255246A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS59599B2 (sr) * 2009-11-09 2023-03-31 Wyeth Llc Formulacije tableta neratinib maleata
HUE041987T2 (hu) 2011-07-19 2019-06-28 Merck Sharp & Dohme 4-Imidazopiridazin-1-il-benzamidok és 4-imidazotriazin-1-il-benzamidok mint BTK-gátlók
EP2572703A1 (en) * 2011-09-21 2013-03-27 Hexal AG Compressed oral dosage form for asenapine maleate
KR102068423B1 (ko) * 2015-06-04 2020-01-20 화이자 인코포레이티드 팔보시클립의 고체 투여 형태
MX2018000179A (es) * 2015-07-02 2018-06-27 Acerta Pharma Bv Formas solidas y formulaciones de (s)-4-(8-amino-3-(1-(but-2-inoil )pirrolidin-2-il)imidazo[1,5-a]pirazin-1-il)-n-(piridin-2-il)benz amida.
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
JP7439095B2 (ja) 2018-08-29 2024-02-27 アセルタ・ファーマ・ベスローテン・フェンノートシャップ ４－｛８－アミノ－３－［（２Ｓ）－１－（ブタ－２－イノイル）－ピロリジン－２－イル］イミダゾ［１，５－ａ］－ピラジン－１－イル｝Ｎ－（ピリジン－２－イル）－ベンズアミドの調製のためのプロセス

Also Published As

Publication number Publication date
AU2021291437A1 (en) 2023-02-16
DOP2022000287A (es) 2023-03-15
AU2024204906A1 (en) 2024-08-01
TW202200145A (zh) 2022-01-01
CN115916161A (zh) 2023-04-04
US20230226049A1 (en) 2023-07-20
JP2023531606A (ja) 2023-07-25
AU2021291437B2 (en) 2024-07-04
PE20230992A1 (es) 2023-06-23
MX2022016341A (es) 2023-01-24
IL298872A (en) 2023-02-01
AR122681A1 (es) 2022-09-28
BR112022025611A2 (pt) 2023-01-03
EP4167968A1 (en) 2023-04-26
CL2022003620A1 (es) 2023-05-05
CA3186141A1 (en) 2021-12-23
KR20230027201A (ko) 2023-02-27
CR20230018A (es) 2023-04-11
WO2021255246A1 (en) 2021-12-23
UY39288A (es) 2022-01-31

Similar Documents

Publication Publication Date Title
CO2023000536A2 (es) Formas farmacéuticas de maleato de acalabrutinib
CL2017002636A1 (es) Composiciones que comprenden una combinación de un anticuerpo anti muerte programada 1 (pd-1) y otro anticuerpo.
CL2017000080A1 (es) Métodos para tratar el cáncer con inhibidores de tigit y agentes contra el cáncer
CL2017002792A1 (es) Derivados de ciclohexano sustituido con amido
CO2020014217A2 (es) Moduladores de enzimas modificadoras de metilo, composiciones y usos de estos
CL2015001891A1 (es) Formas de dosis de liberación controlada encerradas resistentes a manipulaciones indebidas; uso para tratar el dolor; y metodo de preparacion. (divisional de la solicitud n°2754-2014).
PE20191474A1 (es) Compuestos de amino-triazolopiridina y su uso en el tratamiento del cancer
CO2021010490A2 (es) Compuestos, composiciones y métodos
CL2022001743A1 (es) Dosis de gamma-hidroxibutirato (ghb)
AR109263A2 (es) Composición que comprende moxidectina
CR7583A (es) Nueva sal formiato de o-desmetil venlafaxina
DOP2023000150A (es) Conjugados de fármaco-anticuerpo activable anti-cd71 y métodos de uso de estos
CL2022002564A1 (es) Combinaciones de brimonidina de dosis baja y usos de las mismas. (solicitud divisional de 201903572)
CL2021000924A1 (es) Uso de reboxetina para el tratamiento de narcolepsia
CL2019001749A1 (es) Uso de anticuerpos anti-esclerostina en el tratamiento de osteogenesis imperfecta.
CO2024000890A2 (es) Compuestos de heteroarilo para tratar la enfermedad de huntington
CR20160037A (es) Formas de dosificación farmacéuticas estabilizadas que comprenden atrasentán
PA8651401A1 (es) Formas de dosificacion oral solidas que contienen una dosis baja de estradiol
ECSP22021881A (es) Composición farmacéutica acuosa de anticuerpo anti-pd1 prolgolimab y su uso
AR117405A1 (es) Uso de conjugados anticuerpo-fármaco que comprenden agentes que alteran la tubulina para tratar tumores sólidos
AR125815A1 (es) Composiciones farmacéuticas que comprenden anticuerpos biespecíficos que se unen a b7h4 y cd3
ECSP24007729A (es) Compuestos de heteroarilo para tratar la enfermedad de huntington
EA201891739A1 (ru) ПРИМЕНЕНИЕ СТИМУЛЯТОРОВ sGC ДЛЯ ЛЕЧЕНИЯ НЕАЛКОГОЛЬНОГО СТЕАТОГЕПАТИТА (NASH)
MX2023011498A (es) Toallita topica que contiene nifedipina y lidocaina.
DOP2023000103A (es) Composición fungicida