CA2914049C - Pharmaceutical formulations of a hif hydroxylase inhibitor - Google Patents

Pharmaceutical formulations of a hif hydroxylase inhibitor Download PDF

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Publication number
CA2914049C
CA2914049C CA2914049A CA2914049A CA2914049C CA 2914049 C CA2914049 C CA 2914049C CA 2914049 A CA2914049 A CA 2914049A CA 2914049 A CA2914049 A CA 2914049A CA 2914049 C CA2914049 C CA 2914049C
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CA
Canada
Prior art keywords
red
iron oxide
capsule
titanium dioxide
tablet
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
CA2914049A
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English (en)
French (fr)
Other versions
CA2914049A1 (en
Inventor
David CONCA
Lee Allen Flippin
Scott David Leigh
Claudia WITSCHI
Lee Robert Wright
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.)
Fibrogen Inc
Original Assignee
Fibrogen Inc
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Publication date
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Application filed by Fibrogen Inc filed Critical Fibrogen Inc
Publication of CA2914049A1 publication Critical patent/CA2914049A1/en
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Classifications

    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • 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
    • 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
    • A61K47/02—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
    • A61K9/2009—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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—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
    • A61K9/20—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
    • A61K9/28—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
    • A61K9/282—Organic compounds, e.g. 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4883—Capsule finishing, e.g. dyeing, aromatising, polishing
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2914049A 2013-06-06 2014-06-05 Pharmaceutical formulations of a hif hydroxylase inhibitor Active CA2914049C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361831909P 2013-06-06 2013-06-06
US61/831,909 2013-06-06
PCT/US2014/041021 WO2014197660A1 (en) 2013-06-06 2014-06-05 Pharmaceutical formulations of a hif hydroxylase inhibitor

Publications (2)

Publication Number Publication Date
CA2914049A1 CA2914049A1 (en) 2014-12-11
CA2914049C true CA2914049C (en) 2021-10-12

Family

ID=51063834

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2914049A Active CA2914049C (en) 2013-06-06 2014-06-05 Pharmaceutical formulations of a hif hydroxylase inhibitor

Country Status (24)

Country Link
US (3) US20160120859A1 (enExample)
EP (2) EP3003284B1 (enExample)
JP (4) JP6604941B2 (enExample)
KR (3) KR102291860B1 (enExample)
CN (5) CN105377242A (enExample)
AU (1) AU2014274890B2 (enExample)
CA (1) CA2914049C (enExample)
CY (1) CY1122951T1 (enExample)
DK (1) DK3003284T3 (enExample)
ES (1) ES2786924T3 (enExample)
HR (1) HRP20200615T1 (enExample)
HU (1) HUE049623T2 (enExample)
IL (3) IL296484B2 (enExample)
LT (1) LT3003284T (enExample)
ME (1) ME03777B (enExample)
MX (3) MX2015016536A (enExample)
PL (1) PL3003284T3 (enExample)
PT (1) PT3003284T (enExample)
RS (1) RS60464B1 (enExample)
SG (1) SG11201509764RA (enExample)
SI (1) SI3003284T1 (enExample)
SM (1) SMT202000190T1 (enExample)
WO (1) WO2014197660A1 (enExample)
ZA (1) ZA201508712B (enExample)

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CN103145616B (zh) 2003-06-06 2015-09-30 菲布罗根有限公司 含氮杂芳基化合物及其在增加内源性促红细胞生成素中的用途
WO2010056767A1 (en) 2008-11-14 2010-05-20 Fibrogen, Inc. Thiochromene derivatives as hip hydroxylase inhibitors
SG11201500234YA (en) 2012-07-16 2015-02-27 Fibrogen Inc Process for making isoquinoline compounds
US8883823B2 (en) 2012-07-16 2014-11-11 Fibrogen, Inc. Crystalline forms of a prolyl hydroxylase inhibitor
EP3470397B1 (en) 2012-07-16 2021-12-29 Fibrogen, Inc. Crystalline forms of a prolyl hydroxylase inhibitor
IL296484B2 (en) 2013-06-06 2025-03-01 Fibrogen Inc Pharmaceutical formulations of HIF hydroxylase inhibitor
NZ735973A (en) 2015-04-01 2023-06-30 Akebia Therapeutics Inc Compositions and methods for treating anemia
WO2019042485A1 (en) 2017-08-30 2019-03-07 Zentiva, K.S. FORMS IN THE STRONG STATE OF ROXADUSTAT
ES2898878T3 (es) 2017-09-04 2022-03-09 Sandoz Ag Cocristal de un inhibidor de la prolil·hidroxilasa de HIF disponible por vía oral
CN110664814A (zh) * 2019-10-24 2020-01-10 上海长海医院 Fg-4592在制备治疗炎性肠病药物中的用途
CN110934833B (zh) * 2019-12-17 2022-08-19 河北长天药业有限公司 一种复方氨酚那敏颗粒
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WO2025111214A1 (en) 2023-11-22 2025-05-30 Fibrogen, Inc. [(4-hydroxy-1-methyl-7-phenoxyisoquinoline-3- carbonyl)amino]acetic acid (roxadustat) for the treatment of anemia in subjects with myelodysplastic syndrome (mds)
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Publication number Publication date
RU2015151056A3 (enExample) 2018-05-03
RS60464B1 (sr) 2020-07-31
AU2014274890B2 (en) 2019-10-03
LT3003284T (lt) 2020-04-27
IL242759B1 (en) 2023-01-01
IL296484B1 (en) 2024-11-01
CY1122951T1 (el) 2021-10-29
US10765672B2 (en) 2020-09-08
IL242759A (enExample) 2015-12-31
IL242759B2 (en) 2023-05-01
JP2023068197A (ja) 2023-05-16
RU2681304C2 (ru) 2019-03-06
ME03777B (me) 2021-04-20
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