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DK2588488T3 - Jern (iii) caseinsuccinylat og fremgangsmåde til fremstillingen deraf - Google Patents

Jern (iii) caseinsuccinylat og fremgangsmåde til fremstillingen deraf Download PDF

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Publication number
DK2588488T3
DK2588488T3 DK10747311.8T DK10747311T DK2588488T3 DK 2588488 T3 DK2588488 T3 DK 2588488T3 DK 10747311 T DK10747311 T DK 10747311T DK 2588488 T3 DK2588488 T3 DK 2588488T3
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DK
Denmark
Prior art keywords
casein
iron
weight
iii
caseinsuccinylate
Prior art date
Application number
DK10747311.8T
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English (en)
Inventor
Andrea Stevenazzi
Ferra Lorenzo De
Barbara Pinto
Original Assignee
Italfarmaco Spa
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Publication of DK2588488T3 publication Critical patent/DK2588488T3/da

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    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/1072General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups
    • C07K1/1077General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups by covalent attachment of residues other than amino acids or peptide residues, e.g. sugars, polyols, fatty acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4732Casein

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Public Health (AREA)
  • Diabetes (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (16)

1. Jern (III) caseinsuccinylat kendetegnet ved et indhold afjern omfattende mellem 4,5 og 7 vægtprocent, ved en opløselighed større end ca. 92% og ved at have et phosphor/nitrogenforhold større end 5 vægtprocent, fortrinsvis større end ca. 5,5 vægtprocent.
2. Jern (III) caseinsuccinylat ifølge krav 1, kendetegnet ved at det indeholder en mængde proteinurenheder mindre end ca. 15 vægtprocent, fortrinsvis mindre end ca. 10 vægtprocent.
3. Fremgangsmåde til fremstilling afjern (III) caseinsuccinylat ifølge kravene 1 til 2, omfattende følgende trin: a. omsætte casein og succinsyreanhydrid i vand for at opnå succinyleret casein, b. omsætte succinyleret casein med jern (III) chlorid for at opnå jern (III) caseinsuccinylat, c. kendetegnet ved at caseinet ifølge trin a) er oprenset casein, med et proteinurenhedsindhold mindre end 15 vægtprocent og/eller uorganisk indhold af urenheder på mindre end 1 vægtprocent og/eller et phosphor-/nitrogenforhold større end 5%.
4. Fremgangsmåde ifølge krav 3, kendetegnet ved at af indholdet af proteinurenheder er mindre end ca. 10 vægtprocent og/eller det uorganiske indhold af urenheder er mindre end ca. 0,4 vægtprocent.
5. Fremgangsmåde ifølge krav 3, kendetegnet ved at proteinurenhederne er proteiner forskellige fra alfa-Sl-casein, alfa-S2-casein, betacasein, kappacasein, pseudo-kappacasein.
6. Fremgangsmåde ifølge krav 3, kendetegnet ved at det oprensede casein har et phosphor/nitrogenforhold større end ca. 5 vægtprocent.
7. Fremgangsmåde ifølge krav 3, kendetegnet ved at det oprensede casein opnås fra syrecasein eller osteløbe-casein.
8. Fremgangsmåde ifølge krav 3, omfattende et yderligere trin til mikrofiltrering af den vandige opløsning afjern (III) caseinsuccinylat.
9. Farmaceutisk sammensætning indeholdende jern (III) caseinsuccinylat ifølge kravene 1 til 2 og mindst én fysiologisk acceptabel excipiens.
10. Sammensætning ifølge krav 9, kendetegnet ved at det er i flydende eller fast form, fortrinsvis i flydende form.
11. Sammensætning ifølge krav 10, kendetegnet ved at den flydende form er en opløsning eller en suspension, fortrinsvis en vandig opløsning.
12. Sammensætning ifølge krav 9 kendetegnet ved at den flydende sammensætning er en opløsning indeholdende ca. 8 vægtprocent afjern (III) caseinsuccinylat med en viskositet mindre end ca. 400 mPa-sec, fortrinsvis mindre end ca. 300 mPa-sec.
13. Sammensætning ifølge et hvilket som helst af kravene 9 til 12, hvor jern (III) caseinsuccinylat er indeholdt ved en mængde bestående mellem 5 og 15 vægtprocent, fortrinsvis mellem 6 og 12 vægtprocent, mere fortrinsvis mellem 7 og 9 vægtprocent, i forhold til sammensætningens totalvægt.
14. Sammensætning ifølge et hvilket som helst af kravene 9 til 13 til oral eller parenteral anvendelse, fortrinsvis til oral anvendelse.
15. Sammensætning ifølge et hvilket som helst af kravene 9 til 14, til anvendelse i behandlingen af jernmangel.
16. Sammensætning til anvendelse ifølge krav 15, i behandlingen af anæmi, graviditetsjernmangel, malabsorptions-syndrom, jernmangel under amning og jernmangel under vækst.
DK10747311.8T 2010-06-30 2010-06-30 Jern (iii) caseinsuccinylat og fremgangsmåde til fremstillingen deraf DK2588488T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2010/000287 WO2012001712A1 (en) 2010-06-30 2010-06-30 Iron (iii) caseinsuccinylate and method for the preparation thereof

Publications (1)

Publication Number Publication Date
DK2588488T3 true DK2588488T3 (da) 2017-04-03

Family

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DK10747311.8T DK2588488T3 (da) 2010-06-30 2010-06-30 Jern (iii) caseinsuccinylat og fremgangsmåde til fremstillingen deraf

Country Status (20)

Country Link
US (1) US20130102529A1 (da)
EP (1) EP2588488B1 (da)
KR (1) KR101701830B1 (da)
CN (2) CN103025751B (da)
AR (1) AR122394A2 (da)
BR (1) BR112012032364B1 (da)
CY (1) CY1119054T1 (da)
DK (1) DK2588488T3 (da)
ES (1) ES2628306T3 (da)
HR (1) HRP20170541T1 (da)
HU (1) HUE032746T2 (da)
LT (1) LT2588488T (da)
MA (1) MA34319B1 (da)
MX (1) MX346317B (da)
PL (1) PL2588488T3 (da)
PT (1) PT2588488T (da)
RS (1) RS55978B1 (da)
RU (1) RU2533826C2 (da)
SI (1) SI2588488T1 (da)
WO (1) WO2012001712A1 (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102836419B (zh) * 2012-09-25 2014-06-25 济川药业集团有限公司 一种蛋白琥珀酸铁口服溶液及其制备方法
CN108498454B (zh) * 2018-04-03 2020-11-06 济川药业集团有限公司 一种蛋白琥珀酸铁口服液及其制备方法
CN111000977A (zh) * 2019-03-22 2020-04-14 江苏中天药业有限公司 一种蛋白琥珀酸铁固体新剂型及其制备方法
CN112063676B (zh) * 2020-09-02 2021-11-12 杭州汉库医药科技有限公司 酪蛋白纯化方法和蛋白琥珀酸铁的制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1150213B (it) 1982-03-02 1986-12-10 Italfarmaco Spa Derivati di ferro biodisponibile esenti da gastrolesivita',procentimento di preparazione e relative composizioni farmaceutiche
IT1222912B (it) 1987-10-14 1990-09-12 Italfarmaco Spa Derivati polipeptidici a elevato tenore di ferro e altamente solubili atti alla terapia marziale procedimenti di preparazione e loro forme farmaceutiche
IT1297022B1 (it) * 1997-12-24 1999-08-03 Chemi Spa Complesso di ferro-succinilcaseina, processo per la sua preparazione e composizioni farmaceutiche che lo contengono
ITMO20040200A1 (it) * 2004-07-29 2004-10-29 Biofer Spa Processo per la produzione di complessi ferro succinilcaseina e ferro casein acetil aspartilato e loro utilizzato nelle relative composizioni farmaceutiche.
NZ568332A (en) * 2005-12-06 2010-11-26 Vifor Int Ag Process for the preparation of ferri-succinylcasein
WO2007143088A2 (en) * 2006-06-02 2007-12-13 Abbott Laboratories Protein ingredient with improved sensory quality and nutritionals with improved flavor containing same
TWI346666B (en) * 2007-12-31 2011-08-11 Animal Technology Inst Taiwan Method for seperating casein from casein-contained solution

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Publication number Publication date
RU2013103799A (ru) 2014-08-10
MX346317B (es) 2017-03-15
KR101701830B1 (ko) 2017-02-13
RS55978B1 (sr) 2017-09-29
LT2588488T (lt) 2017-05-10
BR112012032364A2 (pt) 2016-10-04
HUE032746T2 (en) 2017-10-30
HRP20170541T1 (hr) 2017-06-16
CY1119054T1 (el) 2018-01-10
MA34319B1 (fr) 2013-06-01
CN103025751B (zh) 2016-12-21
PT2588488T (pt) 2017-06-26
CN107090011A (zh) 2017-08-25
KR20130136422A (ko) 2013-12-12
AR122394A2 (es) 2022-09-07
RU2533826C2 (ru) 2014-11-20
CN103025751A (zh) 2013-04-03
MX2012014199A (es) 2013-05-06
SI2588488T1 (sl) 2017-07-31
WO2012001712A1 (en) 2012-01-05
EP2588488A1 (en) 2013-05-08
EP2588488B1 (en) 2017-03-15
ES2628306T3 (es) 2017-08-02
BR112012032364B1 (pt) 2021-08-31
PL2588488T3 (pl) 2017-09-29
US20130102529A1 (en) 2013-04-25

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