GB1076219A - Parenteral iron preparations - Google Patents

Parenteral iron preparations

Info

Publication number
GB1076219A
GB1076219A GB4635665A GB4635665A GB1076219A GB 1076219 A GB1076219 A GB 1076219A GB 4635665 A GB4635665 A GB 4635665A GB 4635665 A GB4635665 A GB 4635665A GB 1076219 A GB1076219 A GB 1076219A
Authority
GB
United Kingdom
Prior art keywords
mol
complex
solution
iron
carbohydrate
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
Application number
GB4635665A
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vifor International AG
Original Assignee
Laboratorien Hausmann AG
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 Laboratorien Hausmann AG filed Critical Laboratorien Hausmann AG
Publication of GB1076219A publication Critical patent/GB1076219A/en
Expired legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H23/00—Compounds containing boron, silicon, or a metal, e.g. chelates, vitamin B12
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F15/00—Compounds containing elements of Groups 8, 9, 10 or 18 of the Periodic System
    • C07F15/02—Iron compounds
    • C07F15/025—Iron compounds without a metal-carbon linkage
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B31/00—Preparation of derivatives of starch
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof

Abstract

A non-ionic iron-carbohydrate complex is formed of 1 mol. of ferric hydroxide and 1 mol. of a complex-forming agent consisting of a mixture of sorbitol (about 0.4 mol.), gluconic acid (about 0.3 mol.) and a polyglucose (about 0.3 mol.), the polyglucose comprising dextrin, dextran, hydrogenated dextrin or hydrogenated dextran having intrinsic viscosity 0.01-0.025 at 25 DEG C., and average molecular weights 500-1200. The hydrogenated polyglucoses are substantially non-reducing to Somogyi reagent. The complex is made by treating 1 mol. of a trivalent iron compound in aqueous solution with about 2 mols. of complex-forming agent having the molar ratio of sorbitol: gluconic acid: polyglucose about 1.15: 0.40: 0.5, and heating the mixture at an alkalene pH. In one embodiment, aqueous solutions of ferric chloride and alkali are added to an aqueous solution of carbohydrate at 60 DEG C., and the reaction mixture (pH 9-9.5) heated to boiling for 5-30 minutes. Alternatively, a carbohydrate solution and alkali are added to an aqueous suspension of freshly-precipitated ferric hydroxide. In a further embodiment, an acid-complex is made by adding to aqueous ferric chloride, at room temperature, aqueous carbohydrate solution and sufficient sodium carbonate or bicarbonate solution to produce a pH of 2.5, increasing the pH to about 9.5 by addition of sodium hydroxide and heating to boiling. The complex is isolated by precipitation from the cooled and neutralized solution. The complex may contain 21-26% iron and aqueous solutions containing 5-10% iron may be formed therefrom for therapeutic use (Divisions A5-A6). The hydrogenation of dextrin is described.ALSO:A non-ionic iron-carbohydrate complex is formed of 1 mol of ferric hydroxide and 1 mol of a complex-forming agent consisting of a mixture of sorbitol (about 0.4 mol), gluconic acid (about 0.3 mol) and a polyglucose (about 0.3 mol), the polyglucose comprising dextrin, dextran, hydrogenated dextrin or hydrogenated dextran having intrinsic viscosity 0.01-0.025 at 25 DEG C., and average molecular weights 500-1200. The hydrogenated polyglucoses are substantially non-reducing to Somogyi reagent. The complex is made by treating 1 mol of a trivalent iron compound in aqueous solution with about 2 mols of complex-forming agent having the molar ratin of sorbitol : gluconic acid : polyglucose about 1.15:0.40:0.5, and heating the mixture at an alkaline pH. In one embodiment, aqueous solutions of ferric chloride and alkali are added to an aqueous solution of carbohydrate at 60 DEG C., and the reaction mixture (pH 9-9.5) heated to boiling for 5-30 minutes. Alternatively, a carbohydrate solution and alkali are added to an aqueous suspension of freshly-precipitated ferric hydroxide. In a further embodiment, an acid-complex is made by adding to aqueous carbohydrate solution and sufficient sodium carbonate or bicarbonate solution to produce a pH of 2.5, increasing the pH to about 9.5 by addition of sodium hydroxide and heating to boiling. The complex is isolated by precipitation from the cooled and neutralized solution. The complex may contain 21-26% iron and aqueous solutions containing 5-10% iron may be formed therefrom for therapeutic use (Division A5-A6). The hydrogenation of dextrin is described.ALSO:A therapeutic iron preparation comprises an aqueous solution of a non-ionic iron-carbohydrate complex formed of 1 mol of ferric hydroxide and 1 mol of a complex-forming agent consisting of a mixture of sorbitol (about 0.4 mol), gluconic acid (about 0.3 mol) and a poly glucose (about 0.3 mol), the poly-glucose comprising dextrin, dextran, hydrogenated dextrin or hydrogenated dextran having intrinsic viscosity 0.01-0.25 at 25 DEG C and average molecular weight 500-1200. The solution, which may contain 5-10% iron, are administered by intramuscular injection.
GB4635665A 1964-11-04 1965-11-02 Parenteral iron preparations Expired GB1076219A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DEL49194A DE1293144B (en) 1964-11-04 1964-11-04 Process for the production of complex compounds of iron with sorbitol, gluconic acid and an oligosaccharide

Publications (1)

Publication Number Publication Date
GB1076219A true GB1076219A (en) 1967-07-19

Family

ID=7272836

Family Applications (1)

Application Number Title Priority Date Filing Date
GB4635665A Expired GB1076219A (en) 1964-11-04 1965-11-02 Parenteral iron preparations

Country Status (7)

Country Link
CH (1) CH475007A (en)
DE (1) DE1293144B (en)
DK (1) DK116688B (en)
ES (1) ES319085A1 (en)
GB (1) GB1076219A (en)
IL (1) IL24513A (en)
NL (1) NL6514241A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK172860B1 (en) * 1998-03-25 1999-08-16 Pharmacosmos Holding As Iron dextran compound for use as a component of a therapeutic agent for the prevention or treatment of iron man
WO2003087164A1 (en) * 2002-04-09 2003-10-23 Pharmacosmos Holding A/S Iron dextrin compounds for the treatment of iron deficiency anaemia
WO2005111052A1 (en) * 2004-05-17 2005-11-24 Cilag Ag Method for producing iron (iii) gluconate complex
JP2012521369A (en) * 2009-03-25 2012-09-13 ファーマコスモス ホールディング エー／エス Stable iron oligosaccharide compounds
EP2997968A1 (en) 2014-09-22 2016-03-23 Ioulia Tseti Iron (III) hydroxide complexes with activated glucose syrups and process for preparing same

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6039681B2 (en) * 1976-01-01 1985-09-07 日本臓器製薬株式会社 Dextrin-citric acid-ferric polynuclear complex and parenteral iron preparation containing the complex
HU187167B (en) * 1982-10-15 1985-11-28 Richter Gedeon Vegyeszet Process for producing pharmaceutical solution of new type polynuclear iron/iii/ mixed complex activity

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1172250B (en) * 1958-02-13 1964-06-18 Hausmann Ag Labor Process for the production of therapeutically usable iron (ó¾) -dextran complex compounds
CH366537A (en) * 1958-02-13 1963-01-15 Hausmann Ag Labor Process for the preparation of a therapeutically applicable iron-polyisomaltosate complex

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK172860B1 (en) * 1998-03-25 1999-08-16 Pharmacosmos Holding As Iron dextran compound for use as a component of a therapeutic agent for the prevention or treatment of iron man
WO1999048533A1 (en) * 1998-03-25 1999-09-30 Pharmacosmos Holding A/S An iron-dextran compound for use as a component in a therapeutical composition for prophylaxis or treatment of iron-deficiency, a process for producing said iron-dextran compound and use of said compound for the preparation of a parenterally administrable therapeutical composition
US6291440B1 (en) 1998-03-25 2001-09-18 Pharmacosmos Holding A/S Iron-dextran compound for use as a component in a therapeutical composition for prophylaxis or treatment of iron-deficiency
EA003427B1 (en) * 1998-03-25 2003-04-24 Фармакосмос Холдинг А/С An iron-dextran compound for use as a component in a therapeutical composition for prophylaxis or treatment of iron-deficiency, a process for producing said iron-dextran compound and use of said compound for the preparation of a parenterally administrable therapeutical composition
KR100612071B1 (en) * 1998-03-25 2006-08-11 파르마코스모스 홀딩 에이/에스 An iron-dextran compound for use as a component in a therapeutical composition for prophylaxis or treatment of iron-deficiency, a process for producing said iron-dextran compound and use of said compound for the preparation of a parenterally administrable therapeutical composition
WO2003087164A1 (en) * 2002-04-09 2003-10-23 Pharmacosmos Holding A/S Iron dextrin compounds for the treatment of iron deficiency anaemia
JP2005530863A (en) * 2002-04-09 2005-10-13 ファーマコスモス、ホールディング、アクティーゼルスカブ Iron dextrin compounds for the treatment of iron deficiency anemia
CN1309741C (en) * 2002-04-09 2007-04-11 法玛科思莫斯控股有限公司 Iron dextrin compounds for the treatment of iron deficiency anaemia
WO2005111052A1 (en) * 2004-05-17 2005-11-24 Cilag Ag Method for producing iron (iii) gluconate complex
AU2004319676B2 (en) * 2004-05-17 2011-01-06 Cilag Ag Method for producing iron (III) gluconate complex
JP2012521369A (en) * 2009-03-25 2012-09-13 ファーマコスモス ホールディング エー／エス Stable iron oligosaccharide compounds
US8815301B2 (en) 2009-03-25 2014-08-26 Pharmacosmos Holding A/S Stable iron oligosaccharide compound
US9439969B2 (en) 2009-03-25 2016-09-13 Pharmacosmos Holding A/S Stable iron oligosaccharide compound
EP3156075A1 (en) 2009-03-25 2017-04-19 Pharmacosmos Holding A/S An oligosaccharide and a process for preparation thereof
US10414831B2 (en) 2009-03-25 2019-09-17 Pharmacosmos Holding A/S Stable iron oligosaccharide compound
US10865255B2 (en) 2009-03-25 2020-12-15 Pharmacosmos Holding A/S Stable iron oligosaccharide compound
EP3821910A1 (en) 2009-03-25 2021-05-19 Pharmacosmos Holding A/s An oligosaccharide and a process for preparation thereof
US11851504B2 (en) 2009-03-25 2023-12-26 Pharmacosmos Holding A/S Stable iron oligosaccharide compound
EP2997968A1 (en) 2014-09-22 2016-03-23 Ioulia Tseti Iron (III) hydroxide complexes with activated glucose syrups and process for preparing same
EP3583941A1 (en) 2014-09-22 2019-12-25 Ioulia Tseti Iron (iii) hydroxide complexes with activated glucose syrups and process for preparing same

Also Published As

Publication number Publication date
ES319085A1 (en) 1966-04-16
IL24513A (en) 1969-06-25
CH475007A (en) 1969-07-15
DE1293144B (en) 1969-04-24
NL6514241A (en) 1966-05-05
DK116688B (en) 1970-02-02

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