AU2019395288B2 - Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds - Google Patents

Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds Download PDF

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Publication number
AU2019395288B2
AU2019395288B2 AU2019395288A AU2019395288A AU2019395288B2 AU 2019395288 B2 AU2019395288 B2 AU 2019395288B2 AU 2019395288 A AU2019395288 A AU 2019395288A AU 2019395288 A AU2019395288 A AU 2019395288A AU 2019395288 B2 AU2019395288 B2 AU 2019395288B2
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AU
Australia
Prior art keywords
perampanel
group
pharmaceutical formulation
hydrate
cyclodextrin
Prior art date
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Active
Application number
AU2019395288A
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English (en)
Other versions
AU2019395288A1 (en
Inventor
Ganesh S. P. Bommareddy
Geoffrey S. Hird
Anjali Joshi
James Mcshane
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.)
Eisai R&D Management Co Ltd
Original Assignee
Eisai R&D Management 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.)
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Publication date
Application filed by Eisai R&D Management Co Ltd filed Critical Eisai R&D Management Co Ltd
Publication of AU2019395288A1 publication Critical patent/AU2019395288A1/en
Application granted granted Critical
Publication of AU2019395288B2 publication Critical patent/AU2019395288B2/en
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Classifications

    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61K9/19Particulate 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
    • 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
    • A61P25/28Drugs 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2019395288A 2018-12-14 2019-12-16 Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds Active AU2019395288B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862779620P 2018-12-14 2018-12-14
US62/779,620 2018-12-14
PCT/US2019/066622 WO2020124090A1 (en) 2018-12-14 2019-12-16 Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds

Publications (2)

Publication Number Publication Date
AU2019395288A1 AU2019395288A1 (en) 2021-09-23
AU2019395288B2 true AU2019395288B2 (en) 2025-04-03

Family

ID=69174604

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019395288A Active AU2019395288B2 (en) 2018-12-14 2019-12-16 Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds

Country Status (11)

Country Link
US (1) US12303499B2 (https=)
EP (1) EP3893844A1 (https=)
JP (1) JP7177937B2 (https=)
KR (1) KR102912861B1 (https=)
CN (1) CN113226286B (https=)
AU (1) AU2019395288B2 (https=)
BR (1) BR112021010953A2 (https=)
CA (1) CA3122705A1 (https=)
MA (1) MA54460A (https=)
MX (1) MX2021006317A (https=)
WO (1) WO2020124090A1 (https=)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104706604A (zh) * 2013-12-12 2015-06-17 北京星昊医药股份有限公司 一种吡仑帕奈冻干口崩片及其制备方法
WO2018169798A1 (en) * 2017-03-11 2018-09-20 The Regents Of The University Of California Mitigation of cns disorders by combination therapy using neurosteroids, and ampa blockers

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US5356902A (en) 1992-11-06 1994-10-18 Eli Lilly And Company Decahydroisoquinoline compounds as excitatory amino acid receptor antagonists
IL109397A0 (en) 1993-04-28 1994-07-31 Schering Ag Quinoxalinedione derivatives, processes for the preparation thereof and pharmaceutical compositions containing the same
HU219777B (hu) 1993-07-02 2001-07-30 Gyógyszerkutató Intézet Kft. Optikailag aktív 1-(4-nitro-fenil)-4-metil-7,8-metiléndioxi-3,4-dihidro-5H-2,3-benzodiazepin és eljárás előállítására
DK0784054T3 (da) 1994-09-27 2002-03-25 Yamanouchi Pharma Co Ltd 1,2,3,4-tetrahydroquinoxalinderivater og deres anvendelse som glutamatreceptorantagonister
US5935551A (en) 1995-11-15 1999-08-10 California Institute Of Technology Synthesis of zeolites by hydrothermal reaction of zeolite P1
DE19604920A1 (de) 1996-02-01 1997-08-07 Schering Ag Neue 2,3-Benzodiazepinderivate, deren Herstellung und Verwendung als Arzneimittel
US5891871A (en) 1996-03-21 1999-04-06 Cocensys, Inc. Substituted 2,3-benzodiazepin-4-ones and the use thereof
HU9600871D0 (en) 1996-04-04 1996-05-28 Gyogyszerkutato Intezet New 2,3-benzodiazepine derivatives
CN1103772C (zh) 1996-05-15 2003-03-26 辉瑞大药厂 新的2,3-二取代-4(3h)-喹唑啉酮类化合物
DE19643037A1 (de) 1996-10-18 1998-04-23 Boehringer Ingelheim Kg Neue Oxadiazole, Verfahren zu ihrer Herstellung sowie deren Verwendung als Arzneimittel
SK113299A3 (en) 1997-02-28 2001-05-10 Pfizer Prod Inc Atropisomers of 3-aryl-4(3h)-quinazolinones and their use as ampa-receptor antagonists
GB9711753D0 (en) 1997-06-06 1997-08-06 Merck Sharp & Dohme Therapeutic agents
WO2000001376A2 (en) 1998-07-02 2000-01-13 Eisai Co., Ltd Pharmaceutical compositions and their uses for treatment of demyelinating disorders
DE19835918A1 (de) 1998-08-07 2000-02-10 Dresden Arzneimittel Neue antikonvulsiv wirkende 4-Amino-1-aryl-pyridin-2-one und Verfahren zu deren Herstellung
ES2320973T3 (es) 2000-06-12 2009-06-01 EISAI R&D MANAGEMENT CO., LTD. Compuestos de 1,2-dihidropiridina, procedimiento para su preparacion y uso de los mismos.
GB0129260D0 (en) 2001-12-06 2002-01-23 Eisai London Res Lab Ltd Pharmaceutical compositions and their uses
MY148809A (en) 2004-07-06 2013-05-31 Eisai R&D Man Co Ltd Crystals of 1,2-dihydropyridine compound and their production process
US7803818B2 (en) 2005-12-21 2010-09-28 Eisai R&D Management Co., Ltd. Amorphous form of 1,2-dihydropyridine compound
WO2008111590A2 (en) 2007-03-05 2008-09-18 Eisai R & D Management Co., Ltd. Ampa and nmda receptor antagonists for neurodegenerative diseases
JP2015227288A (ja) * 2012-08-31 2015-12-17 エーザイ・アール・アンド・ディー・マネジメント株式会社 けいれん重積発作の治療用医薬組成物
CN104644592A (zh) * 2013-11-25 2015-05-27 天津市汉康医药生物技术有限公司 一种吡仑帕奈药物组合物及其制备方法
CA2973140C (en) * 2015-02-06 2025-09-16 Marinus Pharmaceuticals, Inc. Intravenous Ganaxolone Formulations and Their Use in the Treatment of Status Epilepticus and Other Epileptic Disorders
CN106389367B (zh) 2016-11-16 2020-12-18 杭州朱养心药业有限公司 吡仑帕奈包衣片剂药物组合物

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104706604A (zh) * 2013-12-12 2015-06-17 北京星昊医药股份有限公司 一种吡仑帕奈冻干口崩片及其制备方法
WO2018169798A1 (en) * 2017-03-11 2018-09-20 The Regents Of The University Of California Mitigation of cns disorders by combination therapy using neurosteroids, and ampa blockers

Also Published As

Publication number Publication date
AU2019395288A1 (en) 2021-09-23
CN113226286B (zh) 2024-08-20
WO2020124090A1 (en) 2020-06-18
US20220023275A1 (en) 2022-01-27
MA54460A (fr) 2021-10-20
US12303499B2 (en) 2025-05-20
KR20210107644A (ko) 2021-09-01
KR102912861B1 (ko) 2026-01-15
JP7177937B2 (ja) 2022-11-24
MX2021006317A (es) 2021-08-11
EP3893844A1 (en) 2021-10-20
JP2022510947A (ja) 2022-01-28
CN113226286A (zh) 2021-08-06
BR112021010953A2 (pt) 2021-08-24
CA3122705A1 (en) 2020-06-18

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Free format text: THE TIME IN WHICH TO ENTER THE NATIONAL PHASE HAS BEEN EXTENDED TO 14 SEP 2021

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