MX386859B - Composiciones farmacéuticas sólidas de antagonistas de los receptores de andrógenos. - Google Patents

Composiciones farmacéuticas sólidas de antagonistas de los receptores de andrógenos.

Info

Publication number
MX386859B
MX386859B MX2016010216A MX2016010216A MX386859B MX 386859 B MX386859 B MX 386859B MX 2016010216 A MX2016010216 A MX 2016010216A MX 2016010216 A MX2016010216 A MX 2016010216A MX 386859 B MX386859 B MX 386859B
Authority
MX
Mexico
Prior art keywords
solid pharmaceutical
receptor antagonists
pharmaceutical compositions
androgen receptor
enzalutamide
Prior art date
Application number
MX2016010216A
Other languages
English (en)
Other versions
MX2016010216A (es
Inventor
Andrija Lebar
Bostjan Petek
Jerneja Opara
Klemen Naversnik
Petra Bozic
Petra Draksler
Rok Grahek
Original Assignee
Lek Pharmaceuticals
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 Lek Pharmaceuticals filed Critical Lek Pharmaceuticals
Publication of MX2016010216A publication Critical patent/MX2016010216A/es
Publication of MX386859B publication Critical patent/MX386859B/es

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    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • A61K31/41521,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41661,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • 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
    • A61K9/1611Inorganic compounds
    • 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
    • A61K9/1617Organic 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
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • 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
    • A61P35/00Antineoplastic agents

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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención pertenece al campo de la industria farmacéutica y se refiere a una composición farmacéutica sólida que comprende antagonistas de los receptores de andrógeno, por ejemplo, Enzalutamida o ARN-509, así como a procesos para la preparación de la misma. Las composiciones farmacéuticas sólidas son útiles en el tratamiento de cáncer de próstata.
MX2016010216A 2014-02-05 2015-02-04 Composiciones farmacéuticas sólidas de antagonistas de los receptores de andrógenos. MX386859B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14154047 2014-02-05
PCT/EP2015/052311 WO2015118015A1 (en) 2014-02-05 2015-02-04 Solid pharmaceutical compositions of androgen receptor antagonists

Publications (2)

Publication Number Publication Date
MX2016010216A MX2016010216A (es) 2016-11-15
MX386859B true MX386859B (es) 2025-03-19

Family

ID=50031275

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016010216A MX386859B (es) 2014-02-05 2015-02-04 Composiciones farmacéuticas sólidas de antagonistas de los receptores de andrógenos.

Country Status (10)

Country Link
US (2) US20160346207A1 (es)
EP (1) EP3102183A1 (es)
JP (2) JP6666254B2 (es)
KR (2) KR20200015830A (es)
CN (2) CN112402360A (es)
AU (1) AU2015215000B2 (es)
CA (1) CA2940984A1 (es)
EA (2) EA037895B1 (es)
MX (1) MX386859B (es)
WO (1) WO2015118015A1 (es)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2836424T3 (es) 2012-09-26 2021-06-25 Aragon Pharmaceuticals Inc Antiandrógenos para tratar el cáncer de próstata no metastásico y resistente a la castración
MX381829B (es) * 2014-12-05 2025-03-13 Aragon Pharmaceuticals Inc Composiciones anticancerígenas.
ES2839128T3 (es) * 2014-12-05 2021-07-05 Aragon Pharmaceuticals Inc Composiciones anticancerosas
RS66323B1 (sr) * 2014-12-05 2025-01-31 Aragon Pharmaceuticals Inc Sastavi protiv raka
UA124154C2 (uk) * 2016-06-03 2021-07-28 Арагон Фармасьютікалз, Інк. Протиракові композиції
US20190321363A1 (en) * 2016-06-20 2019-10-24 Dr. Reddy's Laboratories Limited Process for the preparation of elagolix sodium and its polymorph
CN110023297A (zh) * 2016-07-08 2019-07-16 詹森药业有限公司 作为雄性激素受体拮抗剂的取代的乙内酰脲和硫代己内酰脲衍生物
US20190209469A1 (en) * 2016-08-20 2019-07-11 Ftf Pharma Private Limited Pharmaceutical composition comprising an androgen receptor inhibitor
ES3018265T3 (en) 2017-04-28 2025-05-14 Astellas Pharma Inc Orally administrable enzalutamide-containing pharmaceutical composition
RU2020105102A (ru) * 2017-07-04 2021-08-04 Бдр Фармасьютикалз Интернэшнл Прайвит Лимитед Новая композиция пероральной лекарственной формы энзалутамида и способ ее получения
WO2019016747A1 (en) * 2017-07-20 2019-01-24 Dr. Reddy's Laboratories Limited AMORPHOUS SOLID DISPERSIONS OF APALUTAMIDE AND PROCESS FOR THEIR PREPARATION
WO2019030691A1 (en) * 2017-08-08 2019-02-14 Dr. Reddy’S Laboratories Limited EXTRUDED COMPOSITIONS OF ENZALUTAMIDE
CZ2018234A3 (cs) 2018-05-21 2019-12-04 Zentiva Ks Zvýšení rozpustnosti a biodostupnosti enzalutamidu
CN108815129A (zh) * 2018-07-12 2018-11-16 天津双硕医药科技有限公司 一种恩杂鲁胺纳米晶体口服固体药物组合物
CA3120999C (en) 2018-11-30 2025-04-01 Chemocentryx, Inc. Capsule formulations
EP3972569A1 (en) * 2019-05-23 2022-03-30 Helm AG Nanoparticles comprising enzalutamide
CA3152909A1 (en) 2019-10-03 2021-04-08 Synthon Bv Pharmaceutical composition comprising enzalutamide
EP3811932A1 (en) 2019-10-22 2021-04-28 Zentiva K.S. Dosage form of apalutamide
US20240207239A1 (en) * 2021-02-06 2024-06-27 Sunshine Lake Pharma Co., Ltd. Composition and preparation method therefor
WO2024127361A1 (en) 2022-12-16 2024-06-20 Ferring B.V. Enzalutamide nanocrystals, methods and compositions
WO2025052925A1 (ja) * 2023-09-08 2025-03-13 沢井製薬株式会社 エンザルタミド固体分散体及びその製造方法、並びにエンザルタミド含有製剤及びその製造方法
WO2025125565A1 (en) 2023-12-13 2025-06-19 Krka, D.D., Novo Mesto Tablet comprising enzalutamide
WO2026052846A1 (en) 2024-09-09 2026-03-12 Synthon B.V. Pharmaceutical formulation comprising apalutamide

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ20033456A3 (en) * 2001-06-22 2004-07-14 Pfizer Products Inc. Pharmaceutical compositions comprising adsorbates of amorphous drug
WO2007127010A2 (en) * 2006-03-29 2007-11-08 The Regents Of The University Of California Diarylthiohydantoin compounds
HUE037389T2 (hu) * 2010-02-16 2018-08-28 Aragon Pharmaceuticals Inc Androgén receptor modulátorok és alkalmazásaik
NZ740700A (en) * 2012-07-27 2019-07-26 Aragon Pharmaceuticals Inc Methods and compositions for determining resistance to androgen receptor therapy
EP4450130A3 (en) * 2012-09-11 2025-01-08 Medivation Prostate Therapeutics LLC Formulations of enzalutamide

Also Published As

Publication number Publication date
US20160346207A1 (en) 2016-12-01
EA201891397A1 (ru) 2019-03-29
AU2015215000A1 (en) 2016-09-15
MX2016010216A (es) 2016-11-15
JP2020090505A (ja) 2020-06-11
CN106102716A (zh) 2016-11-09
JP2017507928A (ja) 2017-03-23
WO2015118015A1 (en) 2015-08-13
CA2940984A1 (en) 2015-08-13
KR20200015830A (ko) 2020-02-12
CN112402360A (zh) 2021-02-26
JP6666254B2 (ja) 2020-03-13
AU2015215000B2 (en) 2017-10-19
EA037895B1 (ru) 2021-06-02
KR20160113294A (ko) 2016-09-28
EA201691568A1 (ru) 2017-01-30
US20200163882A1 (en) 2020-05-28
EP3102183A1 (en) 2016-12-14
JP6934932B2 (ja) 2021-09-15

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