DK1931689T3 - Ferricitrat af farmaceutisk kvalitet til medicinsk anvendelse - Google Patents

Ferricitrat af farmaceutisk kvalitet til medicinsk anvendelse Download PDF

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Publication number
DK1931689T3
DK1931689T3 DK06813544.1T DK06813544T DK1931689T3 DK 1931689 T3 DK1931689 T3 DK 1931689T3 DK 06813544 T DK06813544 T DK 06813544T DK 1931689 T3 DK1931689 T3 DK 1931689T3
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DK
Denmark
Prior art keywords
ferric
ferric citrate
citrate
precipitate
composition
Prior art date
Application number
DK06813544.1T
Other languages
English (en)
Inventor
Keith Chan
Winston Town
Original Assignee
Panion & Bf Biotech Inc
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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48087784&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1931689(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US11/206,981 external-priority patent/US7767851B2/en
Application filed by Panion & Bf Biotech Inc filed Critical Panion & Bf Biotech Inc
Application granted granted Critical
Publication of DK1931689T3 publication Critical patent/DK1931689T3/da

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F15/00—Compounds containing elements of Groups 8, 9, 10 or 18 of the Periodic Table
    • C07F15/02—Iron compounds
    • 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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/295—Iron group metal compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • 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
    • 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
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/41—Preparation of salts of carboxylic acids
    • C07C51/412—Preparation of salts of carboxylic acids by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/42—Separation; Purification; Stabilisation; Use of additives

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (11)

  1. Ferricitrat af farmaceutisk kvalitet til medicinsk anvendelse
    1. Præparat til anvendelse ved behandling af en lidelse, hvilket præparat er kendetegnet ved et højt serumphosphatniveau, idet præparatet omfatter en mængde ferricitrat af farmaceutisk kvalitet, som er effektiv til at reducere serumphosphatniveauer, hvor mængden af administreret ferricitrat af farmaceutisk kvalitet er fra 2 gram i døgnet til 30 gram i døgnet, og hvor ferricitratet fremstilles ved en fremgangsmåde, som omfatter følgende trin: (a) opløsning af en passende mængde ferrichloridhexahydrat i vand til dannelse af en ferrichloridhexahydratopløsning; (b) opløsning af en passende mængde NaOH i vand til dannelse af en NaOH-opløsning; (c) blanding af ferrichloridhexahydratopløsningen og NaOH-opløsningen til dannelse af en opløsning med Fe(OH)3-præcipitat; (d) opretholdelse af pH-værdien for opløsningen med Fe(OH)3-præcipitat på over 7,0; (e) isolering af Fe(OH)3-præcipitatet; (f) vaskning af Fe(OH)3-præcipitatet tre gange med vand; (g) suspendering af Fe(OH)3-præcipitatet i vand; (h) tilsætning af citronsyre til Fe(OH)3-præcipitatet til dannelse af en ferri-organisk syreopløsning; (i) omrøring og opvarmning af den ferri-organiske syreopløsning ved 90-100°C i 30 til 120 minutter; (j) fjernelse af de faste stoffer i den ferri-organiske syreopløsning ved tilsætning af citronsyre; (k) den ferri-organiske syreopløsning lades afkøle til under 30°C; (l) opretholdelse af den ferri-organiske syreopløsnings pH-værdi på mellem 0,8 og 1,5; (m) filtrering af den ferri-organiske syreopløsning for at opnå et flydende filtrat; (n) blanding af acetone og flydende filtrat til dannelse af ferricitrat; (0) isolering af ferricitrat; (p) vaskning af ferricitrat med acetone tre gange; (q) tørring af ferricitratet.
  2. 2. Præparat til anvendelse ifølge krav 1, hvor ferricitratet er i en oralt administrerbar form.
  3. 3. Præparat til anvendelse ifølge krav 1 eller 2, hvor den administrerede mængde er fra 4 gram i døgnet til 15 gram i døgnet.
  4. 4. Præparat til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor den administrerede mængde er fra 4 gram i døgnet til 8 gram i døgnet.
  5. 5. Præparat til anvendelse ifølge krav 1, hvor den administrerede mængde er valgt blandt 2, 4 og 6 gram i døgnet.
  6. 6. Præparat til anvendelse ifølge et hvilket som helst af kravene 1 til 5, hvor ferricitratet tilvejebringer en mere ønskværdig profil vedrørende ugunstige bivirkninger.
  7. 7. Præparat til anvendelse ifølge et hvilket som helst af kravene 1 til 6, hvor den effektive mængde er egnet til oral langtidsadministration.
  8. 8. Præparat til anvendelse ifølge et hvilket som helst af kravene 1 til 7, hvor ferri-ioner frigives i mave-tarm-kanalen og bringes i kontakt med phosphatholdige forbindelser i mave-tarm-kanalen.
  9. 9. Præparat til anvendelse ifølge krav 8, hvor ferri-ioner og de i kontakt bragte phosphatholdige forbindelser kombineres i en uopløselig form.
  10. 10. Præparat til anvendelse ifølge et hvilket som helst af kravene 1 til 9, hvor citratet frigives og kan absorberes i mave-tarm-kanalen.
  11. 11. Præparat til anvendelse ifølge krav 1, hvor den mængde ferricitrat af farmaceutisk kvalitet, der administreres i døgnet, er ca. 30 gram - eller mindre, når ferricitratet af farmaceutisk kvalitet administreres i tabletform.
DK06813544.1T 2005-08-18 2006-08-18 Ferricitrat af farmaceutisk kvalitet til medicinsk anvendelse DK1931689T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/206,981 US7767851B2 (en) 2003-02-19 2005-08-18 Ferric organic compounds, uses thereof and methods of making same
US70951105P 2005-08-19 2005-08-19
PCT/US2006/032385 WO2007022435A2 (en) 2005-08-18 2006-08-18 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same

Publications (1)

Publication Number Publication Date
DK1931689T3 true DK1931689T3 (da) 2015-06-01

Family

ID=48087784

Family Applications (1)

Application Number Title Priority Date Filing Date
DK06813544.1T DK1931689T3 (da) 2005-08-18 2006-08-18 Ferricitrat af farmaceutisk kvalitet til medicinsk anvendelse

Country Status (16)

Country Link
EP (2) EP2594551B1 (da)
JP (2) JP5667343B2 (da)
KR (1) KR20080037083A (da)
CN (1) CN101253186A (da)
AU (1) AU2006279333C1 (da)
CA (2) CA2619591C (da)
DK (1) DK1931689T3 (da)
EA (1) EA018245B1 (da)
ES (1) ES2539635T3 (da)
HU (1) HUE025264T2 (da)
IL (2) IL189583A (da)
MX (2) MX354649B (da)
MY (1) MY162727A (da)
NZ (1) NZ566743A (da)
TW (1) TWI375555B (da)
WO (1) WO2007022435A2 (da)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
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US8093423B2 (en) 2003-02-19 2012-01-10 Globoasia, Llc Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same
TWI335218B (en) 2003-02-19 2011-01-01 Panion & Bf Biotech Inc Ferric organic compounds, uses thereof and methods of making same
JP2009525277A (ja) * 2006-01-30 2009-07-09 グロボアジア エルエルシー 軟組織石灰化の回復、予防、遅延または安定化方法
US7985429B2 (en) 2006-03-03 2011-07-26 C. B. Fleet Company, Inc. Flavored colonic cleansing system
US7998510B2 (en) 2006-08-17 2011-08-16 C. B. Fleet Company, Inc. Low dose colonic cleansing system
WO2008058438A1 (fr) * 2006-11-17 2008-05-22 Jung-Ren Su Utilisation de citrate ferrique dans la préparation de médicaments servant à traiter la calcification des vaisseaux sanguins
EP2194977A1 (en) * 2007-08-31 2010-06-16 C.B. Fleet Company Incorporated Method of preventing nephrocalcinosis
WO2011011541A1 (en) * 2009-07-21 2011-01-27 Henry Trong Le Ferric citrate dosage forms
JP5167389B2 (ja) * 2010-07-07 2013-03-21 日本たばこ産業株式会社 クエン酸第二鉄を含む錠剤
JP2012162522A (ja) * 2011-01-18 2012-08-30 Japan Tobacco Inc β酸化水酸化鉄を実質的に含まないクエン酸第二鉄
KR101455921B1 (ko) * 2012-01-30 2014-11-12 성균관대학교산학협력단 수난용성 약물을 내부에 포함하는 알부민 나노입자 제조방법
US20130345303A1 (en) 2012-06-21 2013-12-26 Keryx Biopharmaceuticals, Inc. Use of ferric citrate in the treatment of chronic kidney disease patients
US9539283B2 (en) * 2012-09-04 2017-01-10 The Board Of Regents Of The University Of Texas System Citrate-rich calcium-magnesium supplement and uses thereof
EP3003327B1 (en) 2013-06-05 2017-08-09 Tricida Inc. Proton-binding polymers for oral administration
EP3747432A1 (en) * 2013-11-04 2020-12-09 Keryx Biopharmaceuticals, Inc. Ferric citrate for reducing cardiac failure in chronic kidney disease patients
RS61409B1 (sr) 2014-12-10 2021-03-31 Tricida Inc Polimeri koji vezuju protone za oralnu primenu opis
EP3233783A4 (en) * 2014-12-17 2018-06-27 Biophore India Pharmaceuticals Pvt. Ltd. Improved method for the synthesis of ferric oraganic compounds
JP6206420B2 (ja) * 2015-01-13 2017-10-04 テクノサイエンス株式会社 クエン酸第二鉄を高濃度で含有するゲル状組成物の製造方法
TW202302083A (zh) * 2015-03-04 2023-01-16 美商凱克斯生物製藥公司 檸檬酸鐵用於治療缺鐵性貧血之用途
WO2016162888A1 (en) * 2015-04-09 2016-10-13 Actavis Group Ptc Ehf. Process for preparing pharmaceutical grade ferric citrate
CN109414453B (zh) 2016-05-06 2023-02-17 特里赛达公司 用于治疗酸碱失衡的组合物
US10934380B1 (en) 2017-09-25 2021-03-02 Tricida, Inc. Crosslinked poly(allylamine) polymer pharmaceutical compositions
CA3080651A1 (en) 2017-11-03 2019-05-09 Tricida, Inc. Compositions for and method of treating acid-base disorders
CN108863771A (zh) * 2018-05-24 2018-11-23 国药集团化学试剂有限公司 一种柠檬酸铁结晶的制备方法
JP7175235B2 (ja) * 2019-04-19 2022-11-18 株式会社トクヤマ クエン酸第二鉄水和物の製造方法
CN110105194A (zh) * 2019-05-10 2019-08-09 上海万巷制药有限公司 一种药用级柠檬酸铁的制备方法
EP4347022A1 (en) 2021-05-27 2024-04-10 Keryx Biopharmaceuticals, Inc. Pediatric formulations of ferric citrate
WO2026017897A1 (en) 2024-07-18 2026-01-22 Malian Biologicals Gmbh Iron supplementation in affective disorders and/or post-traumatic stress disorder (ptsd) and/or serotonin-dependent diseases

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US5753706A (en) * 1996-12-16 1998-05-19 Hsu; Chen Hsing Methods for treating renal failure
CN1315174A (zh) 2000-03-31 2001-10-03 苏荣仁 治疗肾衰的药物组合物
TWI335218B (en) * 2003-02-19 2011-01-01 Panion & Bf Biotech Inc Ferric organic compounds, uses thereof and methods of making same
US6903235B2 (en) * 2003-10-08 2005-06-07 Panion & Bf Biotech Inc. Pharmaceutical-grade ferric citrate

Also Published As

Publication number Publication date
AU2006279333C1 (en) 2012-12-13
EP2594551B1 (en) 2025-02-19
MX2008002360A (es) 2008-04-29
NZ566743A (en) 2010-07-30
CA2619591A1 (en) 2007-02-22
CA3050453A1 (en) 2007-02-22
EP1931689B1 (en) 2015-02-25
EP1931689A4 (en) 2011-02-09
WO2007022435A2 (en) 2007-02-22
TW200740431A (en) 2007-11-01
MX354649B (es) 2018-03-14
EA018245B1 (ru) 2013-06-28
EP2594551A1 (en) 2013-05-22
AU2006279333B2 (en) 2012-07-26
JP2009504777A (ja) 2009-02-05
IL189583A0 (en) 2008-08-07
JP5667343B2 (ja) 2015-02-12
IL228952B (en) 2018-06-28
IL189583A (en) 2013-10-31
ES2539635T3 (es) 2015-07-02
EA200800593A1 (ru) 2008-10-30
IL228952A0 (en) 2013-12-31
TWI375555B (en) 2012-11-01
JP2013177416A (ja) 2013-09-09
WO2007022435A3 (en) 2007-05-10
HUE025264T2 (en) 2016-02-29
CN101253186A (zh) 2008-08-27
EP1931689A2 (en) 2008-06-18
CA3050453C (en) 2021-07-27
MY162727A (en) 2017-07-14
CA2619591C (en) 2020-03-24
KR20080037083A (ko) 2008-04-29
AU2006279333A1 (en) 2007-02-22

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