PE20230830A1 - Formulaciones farmaceuticas de acetato de abiraterona y niraparib - Google Patents

Formulaciones farmaceuticas de acetato de abiraterona y niraparib

Info

Publication number
PE20230830A1
PE20230830A1 PE2022002554A PE2022002554A PE20230830A1 PE 20230830 A1 PE20230830 A1 PE 20230830A1 PE 2022002554 A PE2022002554 A PE 2022002554A PE 2022002554 A PE2022002554 A PE 2022002554A PE 20230830 A1 PE20230830 A1 PE 20230830A1
Authority
PE
Peru
Prior art keywords
abiraterone acetate
niraparib
pharmaceutical formulations
composition
glidant
Prior art date
Application number
PE2022002554A
Other languages
English (en)
Inventor
Thomas Ronald A Quinten
Urbain Alfons C Delaet
Philip Erna H Heyns
Tatiana Marcozzi
Johny Bertels
Katrien Luyten
Kaustubh Ramesh Tambwekar
Angela Lopez-Gitlitz
Kok Paul J A Hartman
Original Assignee
Janssen Pharmaceutica Nv
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 Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of PE20230830A1 publication Critical patent/PE20230830A1/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/25Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • 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
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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

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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Oncology (AREA)
  • Reproductive Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Epoxy Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Referido a una composicion en granulos que comprende acetato de abiraterona, monohidrato de tosilato de niraparib y un transportador farmaceuticamente aceptable; en donde el citado transportador comprende un agente humectante, un diluyente, un disgregante; opcionalmente un deslizante, lubricante y aglutinante. Dichos granulos tienen una distribucion del tamano de particula con un d50 de aproximadamente 200 a aproximadamente 500 µm. Tambien se refiere a una forma de dosificacion oral de dicha composicion en granulos y un proceso de preparacion; siendo util en tratamiento de una enfermedad o afeccion relacionada con el receptor de androgenos (AR), en particular el cancer, mas en particular el cancer de prostata
PE2022002554A 2020-05-08 2021-05-07 Formulaciones farmaceuticas de acetato de abiraterona y niraparib PE20230830A1 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP20173749 2020-05-08
US202163142919P 2021-01-28 2021-01-28
US202163174282P 2021-04-13 2021-04-13
PCT/EP2021/062188 WO2021224471A1 (en) 2020-05-08 2021-05-07 Pharmaceutical formulations of abiraterone acetate and niraparib

Publications (1)

Publication Number Publication Date
PE20230830A1 true PE20230830A1 (es) 2023-05-19

Family

ID=75888052

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2022002554A PE20230830A1 (es) 2020-05-08 2021-05-07 Formulaciones farmaceuticas de acetato de abiraterona y niraparib

Country Status (16)

Country Link
US (3) US20230226080A1 (es)
EP (3) EP4146209A1 (es)
JP (3) JP2023524794A (es)
KR (3) KR20230008780A (es)
CN (3) CN115515584A (es)
AU (3) AU2021267146A1 (es)
BR (3) BR112022021732A2 (es)
CA (3) CA3177137A1 (es)
CR (1) CR20220588A (es)
EC (1) ECSP22085983A (es)
IL (3) IL297990A (es)
MX (3) MX2022014004A (es)
PE (1) PE20230830A1 (es)
TW (3) TW202207925A (es)
UY (3) UY39203A (es)
WO (3) WO2021224471A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023148345A1 (en) * 2022-02-04 2023-08-10 Janssen Pharmaceutica Nv Niraparib and abiraterone acetate plus prednisone to improve clinical outcomes in patients with metastatic castration-resistant prostate cancer and hrr alterations

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK0633893T3 (da) 1992-03-31 2000-04-17 Btg Int Ltd 17-Substituerede steroider, der er nyttige ved cancerbehandling
SI2805945T1 (sl) 2007-01-10 2019-09-30 Msd Italia S.R.L. Amid substituirani indazoli, kot inhibitorji poli(ADP-riboza)polimeraze(PARP)
RU2495035C2 (ru) 2008-01-08 2013-10-10 Мерк Шарп Энд Домэ Лтд Фармацевтически приемлемые соли 2-{4-[(3s)-пиперидин-3-ил]фенил}-2н-индазол-7-карбоксамида
CN102743393A (zh) * 2012-07-27 2012-10-24 海南盛科生命科学研究院 一种含有醋酸阿比特龙的药物组合物及制备工艺
WO2015032873A1 (en) * 2013-09-06 2015-03-12 Synthon B.V. High-load pharmaceutical compositions comprising abiraterone acetate
WO2016001208A1 (en) * 2014-06-30 2016-01-07 Galenicum Health S.L. Stable pharmaceutical compositions in the form of immediate release tablets
TN2018000318A1 (en) * 2014-09-18 2020-01-16 Iceutica Inc Abiraterone acetate formulation and methods of use.
BR112019020211A2 (pt) 2017-03-27 2020-04-22 Tesaro Inc composições de niraparib
JOP20190244A1 (ar) * 2017-04-13 2019-10-13 Janssen Pharmaceutica Nv تركيبة علاجية لسرطان البروستاتا
CA3076907A1 (en) * 2017-09-26 2019-04-04 Tesaro, Inc. Niraparib formulations
BR112020007090A2 (pt) * 2017-10-11 2020-09-24 Janssen Oncology, Inc. métodos de tratamento de câncer de próstata mediante a administração de acetato de abiraterona mais prednisona com terapia de supressão androgênica
WO2019206472A1 (en) * 2018-04-26 2019-10-31 Synthon B.V. Tablet compositions comprising abiraterone acetate
ES2967517T3 (es) 2018-10-03 2024-04-30 Tesaro Inc Sales de niraparib

Also Published As

Publication number Publication date
IL297990A (en) 2023-01-01
IL297984A (en) 2023-01-01
TW202211921A (zh) 2022-04-01
US20230226080A1 (en) 2023-07-20
EP4146210A1 (en) 2023-03-15
TW202207925A (zh) 2022-03-01
CR20220588A (es) 2023-01-17
KR20230008782A (ko) 2023-01-16
US20230226081A1 (en) 2023-07-20
CA3177123A1 (en) 2021-11-11
BR112022022590A2 (pt) 2022-12-13
UY39203A (es) 2021-11-30
MX2022014005A (es) 2022-11-30
BR112022021732A2 (pt) 2022-12-06
KR20230008783A (ko) 2023-01-16
EP4146209A1 (en) 2023-03-15
BR112022022534A2 (pt) 2022-12-13
TW202207926A (zh) 2022-03-01
IL297991A (en) 2023-01-01
AU2021266409A1 (en) 2023-01-19
UY39204A (es) 2021-11-30
CA3177094A1 (en) 2021-11-11
WO2021224471A1 (en) 2021-11-11
WO2021224467A1 (en) 2021-11-11
JP2023525026A (ja) 2023-06-14
CA3177137A1 (en) 2021-11-11
CN115515583A (zh) 2022-12-23
AU2021267146A1 (en) 2023-01-19
MX2022014003A (es) 2022-11-30
JP2023524794A (ja) 2023-06-13
JP2023524808A (ja) 2023-06-13
EP4146211A1 (en) 2023-03-15
KR20230008780A (ko) 2023-01-16
UY39201A (es) 2021-11-30
ECSP22085983A (es) 2022-12-30
WO2021224469A1 (en) 2021-11-11
US20230218640A1 (en) 2023-07-13
CN115515584A (zh) 2022-12-23
CN115551506A (zh) 2022-12-30
AU2021269115A1 (en) 2023-01-19
MX2022014004A (es) 2022-11-30

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