HRP20120416T1 - Postupci pripreme i uporabe smjesa kelata feri pirofosfat citrata - Google Patents

Postupci pripreme i uporabe smjesa kelata feri pirofosfat citrata Download PDF

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Publication number
HRP20120416T1
HRP20120416T1 HRP20120416AT HRP20120416T HRP20120416T1 HR P20120416 T1 HRP20120416 T1 HR P20120416T1 HR P20120416A T HRP20120416A T HR P20120416AT HR P20120416 T HRP20120416 T HR P20120416T HR P20120416 T1 HRP20120416 T1 HR P20120416T1
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Croatia
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ferric
pyrophosphate
citrate
source
amount
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HRP20120416AT
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English (en)
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William@S@@McCall@jr
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Rockwell@Medical@Technologies@Inc
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Publication of HRP20120416T1 publication Critical patent/HRP20120416T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/194Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/28Compounds containing heavy metals
    • A61K31/295Iron group metal compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287Dialysates therefor

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Dental Preparations (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

U vodi topljiva čvrsta smjesa kelata feri pirofosfat citrata koja sadrži željezo citrat pirofosfat ifosfat u količini od ili manje težinski Patent sadrži još patentna zahtjeva

Claims (23)

1. U vodi topljiva čvrsta smjesa kelata feri-pirofosfat citrata koja sadrži: željezo citrat pirofosfat; i fosfat u količini od 2% ili manje, težinski.
2. Smjesa prema zahtjevu 1, gdje je željezo prisutno u količini od 7% do 11 % težinski, citrat je prisutan u količini od 14% do 30% težinski, i pirofosfat je prisutan u količini od 10% do 20% težinski.
3. Smjesa prema zahtjevu 1, koja je topljiva u vodi u količini od najmanje po mililitru vode.
4. Smjesa prema zahtjevu 1, gdje je fosfat prisutan u količini od 1.5% ili manje, težinski.
5. Smjesa prema zahtjevu 1, gdje je fosfat prisutan u količini od 1% ili manje, težinski.
6. Smjesa prema zahtjevu 1, gdje je fosfat prisutan u količini od 0.1% ili manje, težinski.
7. Postupak pripreme u vodi topljive čvrste smjese kelata feri-pirofosfat citrata koji obuhvaća: spajanje izvora iona citrata, izvora iona pirofosfata i izvora feri iona u vodi radi dobivanja otopine; dodavanje organskog otapala u volumenu koji je dovoljan za taloženje čvrste smjese kelata feri-pirofosfat citrata iz dobivene otopine; i izoliranje čvrste smjese kelata feri-pirofosfat citrata, ta smjesa kelata sadrži 2% ili manje fosfata, težinski.
8. Postupak prema zahtjevu 7, gdje čvrsta smjesa kelata feri-pirofosfat citrata ima željezo prisutno u količini od 7% do 11% težinski, citrat je prisutan u količini od 14% do 30% težinski, i pirofosfat je prisutan u količini od 10% do 20% težinski.
9. Postupak prema zahtjevu 7, gdje su količine izvora iona citrata, izvora iona pirofosfata i izvora feri iona izabrane tako da molarni omjer feri ion: ion citrata: ion pirofosfata bude 0.9 do 1.1 : 0.9 do 1.1 : 0.45 do 0.55.
10. Postupak prema zahtjevu 7, gdje količina izvora iona citrata, izvora iona pirofosfata i izvora feri iona svaka sadrži manje od 250 mikrograma metala aluminija, antimona, arsena, bizmuta, kadmija, bakra, olova, žive, molibdena, talija i kositra po gramu izvora iona.
11. Postupak prema zahtjevu 7, gdje izvor iona pirofosfata sadrži manje od 0.1% fosfata.
12. Postupak prema zahtjevu 7, gdje izvor iona pirofosfata sadrži manje od 0.01% fosfata.
13. Postupak prema zahtjevu 7, gdje je količina vode za otapanje izvora iona citrata, izvora iona pirofosfata i izvora feri iona od 1.5 mililitara do 10 mililitara za svaki gram izvora feri iona.
14. Postupak prema zahtjevu 7, gdje se otopina zagrijava do temperature od do prije nego što se doda izvor feri iona i održava na temperaturi od do nakon što se doda izvor feri iona i dok ne dođe do potpunog otapanja izvora feri iona.
15. Postupak prema zahtjevu 14, gdje nakon što se izvor feri iona potpuno otopi, temperatura otopine se smanjuje do raspona od do radi hidrolize pirofosfata.
16. Postupak prema zahtjevu 7, gdje se organsko otapalo izabire između metanola, etanola, propanola, 2-propanola, acetonitrila, acetona, 2-butanona i kombinacija tih otapala.
17. Postupak prema zahtjevu 7, gdje se organsko otapalo dodaje u otopinu koja sadrži otopljeni izvor feri iona, otopljeni izvor iona citrata i otopljeni izvor iona pirofosfata u količini od 10 do 25 mililitara po gramu izvora feri iona.
18. Postupak prema zahtjevu 7, gdje se čvrsti kelat feri-pirofosfat citrata suši na temperaturi od ili nižoj.
19. Postupak prema zahtjevu 7, gdje se izvor feri iona izabire između feri sulfata, feri sulfat hidrata, feri klorida, feri amonij sulfata i kombinacija tih materijala; izvor iona citrata se izabire između limunske kiseline, mononatrij citrata, dinatrij citrata, trinatrij citrata i kombinacija tih materijala; i izvor iona pirofosfata se izabire između dinatrij dihidrogen pirofosfata, tetranatrij pirofosfata, i kombinacija oba ova materijala.
20. Farmaceutska smjesa koja sadrži oralni ili parenteralni dozirni oblik koji sadrži terapijski učinkovitu količinu čvrste smjese kelata feri-pirofosfat citrata s 2% ili manje fosfata, težinski.
21. Smjesa prema zahtjevu 20, koja je dijalizat.
22. Smjesa prema zahtjevu 20 ili 21 za uporabu u liječenju manjka željeza.
23. Smjesa za uporabu prema zahtjevu 22 gdje se liječenje odvija putem dijalize.
HRP20120416AT 2007-07-20 2012-05-15 Postupci pripreme i uporabe smjesa kelata feri pirofosfat citrata HRP20120416T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US96132707P 2007-07-20 2007-07-20
US12/138,018 US7816404B2 (en) 2007-07-20 2008-06-12 Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions

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HRP20120416T1 true HRP20120416T1 (hr) 2012-07-31

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US (1) US7816404B2 (hr)
EP (1) EP2016940B1 (hr)
JP (1) JP5489196B2 (hr)
AT (1) ATE554754T1 (hr)
CY (1) CY1113903T1 (hr)
DK (1) DK2016940T3 (hr)
ES (1) ES2383713T3 (hr)
HR (1) HRP20120416T1 (hr)
PL (1) PL2016940T3 (hr)
PT (1) PT2016940E (hr)
SI (1) SI2016940T1 (hr)

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Publication number Publication date
EP2016940B1 (en) 2012-04-25
ATE554754T1 (de) 2012-05-15
JP2009108027A (ja) 2009-05-21
US20090023686A1 (en) 2009-01-22
ES2383713T3 (es) 2012-06-25
CY1113903T1 (el) 2016-07-27
PT2016940E (pt) 2012-07-12
DK2016940T3 (da) 2012-06-18
JP5489196B2 (ja) 2014-05-14
SI2016940T1 (sl) 2012-07-31
PL2016940T3 (pl) 2012-09-28
US7816404B2 (en) 2010-10-19
EP2016940A1 (en) 2009-01-21

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