AU2015214502B2 - Tablet formulation for CGRP-active compounds - Google Patents

Tablet formulation for CGRP-active compounds Download PDF

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Publication number
AU2015214502B2
AU2015214502B2 AU2015214502A AU2015214502A AU2015214502B2 AU 2015214502 B2 AU2015214502 B2 AU 2015214502B2 AU 2015214502 A AU2015214502 A AU 2015214502A AU 2015214502 A AU2015214502 A AU 2015214502A AU 2015214502 B2 AU2015214502 B2 AU 2015214502B2
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AU
Australia
Prior art keywords
tablet
compound
formula
extrudate
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.)
Active, expires
Application number
AU2015214502A
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English (en)
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AU2015214502A1 (en
Inventor
Leonardo Resende ALLAIN
Chad D. Brown
W. Mark Eickhoff
Francis J. Flanagan Jr.
Craig B. Ikeda
Mary Ann Johnson
Lisa LUPTON
Melanie MAROTA
Rebecca NOFSINGER
Paresh B. Patel
Hanmi XI
Wei Xu
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Merck Sharp and Dohme LLC
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Merck Sharp and Dohme LLC
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Application filed by Merck Sharp and Dohme LLC filed Critical Merck Sharp and Dohme LLC
Publication of AU2015214502A1 publication Critical patent/AU2015214502A1/en
Application granted granted Critical
Publication of AU2015214502B2 publication Critical patent/AU2015214502B2/en
Priority to AU2019226239A priority Critical patent/AU2019226239B2/en
Priority to AU2021245229A priority patent/AU2021245229A1/en
Assigned to MERCK SHARP & DOHME LLC reassignment MERCK SHARP & DOHME LLC Request to Amend Deed and Register Assignors: MERCK SHARP & DOHME CORP.
Priority to AU2023258317A priority patent/AU2023258317A1/en
Priority to AU2025220825A priority patent/AU2025220825A1/en
Active legal-status Critical Current
Adjusted expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/4353Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Cephalosporin Compounds (AREA)
AU2015214502A 2014-02-05 2015-01-30 Tablet formulation for CGRP-active compounds Active 2038-12-12 AU2015214502B2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2019226239A AU2019226239B2 (en) 2014-02-05 2019-09-06 Tablet formulation for CGRP-active compounds
AU2021245229A AU2021245229A1 (en) 2014-02-05 2021-10-08 Tablet formulation for CGRP-active compounds
AU2023258317A AU2023258317A1 (en) 2014-02-05 2023-10-30 Tablet formulation for CGRP-active compounds
AU2025220825A AU2025220825A1 (en) 2014-02-05 2025-08-22 Tablet formulation for CGRP-active compounds

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461936019P 2014-02-05 2014-02-05
US61/936,019 2014-02-05
US201462087366P 2014-12-04 2014-12-04
US62/087,366 2014-12-04
PCT/US2015/013672 WO2015119848A1 (en) 2014-02-05 2015-01-30 Tablet formulation for cgrp-active compounds

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2019226239A Division AU2019226239B2 (en) 2014-02-05 2019-09-06 Tablet formulation for CGRP-active compounds

Publications (2)

Publication Number Publication Date
AU2015214502A1 AU2015214502A1 (en) 2016-07-21
AU2015214502B2 true AU2015214502B2 (en) 2019-06-06

Family

ID=53778348

Family Applications (5)

Application Number Title Priority Date Filing Date
AU2015214502A Active 2038-12-12 AU2015214502B2 (en) 2014-02-05 2015-01-30 Tablet formulation for CGRP-active compounds
AU2019226239A Active AU2019226239B2 (en) 2014-02-05 2019-09-06 Tablet formulation for CGRP-active compounds
AU2021245229A Abandoned AU2021245229A1 (en) 2014-02-05 2021-10-08 Tablet formulation for CGRP-active compounds
AU2023258317A Abandoned AU2023258317A1 (en) 2014-02-05 2023-10-30 Tablet formulation for CGRP-active compounds
AU2025220825A Pending AU2025220825A1 (en) 2014-02-05 2025-08-22 Tablet formulation for CGRP-active compounds

Family Applications After (4)

Application Number Title Priority Date Filing Date
AU2019226239A Active AU2019226239B2 (en) 2014-02-05 2019-09-06 Tablet formulation for CGRP-active compounds
AU2021245229A Abandoned AU2021245229A1 (en) 2014-02-05 2021-10-08 Tablet formulation for CGRP-active compounds
AU2023258317A Abandoned AU2023258317A1 (en) 2014-02-05 2023-10-30 Tablet formulation for CGRP-active compounds
AU2025220825A Pending AU2025220825A1 (en) 2014-02-05 2025-08-22 Tablet formulation for CGRP-active compounds

Country Status (13)

Country Link
US (4) US10117836B2 (enExample)
EP (1) EP3102564A4 (enExample)
JP (2) JP6491669B2 (enExample)
KR (3) KR102448369B1 (enExample)
CN (2) CN112022818A (enExample)
AU (5) AU2015214502B2 (enExample)
CA (1) CA2937315A1 (enExample)
HK (1) HK1232218A1 (enExample)
IL (1) IL246828B (enExample)
MX (2) MX383378B (enExample)
RU (2) RU2019123406A (enExample)
SA (1) SA516371613B1 (enExample)
WO (1) WO2015119848A1 (enExample)

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US12168004B2 (en) 2014-02-05 2024-12-17 Merck Sharp & Dohme Llc Treatment of migraine
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US11717515B2 (en) 2020-12-22 2023-08-08 Allergan Pharmaceuticals International Limited Treatment of migraine
CN105126111A (zh) * 2015-09-30 2015-12-09 清华大学 提高索拉非尼生物利用度的制剂
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US12383545B1 (en) 2018-06-08 2025-08-12 Allergan Pharmaceuticals International Limited Treatment of migraine
RU2755571C1 (ru) * 2020-06-09 2021-09-17 Сергей Геннадьевич Каплунов Способ изготовления гравюры на металле
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CN116456981A (zh) * 2020-11-19 2023-07-18 辉瑞爱尔兰制药公司 用于改善的grp抑制剂递送的组合物
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TW202241447A (zh) * 2021-02-02 2022-11-01 瑞士商愛杜西亞製藥有限公司 (4-甲基-2-[1,2,3]三唑-2-基-苯基)-[(r)-3-(3-[1,2,3]三唑-2-基-苄基)-嗎啉-4-基]-甲酮之結晶形式
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