AR123018A1 - Formulaciones del esteroide c21-n-pirazolilo 19-nor c3,3-disustituido y métodos de uso de este - Google Patents

Formulaciones del esteroide c21-n-pirazolilo 19-nor c3,3-disustituido y métodos de uso de este

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Publication number
AR123018A1
AR123018A1 ARP210102037A ARP210102037A AR123018A1 AR 123018 A1 AR123018 A1 AR 123018A1 AR P210102037 A ARP210102037 A AR P210102037A AR P210102037 A ARP210102037 A AR P210102037A AR 123018 A1 AR123018 A1 AR 123018A1
Authority
AR
Argentina
Prior art keywords
formula
compound
disubstituted
steroid
pyrazolyl
Prior art date
Application number
ARP210102037A
Other languages
English (en)
Inventor
Paul Steven Watson
Bret Berner
Padma Narayan
Xiaoxia Chen
Todd Anthony Stutzman
Raj Ramnik Jain
Jianing Meng
Carolyn Wilkerson
Original Assignee
Sage Therapeutics Inc
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 Sage Therapeutics Inc filed Critical Sage Therapeutics Inc
Publication of AR123018A1 publication Critical patent/AR123018A1/es

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/14—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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J43/00—Normal steroids having a nitrogen-containing hetero ring spiro-condensed or not condensed with the cyclopenta(a)hydrophenanthrene skeleton
    • C07J43/003—Normal steroids having a nitrogen-containing hetero ring spiro-condensed or not condensed with the cyclopenta(a)hydrophenanthrene skeleton not condensed
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Anesthesiology (AREA)

Abstract

Esta invención se relaciona con un esteroide C21-pirazolilo 19-nor C3,3-disustituido de fórmula (1) y composiciones farmacéuticas de este. También se divulgan en el presente documento para preparar las composiciones farmacéuticas del esteroide C21-pirazolilo 19-nor C3,3-disustituido de fórmula (1) y métodos de uso del esteroide C21-pirazolilo 19-nor C3,3-disustituido de fórmula (1) o formas sólidas cristalinas, sales farmacéuticamente aceptables y composiciones farmacéuticamente aceptables de este. Reivindicación 111: Un proceso para hacer una composición farmacéutica que comprende lo siguiente: (a) micronizar una forma cristalina del compuesto de la fórmula (1) para obtener una forma cristalina micronizada del compuesto de la fórmula (1), caracterizado por que la forma cristalina micronizada del compuesto de la fórmula (1) tiene una distribución de tamaño de partícula que se define por un D₉₀ de aproximadamente 1 mm a aproximadamente 100 mm; (b) mezclar la forma cristalina micronizada del compuesto de la fórmula (1) con uno o más excipientes farmacéuticamente aceptables para producir una mezcla; (c) granular la mezcla para producir gránulos; (d) moler los gránulos para producir una fase intragranular; y (e) mezclar la fase intragranular con uno o más excipientes farmacéuticos extragranulares para producir la composición farmacéutica. Reivindicación 115: El proceso de cualquiera de las reivindicaciones 111 - 113, caracterizado por que, en el paso (b), el compuesto cristalino micronizado de la fórmula (1) se mezcla con un relleno, un disgregante, un lubricante y un deslizante. Reivindicación 116: El proceso de la reivindicación 113 ó 115, caracterizado por que, en el paso (b), el relleno se selecciona del grupo que consiste en un relleno frágil, un relleno dúctil y combinaciones de estos.
ARP210102037A 2020-07-20 2021-07-20 Formulaciones del esteroide c21-n-pirazolilo 19-nor c3,3-disustituido y métodos de uso de este AR123018A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202063054070P 2020-07-20 2020-07-20

Publications (1)

Publication Number Publication Date
AR123018A1 true AR123018A1 (es) 2022-10-26

Family

ID=77265332

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP210102037A AR123018A1 (es) 2020-07-20 2021-07-20 Formulaciones del esteroide c21-n-pirazolilo 19-nor c3,3-disustituido y métodos de uso de este

Country Status (18)

Country Link
US (2) US20230285417A1 (es)
EP (1) EP4181884A1 (es)
JP (1) JP2023537240A (es)
KR (1) KR20230041049A (es)
CN (1) CN116367827A (es)
AR (1) AR123018A1 (es)
AU (1) AU2021312240A1 (es)
BR (1) BR112023000990A2 (es)
CA (1) CA3187178A1 (es)
CL (2) CL2023000176A1 (es)
CO (1) CO2023001579A2 (es)
EC (1) ECSP23012042A (es)
IL (1) IL299829A (es)
JO (1) JOP20220351A1 (es)
MX (1) MX2023000835A (es)
PE (1) PE20231301A1 (es)
TW (1) TW202220667A (es)
WO (1) WO2022020363A1 (es)

Families Citing this family (14)

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EP2806877B2 (en) 2012-01-23 2025-01-29 Sage Therapeutics, Inc. Neuroactive steroid formulations comprising a complex of allopregnanolone and sulfobutyl ether beta-cyclodextrin
CA2882708A1 (en) 2012-08-21 2014-02-27 Sage Therapeutics, Inc. Methods of treating epilepsy or status epilepticus
KR102396328B1 (ko) 2013-04-17 2022-05-10 세이지 테라퓨틱스, 인크. 19-노르 c3,3-이치환된 c21-n-피라졸릴 스테로이드 및 그의 사용 방법
US10246482B2 (en) 2014-06-18 2019-04-02 Sage Therapeutics, Inc. Neuroactive steroids, compositions, and uses thereof
JOP20200195A1 (ar) 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
WO2016082789A1 (en) 2014-11-27 2016-06-02 Sage Therapeutics, Inc. Compositions and methods for treating cns disorders
EP3504189A1 (en) 2016-08-23 2019-07-03 Sage Therapeutics, Inc. A crystalline 19-nor c3, 3-disubstituted c21-n-pyrazolyl steroid
MA51046A (fr) 2017-12-08 2021-03-17 Sage Therapeutics Inc Dérivés de 21-[4-cyano-pyrazol-1-yl]-19-nor-pregan-3. alpha-ol-20-one deutérés pour le traitement de troubles du snc
US20240245711A1 (en) 2021-03-17 2024-07-25 Sage Therapeutics, Inc. A 19-nor c3,3-disubstituted c21-n-pyrazolyl steroid for the treatment of major depressive disorder
WO2022232504A1 (en) 2021-04-29 2022-11-03 Sage Therapeutics, Inc. 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid for use in treating major depressive disorder and postpartum depression
EP4329769A1 (en) 2021-04-29 2024-03-06 Sage Therapeutics, Inc. Neuroactive steroid for use in treating major depressive disorder and postpartum depression in a lactating female
IL315023A (en) 2022-02-16 2024-10-01 Sage Therapeutics Inc Neuroactive steroids for treatment of cns-related disorders
WO2023163879A1 (en) 2022-02-28 2023-08-31 Sage Therapeutics, Inc. Neuroactive steroids for treatment of gastrointestinal diseases or conditions
WO2026055127A2 (en) 2024-09-04 2026-03-12 Sage Therapeutics, Inc., A Wholly Owned Subsidiary Of Supernus Pharmaceuticals, Inc. Process for producing a gaba receptor modulator

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3635B1 (ar) * 2009-05-18 2020-08-27 Millennium Pharm Inc مركبات صيدلانية صلبة وطرق لانتاجها
KR102396328B1 (ko) * 2013-04-17 2022-05-10 세이지 테라퓨틱스, 인크. 19-노르 c3,3-이치환된 c21-n-피라졸릴 스테로이드 및 그의 사용 방법
US9725481B2 (en) 2013-04-17 2017-08-08 Sage Therapeutics, Inc. 19-nor C3, 3-disubstituted C21-C-bound heteroaryl steroids and methods of use thereof
EP3504189A1 (en) * 2016-08-23 2019-07-03 Sage Therapeutics, Inc. A crystalline 19-nor c3, 3-disubstituted c21-n-pyrazolyl steroid
EP3612186A1 (en) * 2017-04-18 2020-02-26 Marinus Pharmaceuticals, Inc. Sustained release injectable neurosteroid formulations
WO2019051264A1 (en) * 2017-09-07 2019-03-14 Sage Therapeutics, Inc. NEUROACTIVE STEROIDS AND METHODS OF USE
CA3103421A1 (en) * 2018-06-12 2019-12-19 Sage Therapeutics, Inc. A 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid and methods of use thereof

Also Published As

Publication number Publication date
AU2021312240A1 (en) 2023-02-02
CA3187178A1 (en) 2022-01-27
BR112023000990A2 (pt) 2023-03-28
US20230057130A1 (en) 2023-02-23
KR20230041049A (ko) 2023-03-23
CO2023001579A2 (es) 2023-03-07
CL2023000176A1 (es) 2023-09-15
JP2023537240A (ja) 2023-08-31
US20230285417A1 (en) 2023-09-14
WO2022020363A9 (en) 2023-02-09
TW202220667A (zh) 2022-06-01
EP4181884A1 (en) 2023-05-24
WO2022020363A1 (en) 2022-01-27
PE20231301A1 (es) 2023-08-24
IL299829A (en) 2023-03-01
JOP20220351A1 (ar) 2022-12-27
MX2023000835A (es) 2023-04-10
CL2024000627A1 (es) 2024-09-13
CN116367827A (zh) 2023-06-30
ECSP23012042A (es) 2023-03-31

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