MX2022016341A - Formas farmaceuticas de maleato de acalabrutinib. - Google Patents

Formas farmaceuticas de maleato de acalabrutinib.

Info

Publication number
MX2022016341A
MX2022016341A MX2022016341A MX2022016341A MX2022016341A MX 2022016341 A MX2022016341 A MX 2022016341A MX 2022016341 A MX2022016341 A MX 2022016341A MX 2022016341 A MX2022016341 A MX 2022016341A MX 2022016341 A MX2022016341 A MX 2022016341A
Authority
MX
Mexico
Prior art keywords
dosage forms
pharmaceutical dosage
acalabrutinib
methods
maleate
Prior art date
Application number
MX2022016341A
Other languages
English (en)
Inventor
Michael Golden
Andrew Robbins
Paul Bethel
John Blyth
Steve Cosgrove
James Mann
Xavier Jacques Henri Pepin
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 MX2022016341A publication Critical patent/MX2022016341A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic 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.
MX2022016341A 2020-06-19 2021-06-18 Formas farmaceuticas de maleato de acalabrutinib. MX2022016341A (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
MX2022016341A true MX2022016341A (es) 2023-01-24

Family

ID=76829497

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022016341A MX2022016341A (es) 2020-06-19 2021-06-18 Formas farmaceuticas 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
DK2498756T4 (da) * 2009-11-09 2023-03-20 Wyeth Llc Tabletformuleringer af neratinibmaleat
UA115312C2 (uk) 2011-07-19 2017-10-25 Мерк Шарп І Доум Б.В. 4-імідазопіридазин-1-ілбензаміди і 4-імідазотриазин-1-ілбензаміди як втк-інгібітори
EP2572703A1 (en) * 2011-09-21 2013-03-27 Hexal AG Compressed oral dosage form for asenapine maleate
LT3302565T (lt) * 2015-06-04 2019-12-27 Pfizer Inc. Kietos palbociklibo dozavimo formos
SI3954690T1 (sl) * 2015-07-02 2023-07-31 Acerta Pharma B.V. Trdne oblike in formulacije (S)-4-(8-amino-3-(1-(but-2-inoil)pirolidin-2-il)imidazo(1,5-a)pirazin- 1-il)-N-(piridin-2-il)benzamida
WO2018148961A1 (zh) * 2017-02-20 2018-08-23 杭州领业医药科技有限公司 Acp-196盐的晶型、其制备方法、药物组合物和用途
CN112638878A (zh) 2018-08-29 2021-04-09 安塞塔制药公司 制备4-{8-氨基-3-[(2S)-1-(丁-2-炔酰基)-吡咯烷-2-基]咪唑并[1,5-a]-吡嗪-1-基}N-(吡啶-2-基)-苯甲酰胺的方法

Also Published As

Publication number Publication date
AU2021291437A1 (en) 2023-02-16
AU2021291437B2 (en) 2024-07-04
AU2024204906A1 (en) 2024-08-01
UY39288A (es) 2022-01-31
AR122681A1 (es) 2022-09-28
TW202200145A (zh) 2022-01-01
PE20230992A1 (es) 2023-06-23
IL298872A (en) 2023-02-01
WO2021255246A1 (en) 2021-12-23
CO2023000536A2 (es) 2023-01-26
DOP2022000287A (es) 2023-03-15
CR20230018A (es) 2023-04-11
EP4167968A1 (en) 2023-04-26
CL2022003620A1 (es) 2023-05-05
US20230226049A1 (en) 2023-07-20
JP2023531606A (ja) 2023-07-25
CN115916161A (zh) 2023-04-04
KR20230027201A (ko) 2023-02-27
CA3186141A1 (en) 2021-12-23
BR112022025611A2 (pt) 2023-01-03

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