AU2016315877B2 - Solid soluble ferric pyrophosphate formulations, kits, and methods using the same - Google Patents

Solid soluble ferric pyrophosphate formulations, kits, and methods using the same Download PDF

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Publication number
AU2016315877B2
AU2016315877B2 AU2016315877A AU2016315877A AU2016315877B2 AU 2016315877 B2 AU2016315877 B2 AU 2016315877B2 AU 2016315877 A AU2016315877 A AU 2016315877A AU 2016315877 A AU2016315877 A AU 2016315877A AU 2016315877 B2 AU2016315877 B2 AU 2016315877B2
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AU
Australia
Prior art keywords
amount
solid particulate
weight
citrate
sfp
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.)
Expired - Fee Related
Application number
AU2016315877A
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English (en)
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AU2016315877A1 (en
Inventor
Robert CHIOINI
Ajay Gupta
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Rockwell Medical Inc
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Rockwell Medical Inc
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Publication date
Application filed by Rockwell Medical Inc filed Critical Rockwell Medical Inc
Publication of AU2016315877A1 publication Critical patent/AU2016315877A1/en
Application granted granted Critical
Publication of AU2016315877B2 publication Critical patent/AU2016315877B2/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/295—Iron group metal 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A61M1/1666—Apparatus for preparing dialysates by dissolving solids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor
    • 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
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • External Artificial Organs (AREA)
AU2016315877A 2015-09-04 2016-09-02 Solid soluble ferric pyrophosphate formulations, kits, and methods using the same Expired - Fee Related AU2016315877B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562214908P 2015-09-04 2015-09-04
US62/214,908 2015-09-04
PCT/US2016/050120 WO2017040937A1 (en) 2015-09-04 2016-09-02 Solid soluble ferric pyrophosphate formulations, kits, and methods using the same

Publications (2)

Publication Number Publication Date
AU2016315877A1 AU2016315877A1 (en) 2018-04-05
AU2016315877B2 true AU2016315877B2 (en) 2022-05-26

Family

ID=56926337

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016315877A Expired - Fee Related AU2016315877B2 (en) 2015-09-04 2016-09-02 Solid soluble ferric pyrophosphate formulations, kits, and methods using the same

Country Status (18)

Country Link
US (1) US11517555B2 (OSRAM)
EP (1) EP3344235A1 (OSRAM)
JP (1) JP7055738B2 (OSRAM)
KR (1) KR20180050346A (OSRAM)
CN (1) CN108601738A (OSRAM)
AU (1) AU2016315877B2 (OSRAM)
BR (1) BR112018004244A2 (OSRAM)
CA (1) CA2997328A1 (OSRAM)
CL (1) CL2018000566A1 (OSRAM)
CO (1) CO2018002421A2 (OSRAM)
EA (1) EA201890642A1 (OSRAM)
IL (1) IL257796B (OSRAM)
MX (1) MX2018002633A (OSRAM)
PE (1) PE20181162A1 (OSRAM)
PH (1) PH12018500463A1 (OSRAM)
SG (1) SG10202107245UA (OSRAM)
UA (1) UA124923C2 (OSRAM)
WO (1) WO2017040937A1 (OSRAM)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11278651B2 (en) * 2018-10-17 2022-03-22 Gambro Lundia Ab Membrane and device for treating restless leg syndrome
CN110063965A (zh) * 2019-06-04 2019-07-30 吉林省富生医疗器械有限公司 一种血液透析浓缩物
FR3109734B1 (fr) * 2020-05-04 2025-04-11 Univ Claude Bernard Lyon Système de dialyse pour le traitement du sepsis

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090023686A1 (en) * 2007-07-20 2009-01-22 Mccall Jr William S Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
US8178709B2 (en) * 2009-07-21 2012-05-15 Biolink Life Sciences, Inc. Iron preparation suitable for pharmaceutical formulation and process for the preparation thereof
WO2012092305A2 (en) * 2010-12-27 2012-07-05 Incube Labs, Llc Nanonized iron compositions and methods of use thereof

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5177068A (en) * 1984-04-19 1993-01-05 National Research Development Corporation Pharmaceutical compositions
CA2234957C (en) * 1995-10-17 2006-12-19 Inge B. Henriksen Insoluble drug delivery
US6779468B1 (en) 1997-08-07 2004-08-24 Ajay Gupta Method and pharmaceutical composition for iron delivery in hemodialysis and peritoneal dialysis patients
US6689275B1 (en) 1996-12-31 2004-02-10 Ajay Gupta Method and pharmaceutical composition for replacing iron losses in dialysis patients
JP3778240B2 (ja) 1998-06-22 2006-05-24 ライオン株式会社 不快な味がマスキングされた造粒組成物及びその製造方法
WO2000016873A1 (en) 1998-09-18 2000-03-30 Rockwell Medical Technologies, Inc. Method and apparatus for preparing liquid dialysate
JP5102423B2 (ja) * 2000-04-20 2012-12-19 オバン・エナジー・リミテッド 改善された水不溶性薬剤粒子の処理
JP2002302435A (ja) 2000-12-26 2002-10-18 Takeda Chem Ind Ltd 多孔性物質およびその製造法
EP1354581A4 (en) 2000-12-26 2007-07-04 Takeda Pharmaceutical POROUS SUBSTANCE AND METHOD FOR THE PRODUCTION THEREOF
US7754243B2 (en) * 2004-08-03 2010-07-13 Clemson University Research Foundation Aqueous suspension of nanoscale drug particles from supercritical fluid processing
US20060134227A1 (en) * 2004-12-22 2006-06-22 Bortz Jonathan D Compositions including iron
US7857977B2 (en) 2005-07-12 2010-12-28 Rockwell Medical Technologies, Inc. Packaging of ferric pyrophosphate for dialysis
ATE522151T1 (de) * 2005-07-15 2011-09-15 Unilever Nv Eisen verstärktes lebensmittel und zusatzstoff
BR112015018549A8 (pt) 2013-02-01 2018-01-30 Charak Llc métodos de tratamento de deficiência de ferro

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090023686A1 (en) * 2007-07-20 2009-01-22 Mccall Jr William S Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
US8178709B2 (en) * 2009-07-21 2012-05-15 Biolink Life Sciences, Inc. Iron preparation suitable for pharmaceutical formulation and process for the preparation thereof
WO2012092305A2 (en) * 2010-12-27 2012-07-05 Incube Labs, Llc Nanonized iron compositions and methods of use thereof

Also Published As

Publication number Publication date
KR20180050346A (ko) 2018-05-14
US20180243256A1 (en) 2018-08-30
US11517555B2 (en) 2022-12-06
UA124923C2 (uk) 2021-12-15
PE20181162A1 (es) 2018-07-19
BR112018004244A2 (pt) 2018-09-25
CO2018002421A2 (es) 2018-07-19
CL2018000566A1 (es) 2018-08-03
EP3344235A1 (en) 2018-07-11
WO2017040937A1 (en) 2017-03-09
AU2016315877A1 (en) 2018-04-05
SG10202107245UA (en) 2021-08-30
CA2997328A1 (en) 2017-03-09
CN108601738A (zh) 2018-09-28
EA201890642A1 (ru) 2018-10-31
JP7055738B2 (ja) 2022-04-18
PH12018500463A1 (en) 2018-09-17
IL257796A (en) 2018-04-30
IL257796B (en) 2021-09-30
JP2018529674A (ja) 2018-10-11
MX2018002633A (es) 2019-02-07

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