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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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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (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 (cg-RX-API-DMAC7.html)
EP (1) EP3344235A1 (cg-RX-API-DMAC7.html)
JP (1) JP7055738B2 (cg-RX-API-DMAC7.html)
KR (1) KR20180050346A (cg-RX-API-DMAC7.html)
CN (1) CN108601738A (cg-RX-API-DMAC7.html)
AU (1) AU2016315877B2 (cg-RX-API-DMAC7.html)
BR (1) BR112018004244A2 (cg-RX-API-DMAC7.html)
CA (1) CA2997328A1 (cg-RX-API-DMAC7.html)
CL (1) CL2018000566A1 (cg-RX-API-DMAC7.html)
CO (1) CO2018002421A2 (cg-RX-API-DMAC7.html)
EA (1) EA201890642A1 (cg-RX-API-DMAC7.html)
IL (1) IL257796B (cg-RX-API-DMAC7.html)
MX (1) MX2018002633A (cg-RX-API-DMAC7.html)
PE (1) PE20181162A1 (cg-RX-API-DMAC7.html)
PH (1) PH12018500463A1 (cg-RX-API-DMAC7.html)
SG (1) SG10202107245UA (cg-RX-API-DMAC7.html)
UA (1) UA124923C2 (cg-RX-API-DMAC7.html)
WO (1) WO2017040937A1 (cg-RX-API-DMAC7.html)

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
WO1997014407A1 (en) * 1995-10-17 1997-04-24 Research Triangle Pharmaceuticals 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
CA2344548C (en) * 1998-09-18 2007-03-13 Rockwell Medical Technologies, Inc. Method and apparatus for preparing liquid dialysate
WO2001080828A2 (en) * 2000-04-20 2001-11-01 Rtp Pharma Inc. Improved water-insoluble drug particle process
CA2433169A1 (en) 2000-12-26 2002-07-04 Takeda Chemical Industries, Ltd. Porous substances and methods for producing the same
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
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
EP1743530B1 (en) * 2005-07-15 2011-08-31 Unilever N.V. Iron fortified food product and additive
WO2014121155A1 (en) 2013-02-01 2014-08-07 Charak Llc Methods of treating iron deficiency with soluble ferric pyrophosphate

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

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MK4 Application lapsed section 142(2)(d) - no continuation fee paid for the application