Iron dextrin compounds for the treatment of iron deficiency anaemia

A technology of iron dextrin and compound, applied in the field of new iron dextrin compound

Inactive Publication Date: 2005-07-27
PHARMACOSMOS HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although direct evidence has not been provided, it is hypothesized that iron is dissolved by the acidic medium of the stomach, mixed with sugars from hydrolyzed dietary starches, and transported to the small intestine where the sugar- and iron-rich food mass is neutralized to form Iron Soluble Carbohydrate Complex

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Hydrolysis and Hydrogenation of Dextrin

[0079] Dextrin formed by hydrolyzing gelatin with Mw > 3000 at a temperature of 95°C at pH 1.5. The reaction was monitored by taking samples and analyzing them chromatographically using gel permeation chromatography.

[0080] When the molecular weight of dextrin reaches the ideal value, that is, the weight average molecular weight is lower than 3000Da, the hydrolysis is terminated by cooling and neutralization.

[0081] By hydrolysis, low molecular weight dextrins and glucose are formed.

[0082] The cooled and neutralized dextrin solution is subjected to a membrane purification process with a cut-off value of 340-800 Da in order to remove glucose and smaller dextrins formed during hydrolysis, followed by determination of the dextrin content with a refractometer and oxidation with copper Determination of reducing sugars.

[0083] The reducing power (RC) was reduced by treatment with sodium borohydride. After treatment with s...

Embodiment 2

[0086] Preparation of iron dextrin compound

[0087] A kg dextrin solution produced as above was mixed with B kg FeCl in aqueous solution 3 ·6H 2 O mix. To the stirred mixture was added C kg Na as a saturated aqueous solution 2 CO 3 , followed by raising the pH to 10.0 with concentrated aqueous NaOH (27% w / v) (approximately 251).

[0088] The mixture thus obtained is heated above 85° C. until it turns into a black or dark brown colloidal solution, which can be filtered through a 0.45 μm filter and subsequently cooled. After cooling, the solution was adjusted to pH 5.8 with concentrated hydrochloric acid (ca. 2-5 l). The solution was purified using a membrane method until the chlorine content in the solution was below 0.15%, calculated on the basis of a solution containing 5% w / v iron.

[0089] If the chlorine content of the solution is lower than the desired sodium chloride addition, adjust the pH to 5.6 with hydrochloric acid or sodium hydroxide and filter the solution ...

Embodiment 3

[0093] Preparation of iron dextrin citrate compound

[0094] A kg dextrin solution prepared as in Example 1 was mixed with B kg FeCl in aqueous solution 3 ·6H 2 O mix. To the stirred mixture was added C kg Na as a saturated aqueous solution 2 CO 3 , followed by raising the pH to 10.0 with concentrated aqueous NaOH (27% w / v) (approximately 251).

[0095] The mixture thus obtained is heated above 85° C. until it turns into a black or dark brown colloidal solution, which can be filtered through a 0.45 μm filter and subsequently cooled. After cooling, the solution was adjusted to pH 5.8 with concentrated hydrochloric acid (ca. 2-5 l). The solution was purified using a membrane method until the chlorine content in the solution was below 0.15%, calculated on the basis of a solution containing 5% w / v iron.

[0096] Citrate was added in an amount D kg and the pH was adjusted to above 8.0 with sodium hydroxide and the solution was stabilized by raising the temperature above 100°C...

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Abstract

An iron-dextrin compound for treatment of iron deficiency anaemia comprising hydrogenated dextrin having a weight average molecular weight equal to or less than 3,000 Dalton and a number average molecular weight equal to or higher than 400 Daltons, in stable association with ferric oxyhydroxide. As the molecular weight of the dextrin must be narrow it is another important feature of the invention that the 10% fraction of the dextrins having the highest molecular weight has an average molecular weight of less than 4500 Daltons, and that 90% of the dextrins are having molecular weights of less than 3000 Daltons. It is further important that the 10% fraction having the lowest molecular weight has a weight average molecular weight of 340 Daltons or more.

Description

[0001] The present invention relates to novel iron dextrin compounds and to a process for their preparation. The present invention further relates to the application of iron dextrin in the preparation of a pharmaceutical composition for treating iron deficiency anemia in humans or livestock. Background of the invention [0002] Globally, iron deficiency anemia has been described as one of the most prevalent human pathological conditions, possibly the most prevalent human pathological condition. Iron deficiency anemia is also a problem in pigs and other domesticated animals raised on modern farms unless proper precautions are taken. [0003] Although iron deficiency anemia can usually be prevented or cured by oral administration of preparations containing iron, in many cases it is preferable to use parenterally administrable iron preparations to avoid changes in the bioavailability of oral administration and to ensure effective administration. medicine. [0004] Accordingly, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/715A61K33/26A61K45/00A61K47/12A61K47/48A61P7/06C08B30/18
CPCA61K33/26A61K31/715C08B30/18A61P7/00A61P7/06A61K2300/00
Inventor H·B·安得里森L·克里斯坦森
Owner PHARMACOSMOS HLDG
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