BR112023015272A2 - Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas - Google Patents

Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas

Info

Publication number
BR112023015272A2
BR112023015272A2 BR112023015272A BR112023015272A BR112023015272A2 BR 112023015272 A2 BR112023015272 A2 BR 112023015272A2 BR 112023015272 A BR112023015272 A BR 112023015272A BR 112023015272 A BR112023015272 A BR 112023015272A BR 112023015272 A2 BR112023015272 A2 BR 112023015272A2
Authority
BR
Brazil
Prior art keywords
centanafadine
pharmaceutical formulations
methods
manufacture
ctn
Prior art date
Application number
BR112023015272A
Other languages
English (en)
Inventor
Kai Suzuki
Masahiro Hasegawa
Kumar Mididoddi Praveen
Salin Gupta
Shailly Mehrotra
Elizabeth Shoaf Susan
Asfar Mateen Syed
Original Assignee
Otsuka Pharma Co Ltd
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 Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of BR112023015272A2 publication Critical patent/BR112023015272A2/pt

Links

Classifications

    • 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
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K9/1635Organic 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
    • A61K9/1605Excipients; 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine

Landscapes

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

Abstract

formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas. a presente invenção refere-se a formulações farmacêuticas contendo centanafadina (ctn) ou um sal farmaceuticamente aceitável da mesma e um excipiente e métodos de fabricação e uso relacionados.
BR112023015272A 2021-02-23 2022-02-22 Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas BR112023015272A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163152826P 2021-02-23 2021-02-23
US202163241839P 2021-09-08 2021-09-08
PCT/JP2022/007314 WO2022181625A1 (en) 2021-02-23 2022-02-22 Centanafadine pharmaceutical formulations, and methods of making and using same

Publications (1)

Publication Number Publication Date
BR112023015272A2 true BR112023015272A2 (pt) 2023-11-07

Family

ID=80735736

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112023015272A BR112023015272A2 (pt) 2021-02-23 2022-02-22 Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas

Country Status (11)

Country Link
US (4) US11564885B2 (pt)
EP (1) EP4297734A1 (pt)
JP (1) JP2024506595A (pt)
KR (1) KR20230152046A (pt)
AU (1) AU2022227367A1 (pt)
BR (1) BR112023015272A2 (pt)
CA (1) CA3205786A1 (pt)
IL (1) IL303767A (pt)
MX (1) MX2023009833A (pt)
TW (1) TW202302086A (pt)
WO (1) WO2022181625A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022181625A1 (en) * 2021-02-23 2022-09-01 Otsuka Pharmaceutical Co., Ltd. Centanafadine pharmaceutical formulations, and methods of making and using same
WO2024043260A1 (en) * 2022-08-24 2024-02-29 Otsuka Pharmaceutical Co., Ltd. Pharmaceutical composition comprising centanafadine
WO2024048782A1 (en) * 2022-09-02 2024-03-07 Otsuka Pharmaceutical Co., Ltd. 1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane for treating major depressive disorder

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2809918A (en) 1955-10-17 1957-10-15 Victor M Hermelin Sustained release pharmaceutical preparations
DE2010416B2 (de) 1970-03-05 1979-03-29 Hoechst Ag, 6000 Frankfurt Oral anwendbare Arzneiform mit Retardwirkung
FR2471186A1 (fr) 1979-12-10 1981-06-19 Roussel Uclaf Nouveaux comprimes a delitescence colique, ainsi que leur procede de preparation
US4728512A (en) 1985-05-06 1988-03-01 American Home Products Corporation Formulations providing three distinct releases
US4794001A (en) 1986-03-04 1988-12-27 American Home Products Corporation Formulations providing three distinct releases
US5225202A (en) 1991-09-30 1993-07-06 E. R. Squibb & Sons, Inc. Enteric coated pharmaceutical compositions
GB9416600D0 (en) * 1994-08-17 1994-10-12 Smithkline Beecham Plc Pharmaceutical formulation
US6132724A (en) 1998-04-29 2000-10-17 City Of Hope National Medical Center Allelic polygene diagnosis of reward deficiency syndrome and treatment
US8747895B2 (en) * 2004-09-13 2014-06-10 Aptalis Pharmatech, Inc. Orally disintegrating tablets of atomoxetine
CA2659215C (en) 2005-07-27 2018-07-10 Dov Pharmaceutical, Inc. Novel 1-aryl-3-azabicyclo[3.1.0]hexanes: preparation and use to treat neuropsychiatric disorders
EP2023900B1 (en) * 2006-05-12 2014-12-24 Shire LLC Controlled dose drug delivery system
US8846100B2 (en) * 2006-05-12 2014-09-30 Shire Llc Controlled dose drug delivery system
US20140206740A1 (en) * 2011-07-30 2014-07-24 Neurovance, Inc. Use Of (1R,5S)-(+)-(Napthalen-2-yl)-3-Azabicyclo[3.1.0]Hexane In The Treatment Of Conditions Affected By Monoamine Neurotransmitters
US20160303077A1 (en) 2013-12-09 2016-10-20 Neurovance, Inc. Novel compositions
EP3069715A1 (en) * 2015-03-20 2016-09-21 Salmon Pharma GmbH Immediate release dosage forms of Atomoxetine
US20180008575A1 (en) 2016-07-11 2018-01-11 Neurovance, Inc. Methods of treating binge eating disorder
WO2022181625A1 (en) * 2021-02-23 2022-09-01 Otsuka Pharmaceutical Co., Ltd. Centanafadine pharmaceutical formulations, and methods of making and using same

Also Published As

Publication number Publication date
EP4297734A1 (en) 2024-01-03
US20220265557A1 (en) 2022-08-25
US20240165030A1 (en) 2024-05-23
US20230338293A1 (en) 2023-10-26
MX2023009833A (es) 2023-09-04
US11759426B2 (en) 2023-09-19
US11564885B2 (en) 2023-01-31
KR20230152046A (ko) 2023-11-02
CA3205786A1 (en) 2022-09-01
IL303767A (en) 2023-08-01
AU2022227367A1 (en) 2023-08-03
JP2024506595A (ja) 2024-02-14
US20230104529A1 (en) 2023-04-06
US11980690B2 (en) 2024-05-14
TW202302086A (zh) 2023-01-16
WO2022181625A1 (en) 2022-09-01

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