AU2015350148B2 - Sublingual formulation of riluzole - Google Patents

Sublingual formulation of riluzole Download PDF

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Publication number
AU2015350148B2
AU2015350148B2 AU2015350148A AU2015350148A AU2015350148B2 AU 2015350148 B2 AU2015350148 B2 AU 2015350148B2 AU 2015350148 A AU2015350148 A AU 2015350148A AU 2015350148 A AU2015350148 A AU 2015350148A AU 2015350148 B2 AU2015350148 B2 AU 2015350148B2
Authority
AU
Australia
Prior art keywords
disorder
riluzole
use disorder
mild
sublingual
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.)
Active
Application number
AU2015350148A
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English (en)
Other versions
AU2015350148A1 (en
Inventor
Robert M. Berman
Vladimir Coric
Amgad SALEH
Ronald Samuel Vladyka
Danny Yu
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.)
Biohaven Pharmaceutical Holding Co Ltd
Original Assignee
Biohaven Pharmaceutical Holding 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 Biohaven Pharmaceutical Holding Co Ltd filed Critical Biohaven Pharmaceutical Holding Co Ltd
Publication of AU2015350148A1 publication Critical patent/AU2015350148A1/en
Application granted granted Critical
Publication of AU2015350148B2 publication Critical patent/AU2015350148B2/en
Priority to AU2021201034A priority Critical patent/AU2021201034B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2015350148A 2014-11-21 2015-11-17 Sublingual formulation of riluzole Active AU2015350148B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021201034A AU2021201034B2 (en) 2014-11-21 2021-02-17 Sublingual formulation of riluzole

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462083094P 2014-11-21 2014-11-21
US62/083,094 2014-11-21
PCT/US2015/061114 WO2016081472A1 (en) 2014-11-21 2015-11-17 Sublingual formulation of riluzole

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021201034A Division AU2021201034B2 (en) 2014-11-21 2021-02-17 Sublingual formulation of riluzole

Publications (2)

Publication Number Publication Date
AU2015350148A1 AU2015350148A1 (en) 2017-06-15
AU2015350148B2 true AU2015350148B2 (en) 2020-11-26

Family

ID=55085882

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2015350148A Active AU2015350148B2 (en) 2014-11-21 2015-11-17 Sublingual formulation of riluzole
AU2021201034A Active AU2021201034B2 (en) 2014-11-21 2021-02-17 Sublingual formulation of riluzole

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021201034A Active AU2021201034B2 (en) 2014-11-21 2021-02-17 Sublingual formulation of riluzole

Country Status (24)

Country Link
US (3) US11660267B2 (cg-RX-API-DMAC7.html)
EP (3) EP4039247B1 (cg-RX-API-DMAC7.html)
JP (3) JP6753860B2 (cg-RX-API-DMAC7.html)
KR (2) KR102580378B1 (cg-RX-API-DMAC7.html)
CN (1) CN107249567B (cg-RX-API-DMAC7.html)
AU (2) AU2015350148B2 (cg-RX-API-DMAC7.html)
BR (1) BR112017010423B1 (cg-RX-API-DMAC7.html)
CA (1) CA2967662A1 (cg-RX-API-DMAC7.html)
CY (1) CY1122469T1 (cg-RX-API-DMAC7.html)
DK (1) DK3220891T3 (cg-RX-API-DMAC7.html)
EA (1) EA038518B1 (cg-RX-API-DMAC7.html)
ES (2) ES2882783T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20191892T8 (cg-RX-API-DMAC7.html)
HU (1) HUE046869T2 (cg-RX-API-DMAC7.html)
IL (2) IL278188B2 (cg-RX-API-DMAC7.html)
LT (1) LT3220891T (cg-RX-API-DMAC7.html)
MX (1) MX368838B (cg-RX-API-DMAC7.html)
PH (1) PH12017500934B1 (cg-RX-API-DMAC7.html)
PL (1) PL3220891T3 (cg-RX-API-DMAC7.html)
PT (1) PT3220891T (cg-RX-API-DMAC7.html)
RS (1) RS59490B1 (cg-RX-API-DMAC7.html)
SG (1) SG11201703896QA (cg-RX-API-DMAC7.html)
SI (1) SI3220891T1 (cg-RX-API-DMAC7.html)
WO (1) WO2016081472A1 (cg-RX-API-DMAC7.html)

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AU2019322889A1 (en) * 2018-08-16 2021-03-04 Biohaven Therapeutics Ltd. Use of riluzole oral disintigrating tablets for treating diseases
US20210113557A1 (en) * 2019-10-22 2021-04-22 Arvinas Operations, Inc. Methods of treating prostate cancer
JP2023524599A (ja) 2020-05-09 2023-06-12 アルビナス・オペレーションズ・インコーポレイテッド 二官能性化合物を製造する方法、二官能性化合物の超高純度形態、及びそれらを含む剤形
US20240016783A1 (en) * 2020-10-05 2024-01-18 Icahn School Of Medicine At Mount Sinai Riluzole for the treatment of alzheimer's disease
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CN113876735B (zh) * 2021-10-20 2023-05-12 陇南市第一人民医院 一种利鲁唑微球制剂及其制备方法
KR102625977B1 (ko) 2021-11-24 2024-01-17 부산대학교 산학협력단 리루졸을 유효성분으로 포함하는 염증성 장질환 예방 또는 치료용 조성물
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Also Published As

Publication number Publication date
HUE046869T2 (hu) 2020-04-28
MX2017006446A (es) 2018-02-12
PH12017500934A1 (en) 2017-11-20
US20180153794A1 (en) 2018-06-07
CN107249567B (zh) 2021-08-03
RS59490B1 (sr) 2019-12-31
AU2021201034B2 (en) 2023-07-06
BR112017010423A2 (pt) 2017-12-26
US20250114301A1 (en) 2025-04-10
JP2021001173A (ja) 2021-01-07
US11660267B2 (en) 2023-05-30
HRP20191892T1 (hr) 2020-01-10
LT3220891T (lt) 2019-11-11
US12121609B2 (en) 2024-10-22
EP3616686B8 (en) 2021-06-23
EA201790958A1 (ru) 2018-01-31
IL278188B2 (en) 2025-03-01
EP3616686A1 (en) 2020-03-04
EP4039247A2 (en) 2022-08-10
SG11201703896QA (en) 2017-06-29
ES2882783T3 (es) 2021-12-02
AU2015350148A1 (en) 2017-06-15
EP4039247B1 (en) 2025-11-05
KR102811263B1 (ko) 2025-05-23
CN107249567A (zh) 2017-10-13
AU2021201034A1 (en) 2021-03-11
IL278188A (en) 2020-11-30
IL252285A0 (en) 2017-07-31
PL3220891T3 (pl) 2020-08-24
JP6753860B2 (ja) 2020-09-09
US20210038499A1 (en) 2021-02-11
ES2751300T3 (es) 2020-03-31
JP2017535613A (ja) 2017-11-30
MX368838B (es) 2019-10-18
PT3220891T (pt) 2019-10-31
IL252285B (en) 2020-10-29
EP4039247A3 (en) 2022-11-16
CY1122469T1 (el) 2021-01-27
BR112017010423B1 (pt) 2023-09-26
DK3220891T3 (da) 2019-11-04
EP3220891A1 (en) 2017-09-27
HRP20191892T8 (hr) 2020-09-18
KR102580378B1 (ko) 2023-09-19
EA038518B1 (ru) 2021-09-09
WO2016081472A1 (en) 2016-05-26
EP3616686B1 (en) 2021-05-19
KR20170137032A (ko) 2017-12-12
IL278188B1 (en) 2024-11-01
JP2023065398A (ja) 2023-05-12
KR20230135183A (ko) 2023-09-22
CA2967662A1 (en) 2016-05-26
EP3220891B1 (en) 2019-07-24
SI3220891T1 (sl) 2020-02-28
PH12017500934B1 (en) 2024-06-28

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