PE20230859A1 - Formas de dosificacion oral solidas de combinacion de antagonistas de la hormona liberadora de gonadotropina - Google Patents

Formas de dosificacion oral solidas de combinacion de antagonistas de la hormona liberadora de gonadotropina

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Publication number
PE20230859A1
PE20230859A1 PE2022002787A PE2022002787A PE20230859A1 PE 20230859 A1 PE20230859 A1 PE 20230859A1 PE 2022002787 A PE2022002787 A PE 2022002787A PE 2022002787 A PE2022002787 A PE 2022002787A PE 20230859 A1 PE20230859 A1 PE 20230859A1
Authority
PE
Peru
Prior art keywords
dosage forms
solid oral
gonadotropin
releasing hormone
oral dosage
Prior art date
Application number
PE2022002787A
Other languages
English (en)
Inventor
David E Alonzo
Kathleen D Ullmer
Minli Xie
Original Assignee
Myovant Sciences Gmbh
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 Myovant Sciences Gmbh filed Critical Myovant Sciences Gmbh
Publication of PE20230859A1 publication Critical patent/PE20230859A1/es

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    • 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
    • A61K9/2072Pills, 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
    • 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • A61K9/2004Excipients; 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
    • 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
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/2893Tablet coating processes
    • 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

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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)

Abstract

Referido a formas de dosificacion oral solida de combinacion que comprende: alrededor de 18 % a 22 % p/p de N-(4-(1-(2,6-difluorobencil)-5-((dimetilamino)metil)-3-(6-metoxi-3-piridazinil)-2,4-dioxo-1,2,3,4-tetrahidrotieno[2,3-d]pirimidin-6-il)fenil)-N'-metoxiurea, particularmente alrededor de 40 mg, o una sal farmaceuticamente aceptable de esta; alrededor de 0,3 % a 0,7 % p/p de estradiol; alrededor de 0,1 % a 0,4 % p/p de acetato de noretindrona; alrededor de 24 % a 28 % p/p de manitol; alrededor de 2 % a 6 % p/p de un almidon seleccionado del grupo que consiste en glicolato de almidon de sodio, almidon pregelatinizado, y una combinacion de lo anterior; alrededor de 0,5 % a 3 % p/p de hidroxipropilcelulosa; alrededor de 0,5 % a 3 % p/p de estearato de magnesio; alrededor de 38 % a 42 % p/p de monohidrato de lactosa; y alrededor de 1 % y 5 % p/p de un recubrimiento de pelicula. Formas de dosificacion oral solidas de combinacion de antagonistas de la hormona liberadora de gonadotropina. Tambien se refiere a un proceso para preparar dicha forma de dosificacion.
PE2022002787A 2020-05-29 2021-05-27 Formas de dosificacion oral solidas de combinacion de antagonistas de la hormona liberadora de gonadotropina PE20230859A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063032469P 2020-05-29 2020-05-29
PCT/EP2021/064280 WO2021239917A1 (en) 2020-05-29 2021-05-27 Combination solid oral dosage forms of gonadotropin-releasing hormone antagonists

Publications (1)

Publication Number Publication Date
PE20230859A1 true PE20230859A1 (es) 2023-05-30

Family

ID=76305879

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2022002787A PE20230859A1 (es) 2020-05-29 2021-05-27 Formas de dosificacion oral solidas de combinacion de antagonistas de la hormona liberadora de gonadotropina

Country Status (17)

Country Link
US (1) US20230165800A1 (es)
EP (1) EP4157227A1 (es)
JP (1) JP2023528014A (es)
KR (1) KR20230028732A (es)
CN (1) CN115666531A (es)
AR (1) AR122175A1 (es)
AU (1) AU2021278303A1 (es)
BR (1) BR112022023937A2 (es)
CA (1) CA3185151A1 (es)
CL (1) CL2022003338A1 (es)
CO (1) CO2022019160A2 (es)
EC (1) ECSP22098275A (es)
IL (1) IL298587A (es)
MX (1) MX2022015003A (es)
PE (1) PE20230859A1 (es)
UY (1) UY39229A (es)
WO (1) WO2021239917A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT3518933T (pt) 2016-09-30 2022-05-10 Takeda Pharmaceuticals Co Métodos de tratamento de fibroides uterinos e endometriose
CN115068421B (zh) * 2022-08-03 2023-08-04 南昌大学 一种瑞卢戈利纳米混悬液及其制备方法和应用
CN115227648B (zh) * 2022-08-03 2023-09-29 南昌大学 一种瑞卢戈利固体自微乳及其制备方法和应用

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100360538C (zh) 2003-01-29 2008-01-09 武田药品工业株式会社 噻吩并嘧啶化合物及其用途
EP4119564A1 (en) 2012-09-28 2023-01-18 Takeda Pharmaceutical Company Limited Production method of thienopyrimidine derivative
EP4233847A1 (en) 2015-02-26 2023-08-30 Takeda Pharmaceutical Company Limited A tablet comprising a methoxyurea derivative and mannitol particles
JP7062673B2 (ja) 2016-09-30 2022-05-06 ミオバント サイエンシズ ゲーエムベーハー 前立腺がんの治療
PT3518933T (pt) 2016-09-30 2022-05-10 Takeda Pharmaceuticals Co Métodos de tratamento de fibroides uterinos e endometriose

Also Published As

Publication number Publication date
IL298587A (en) 2023-01-01
CN115666531A (zh) 2023-01-31
MX2022015003A (es) 2023-03-03
CA3185151A1 (en) 2021-12-02
CL2022003338A1 (es) 2023-06-30
UY39229A (es) 2021-12-31
BR112022023937A2 (pt) 2022-12-27
WO2021239917A1 (en) 2021-12-02
KR20230028732A (ko) 2023-03-02
EP4157227A1 (en) 2023-04-05
CO2022019160A2 (es) 2023-03-27
JP2023528014A (ja) 2023-07-03
ECSP22098275A (es) 2023-01-31
US20230165800A1 (en) 2023-06-01
AU2021278303A1 (en) 2023-02-09
AR122175A1 (es) 2022-08-24

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