JP7055738B2 - 固体の可溶性ピロリン酸第二鉄製剤、キット、およびそれを使用する方法 - Google Patents

固体の可溶性ピロリン酸第二鉄製剤、キット、およびそれを使用する方法 Download PDF

Info

Publication number
JP7055738B2
JP7055738B2 JP2018511682A JP2018511682A JP7055738B2 JP 7055738 B2 JP7055738 B2 JP 7055738B2 JP 2018511682 A JP2018511682 A JP 2018511682A JP 2018511682 A JP2018511682 A JP 2018511682A JP 7055738 B2 JP7055738 B2 JP 7055738B2
Authority
JP
Japan
Prior art keywords
sfp
dialysate
iron
solid
fine particle
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
JP2018511682A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018529674A (ja
JP2018529674A5 (cg-RX-API-DMAC7.html
Inventor
ロバート チオイニ，
アジャイ グプタ，
Original Assignee
ロックウェル メディカル，インコーポレイテッド
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.)
Filing date
Publication date
Application filed by ロックウェル メディカル，インコーポレイテッド filed Critical ロックウェル メディカル，インコーポレイテッド
Publication of JP2018529674A publication Critical patent/JP2018529674A/ja
Publication of JP2018529674A5 publication Critical patent/JP2018529674A5/ja
Application granted granted Critical
Publication of JP7055738B2 publication Critical patent/JP7055738B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K9/1617—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)
JP2018511682A 2015-09-04 2016-09-02 固体の可溶性ピロリン酸第二鉄製剤、キット、およびそれを使用する方法 Expired - Fee Related JP7055738B2 (ja)

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 (3)

Publication Number Publication Date
JP2018529674A JP2018529674A (ja) 2018-10-11
JP2018529674A5 JP2018529674A5 (cg-RX-API-DMAC7.html) 2019-10-17
JP7055738B2 true JP7055738B2 (ja) 2022-04-18

Family

ID=56926337

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018511682A Expired - Fee Related JP7055738B2 (ja) 2015-09-04 2016-09-02 固体の可溶性ピロリン酸第二鉄製剤、キット、およびそれを使用する方法

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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000007557A (ja) 1998-06-22 2000-01-11 Lion Corp 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
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
US20120177700A1 (en) 2010-12-27 2012-07-12 Imran Mir A Nanonized Iron Compositions and Methods of Use Thereof
WO2014121155A1 (en) 2013-02-01 2014-08-07 Charak Llc Methods of treating iron deficiency with soluble ferric pyrophosphate

Family Cites Families (13)

* 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
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
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
US7816404B2 (en) * 2007-07-20 2010-10-19 Rockwell Medical Technologies, Inc. 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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000007557A (ja) 1998-06-22 2000-01-11 Lion Corp 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
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
US20120177700A1 (en) 2010-12-27 2012-07-12 Imran Mir A Nanonized Iron Compositions and Methods of Use Thereof
WO2014121155A1 (en) 2013-02-01 2014-08-07 Charak Llc Methods of treating iron deficiency with soluble ferric pyrophosphate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
新薬剤学（改訂第3版），2011.12.15，p.316, 326, 327

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
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
AU2016315877B2 (en) 2022-05-26
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

Similar Documents

Publication Publication Date Title
TWI583378B (zh) 透析酸前驅物組成物、其用途、以及提供透析酸濃縮物溶液之方法
EP1973549B1 (en) Methods and compositions for administration of iron
US11285173B2 (en) Dialysis solution, formulated and stored in two parts, comprising phosphate
JP2001513370A (ja) 水溶性ビタミン及び栄養素を含む透析溶液
JP7336993B2 (ja) 癌放射線療法を増強する組成物および方法
TWI500424B (zh) 透析前驅物組成物
KR20140026354A (ko) 경구 투여용 철의 제약 조성물
US20110052722A1 (en) Toleration Iron Supplement Compositions
JP7055738B2 (ja) 固体の可溶性ピロリン酸第二鉄製剤、キット、およびそれを使用する方法
EP2934483B1 (en) Dialysis composition
Shah et al. Novel iron-based phosphate binders in patients with chronic kidney disease
US7857977B2 (en) Packaging of ferric pyrophosphate for dialysis
CN109550053B (zh) 一种双药配位聚合物抗结核纳米药物的制备方法
HK1261642A1 (en) Solid soluble ferric pyrophosphate formulations, kits, and methods using the same
AU2014346996B9 (en) Methods of reducing doses of erythropoietin stimulating agents in hyporesponsive patients
JP6307710B2 (ja) 新規使用
JP6305156B2 (ja) 鉄代謝改善輸液剤
AU2016205002A1 (en) Methods and compositions for administration of iron
JP6169458B2 (ja) 鉄代謝改善用輸液剤
MX2008004461A (en) Improved toleration iron supplement compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190902

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190902

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200825

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20200831

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20201118

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210222

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20210806

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20211101

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20220331

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20220406

R150 Certificate of patent or registration of utility model

Ref document number: 7055738

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees