AU2022227367A1 - Centanafadine pharmaceutical formulations, and methods of making and using same - Google Patents

Centanafadine pharmaceutical formulations, and methods of making and using same Download PDF

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Publication number
AU2022227367A1
AU2022227367A1 AU2022227367A AU2022227367A AU2022227367A1 AU 2022227367 A1 AU2022227367 A1 AU 2022227367A1 AU 2022227367 A AU2022227367 A AU 2022227367A AU 2022227367 A AU2022227367 A AU 2022227367A AU 2022227367 A1 AU2022227367 A1 AU 2022227367A1
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AU
Australia
Prior art keywords
beads
ctn
range
pharmaceutical formulation
formulation
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
AU2022227367A
Other languages
English (en)
Other versions
AU2022227367A9 (en
Inventor
Salin Gupta
Masahiro Hasegawa
Syed Asfar Mateen
Shailly Mehrotra
Praveen Kumar Mididoddi
Susan Elizabeth Shoaf
Kai Suzuki
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Otsuka Pharmaceutical Co Ltd
Original Assignee
Otsuka Pharmaceutical 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 Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Publication of AU2022227367A1 publication Critical patent/AU2022227367A1/en
Publication of AU2022227367A9 publication Critical patent/AU2022227367A9/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic 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
    • A61K31/403—Heterocyclic 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
    • 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
    • A61K9/167—Agglomerates; 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
    • 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
    • A61K9/50—Microcapsules 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
    • A61K9/5084—Mixtures 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
    • 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
    • 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
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
AU2022227367A 2021-02-23 2022-02-22 Centanafadine pharmaceutical formulations, and methods of making and using same Pending AU2022227367A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163152826P 2021-02-23 2021-02-23
US63/152,826 2021-02-23
US202163241839P 2021-09-08 2021-09-08
US63/241,839 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 (2)

Publication Number Publication Date
AU2022227367A1 true AU2022227367A1 (en) 2023-08-03
AU2022227367A9 AU2022227367A9 (en) 2024-10-17

Family

ID=80735736

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2022227367A Pending AU2022227367A1 (en) 2021-02-23 2022-02-22 Centanafadine pharmaceutical formulations, and methods of making and using same

Country Status (11)

Country Link
US (6) US11564885B2 (enExample)
EP (1) EP4297734A1 (enExample)
JP (2) JP7787190B2 (enExample)
KR (1) KR20230152046A (enExample)
AU (1) AU2022227367A1 (enExample)
BR (1) BR112023015272A2 (enExample)
CA (1) CA3205786A1 (enExample)
IL (1) IL303767A (enExample)
MX (1) MX2023009833A (enExample)
TW (1) TW202302086A (enExample)
WO (1) WO2022181625A1 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112023015272A2 (pt) * 2021-02-23 2023-11-07 Otsuka Pharma Co Ltd Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas
KR20250053128A (ko) * 2022-08-24 2025-04-21 오츠카 세이야쿠 가부시키가이샤 센타나파딘을 포함하는 제약 조성물
US20250375418A1 (en) * 2022-09-02 2025-12-11 Otsuka Pharmaceutical Co., Ltd. 1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane for treating major depressive disorder
WO2025183181A1 (en) 2024-02-28 2025-09-04 Otsuka Pharmaceutical Co., Ltd. Use of centanafadine in treatment of adhd symptoms
US12502358B1 (en) 2024-08-13 2025-12-23 Innovate Therapeutics Llc Centanafadine multiphasic controlled-release pharmaceutical formulation
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Family Cites Families (19)

* 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
WO2006133349A2 (en) 2005-06-08 2006-12-14 Alpharma, Inc. Orally disintegrable sleep aid formulations
EP1915146A4 (en) * 2005-07-27 2010-06-02 Dov Pharmaceutical Inc NOVEL 1-ARYL-3-AZABICYCLO [3.1.0] HEXANEES. PREPARATION AND USE FOR THE TREATMENT OF NEUROPSYCHIATRIC DISEASES
ES2529455T3 (es) * 2006-05-12 2015-02-20 Shire Llc Sistema de administración de fármacos por dosis controladas
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
CN107335057A (zh) 2012-07-27 2017-11-10 韦尔斯利医药有限公司 用于缓解尿频的药物制剂及其使用方法
CN106029637A (zh) 2013-12-09 2016-10-12 纽罗万斯公司 新的组合物
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
BR112023015272A2 (pt) * 2021-02-23 2023-11-07 Otsuka Pharma Co Ltd Formulações farmacêuticas de centanafadina e métodos de fabricação e uso das mesmas

Also Published As

Publication number Publication date
US20250041225A1 (en) 2025-02-06
US11564885B2 (en) 2023-01-31
US20230338293A1 (en) 2023-10-26
JP7787190B2 (ja) 2025-12-16
MX2023009833A (es) 2023-09-04
TW202302086A (zh) 2023-01-16
US20240165030A1 (en) 2024-05-23
JP2024506595A (ja) 2024-02-14
EP4297734A1 (en) 2024-01-03
US11980690B2 (en) 2024-05-14
US12156941B2 (en) 2024-12-03
AU2022227367A9 (en) 2024-10-17
US11759426B2 (en) 2023-09-19
IL303767A (en) 2023-08-01
JP2025183214A (ja) 2025-12-16
US20250319030A1 (en) 2025-10-16
US20220265557A1 (en) 2022-08-25
BR112023015272A2 (pt) 2023-11-07
CA3205786A1 (en) 2022-09-01
WO2022181625A1 (en) 2022-09-01
US12370144B2 (en) 2025-07-29
US20230104529A1 (en) 2023-04-06
KR20230152046A (ko) 2023-11-02

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