AU2016343851B2 - Eflornithine and sulindac, fixed dose combination formulation - Google Patents

Eflornithine and sulindac, fixed dose combination formulation Download PDF

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Publication number
AU2016343851B2
AU2016343851B2 AU2016343851A AU2016343851A AU2016343851B2 AU 2016343851 B2 AU2016343851 B2 AU 2016343851B2 AU 2016343851 A AU2016343851 A AU 2016343851A AU 2016343851 A AU2016343851 A AU 2016343851A AU 2016343851 B2 AU2016343851 B2 AU 2016343851B2
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Australia
Prior art keywords
composition
tablet
sulindac
eflomithine
patient
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AU2016343851A
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AU2016343851A1 (en
Inventor
Roberto Carlos Bravo Gonzalez
Jean Ducassou
Patrick Shannon
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Uswm LLC
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Uswm LLC
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Priority claimed from PCT/US2016/059689 external-priority patent/WO2017075576A1/en
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Assigned to USMW, LLC reassignment USMW, LLC Request for Assignment Assignors: CANCER PREVENTION PHARMACEUTICALS, INC.
Assigned to USWM, LLC reassignment USWM, LLC Request to Amend Deed and Register Assignors: USMW, LLC
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    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • 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
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
AU2016343851A 2015-10-30 2016-10-31 Eflornithine and sulindac, fixed dose combination formulation Active AU2016343851B2 (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201562248810P 2015-10-30 2015-10-30
US62/248,810 2015-10-30
US201662358698P 2016-07-06 2016-07-06
US62/358,698 2016-07-06
EP16306430 2016-10-28
EP16306429 2016-10-28
EP16306429.8 2016-10-28
EP16306430.6 2016-10-28
PCT/US2016/059689 WO2017075576A1 (en) 2015-10-30 2016-10-31 Eflornithine and sulindac, fixed dose combination formulation

Publications (2)

Publication Number Publication Date
AU2016343851A1 AU2016343851A1 (en) 2018-05-10
AU2016343851B2 true AU2016343851B2 (en) 2022-04-07

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AU2016343851A Active AU2016343851B2 (en) 2015-10-30 2016-10-31 Eflornithine and sulindac, fixed dose combination formulation

Country Status (14)

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US (4) US10973790B2 (enExample)
EP (1) EP3368029B1 (enExample)
JP (3) JP2018536707A (enExample)
KR (3) KR20180069068A (enExample)
CN (1) CN108366982A (enExample)
AU (1) AU2016343851B2 (enExample)
BR (1) BR112018008651A2 (enExample)
CA (1) CA3003149C (enExample)
CL (1) CL2018001157A1 (enExample)
CO (1) CO2018005491A2 (enExample)
HK (1) HK1258284A1 (enExample)
IL (1) IL259009A (enExample)
MA (1) MA43114A (enExample)
MX (1) MX390899B (enExample)

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JP2018536707A (ja) 2015-10-30 2018-12-13 キャンサー プリベンション ファーマシューティカルズ，インコーポレイテッド エフロルニチンとスリンダクの固定用量複合製剤
NZ792518A (en) 2016-10-06 2023-04-28 Orbus Therapeutics Inc Formulations for administration of eflornithine
TWI917322B (zh) 2019-05-17 2026-03-11 美商癌症預防製藥股份有限公司 治療家族性腺瘤性瘜肉症之方法
US12605349B2 (en) 2024-09-05 2026-04-21 Orbus Therapeutics, Inc. Methods of treating grade 3 astrocytoma
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EP3368029C0 (en) 2026-05-27
EP3368029A1 (en) 2018-09-05
MA43114A (fr) 2018-09-05
US20230172887A1 (en) 2023-06-08
MX390899B (es) 2025-03-21
MX2018005350A (es) 2018-08-14
CA3003149A1 (en) 2017-05-04
US20240173284A1 (en) 2024-05-30
JP7592001B2 (ja) 2024-11-29
IL259009A (en) 2018-07-31
US11925613B2 (en) 2024-03-12
EP3368029B1 (en) 2026-05-27
KR20180069068A (ko) 2018-06-22
CN108366982A (zh) 2018-08-03
CL2018001157A1 (es) 2018-09-07
US20200009098A1 (en) 2020-01-09
CO2018005491A2 (es) 2018-06-12
US10973790B2 (en) 2021-04-13
BR112018008651A2 (en) 2018-10-30
KR20260033630A (ko) 2026-03-10
JP2024102339A (ja) 2024-07-30
KR20240162560A (ko) 2024-11-15
HK1258284A1 (zh) 2019-11-08
JP2018536707A (ja) 2018-12-13
US12350246B2 (en) 2025-07-08
JP2022028814A (ja) 2022-02-16
CA3003149C (en) 2023-10-31
AU2016343851A1 (en) 2018-05-10
US11529326B2 (en) 2022-12-20
US20210267926A1 (en) 2021-09-02

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