HK1149574B - Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes - Google Patents

Description

The present invention relates to water-soluble iron-carbohydrate complexes suitable for the treatment of iron deficiency anaemias, their manufacture, medicinal products containing them and their use in the prophylaxis or treatment of iron deficiency anaemias.

Iron deficiency anemia can be treated or prevented by the administration of iron-containing medicinal products. For this purpose, iron-carbohydrate complexes are known to be used. A commonly used and successful preparation is a water-soluble iron ((III) hydroxide-sucrose complex (Danielson, Salmonson, Derendorf, Geisser, Drug Res., Vol. 46: 615-621, 1996).

GB 1111929 provides a method for the production of colloidal iron preparations; DE 3443251 provides a diagnostic tool for use in NMR diagnostics containing ferromagnetic complexes; US 3821192 provides a method for the production of complexes of iron and dextrin, maltose or glucose; US 3086009 provides a method for the production of an iron complex with hydrolyzed starch; CH 423744 provides a method for the production of iron complex compounds with oxidized dextrins not described in detail.

The present invention is intended to provide a preferred parenteral iron preparation which is relatively easy to sterilize, since the previous parenteral iron preparations based on sucrose or dextran were stable only at temperatures up to 100°C, making sterilization difficult. In addition, the preparation to be delivered in accordance with the invention is intended to have a reduced toxicity and to avoid the dangerous anaphylactic shocks induced by dextran. The preparation to be delivered is also intended to have a high complexity stability, allowing a high dose of preparation or a high speed of application. The iron preparation is also intended to be readily available without special equipment.

This problem has been shown to be solved by water-soluble iron (III) carbohydrate complexes with a mean molecular weight Mw of 80 kDa to 400 kDa on the basis of the oxidation products of maltodextrins. The object of the invention is therefore water-soluble iron-carbohydrate complexes obtained from an aqueous iron (III) salt solution and an aqueous solution of the product of oxidation of one or more maltodextrins with an aqueous hypochlorite solution at an alkaline pH of e.g. 8 to 12, whereby the use of a maltodextrin dextrose equivalent of 5 to 20 and the use of a compound containing a maltodextrin dextrose equivalent of 5 to 20 is involved in the production of the product of oxidation of one or more maltodextrins with an aqueous hypochlorite solution at an alkaline pH of e.g. 8 to 12, whereby the dextrose equivalent of the maltodextrin is 5 to 20 and the dextrose equivalent of the maltodextrine is 2 to 40 at the level of the individual maltodextrine.

The invention also relates to a process for the preparation of the iron-carbon complexes of the invention, in which one or more maltodextrins are oxidized in aqueous solution at an alkaline pH of, for example, 8 to 12 by an aqueous hypochlorite solution and the resulting solution is incorporated in the aqueous solution of an iron (III) salt, whereby the dextrose equivalent of a maltodextrin is 5 to 20 and the dextrose equivalent of the mixture is 5 to 20 and the dextrose equivalent of the individual maltodextrins involved in the mixture is 2 to 40 when a maltodextrin is used and a mixture of several maltodextrins is used.

The maltodextrins used are readily available starting products which are commercially available.

For the preparation of the ligands of the complexes of the invention, the maltodextrins are oxidized in aqueous solution with hypochlorite solution. For example, solutions of alkali hypochlorites, such as sodium hypochlorite solution, are suitable. Commercial solutions may be used. The concentrations of the hypochlorite solutions are, for example, at a minimum of 13% by weight, preferably in the range of 13 to 16% each calculated as active chlorine. The solutions are preferably used in such a quantity that about 80 to 100%, preferably about 90% of an aldehyde group per maltodextrin molecule is oxidized. In this way, the amount of glycerin produced by the maltodextrin reduces to about 20% or 10% or less, or is reduced to about 10%.

The oxidation is carried out in an alkaline solution, for example at pH values of 8 to 12, e.g. 9 to 11.

The method described herein aims to keep the degree of depolymerisation of the maltodextrins used to a minimum.

It is also possible to catalyze the oxidation reaction of the maltodextrins. The addition of bromidiones, e.g. in the form of alkali bromides, e.g. sodium bromide, is suitable. The amount of bromide added is not critical. It is kept as low as possible to obtain an end product (Fe complex) that is as easy to clean as possible. Catalytic amounts are sufficient.

In addition, it is possible, for example, to use the known ternary oxidation system hypochlorite/alkalibomide/2,2,6,6-tetramethylpiperidine-1-oxyl (TEMPO) to oxidize maltodextrin. The method of oxidation of maltodextrin by catalysis of alkali bromides or by the ternary TEMPO system is described, for example, by Thaburet et al. in Carbohydrate Research 330 (2001) 21-29 and the method described therein is applicable according to the invention.

To produce the complexes of the invention, the oxidized maltodextrins obtained are converted into an aqueous solution with an iron (III) salt, for which purpose the oxidized maltodextrins can be isolated and reconstituted; however, the aqueous solutions of the oxidized maltodextrins obtained can also be used directly for further processing with aqueous iron (III) solutions.

Iron (III) salts may be water-soluble salts of inorganic or organic acids or mixtures thereof, such as halogenides, e.g. chloride and bromide, or sulfates.

The presence of chloridiones has been shown to favour the formation of complexes, which can be added, for example, in the form of water-soluble chlorides such as alkali metal chlorides, e.g. sodium chloride, potassium chloride or ammonium chloride.

For example, for implementation, the aqueous solution of oxidised maltodextrin can be mixed with an aqueous solution of iron (III) salt. This is preferably done in such a way that the pH of the mixture of oxidized maltodextrin and iron (III) salt is initially highly acidic or so low that no hydrolysis of the iron (III) salt occurs, e.g. 2 or below, to avoid an undesirable precipitation of iron oxides. When using iron (III) coride, neutral acid is generally not required, as solutions of oxidized maltodextrin and iron (III) salt are obtained from iron (III) oxide, or from potassium (C) oxide, or from potassium (III) oxide. This can be achieved by adding a pH of 11, or an alkaline base, such as sodium or sodium, or sodium or sodium carbonate, which can be elevated to a pH of 12 or higher, for example, or by adding a base of sodium or sodium carbonate, such as sodium or sodium carbonate, which can be added to a base of sodium or sodium carbonate, or sodium carbonate, or sodium carbonate, which can be added to a base of sodium or sodium or sodium carbonate, or sodium carbonate, for example, or sodium or sodium or sodium or sodium carbonate, which can be added to a base of sodium or sodium or sodium or sodium carbonate, which is elevated to a base of 11, or sodium or sodium or sodium or sodium or sodium carbon, which can be added to a base of sodium or sodium or sodium or sodium.

The implementation can be facilitated by heating. For example, temperatures in the range of 15°C to boiling temperature can be used. It is preferable to increase the temperature gradually. For example, it can be heated to about 15 to 70°C first and gradually increased to boiling.

For example, reaction times range from 15 minutes to several hours, e.g. 20 minutes to 4 hours, e.g. 25 to 70 minutes, e.g. 30 to 60 minutes.

The implementation can be carried out in the weakly acidic range, for example at pH values in the range of 5 to 6, but it has been shown that it is useful, although not necessary, to raise the pH to higher levels, up to 11, 12, 13 or 14, during complex formation. To complete the reaction, the pH can then be further reduced by acid addition, for example to the above-mentioned range of 5 to 6.

As mentioned, the formation of complexes is generally facilitated by heating; for example, in the preferred embodiment, where the pH is increased to 11 or 14 over the course of the implementation to a range of more than 5, work may be done first at low temperatures in the range of 15 to 70°C, e.g. 40 to 60°C, e.g. about 50°C, and then after further reduction of the pH, e.g. to values in the range of at least 5, gradually heated to temperatures above 50°C to boiling.

The reaction times are on the order of 15 minutes to several hours and may vary according to the reaction temperature. For example, when the process is carried out with intermediate application of pH values above 5, 15 to 70 minutes, e.g. 30 to 60 minutes at elevated pH, e.g. up to 70°C, may be worked, after which the reaction may be carried out to boil for at least 15 to 70 minutes, e.g. 30 to 60 minutes at temperatures up to, for example, 70°C and, where appropriate, another 15 to 70 minutes, e.g. 30 to 60 minutes at higher temperatures, after the pH has been reduced to the range of 5.

After implementation, the resulting solution may be cooled to room temperature, and if necessary diluted and filtered. After cooling, the pH can be adjusted to the neutral point or slightly below, for example, to values of 5 to 7, by adding acid or base. The acids or bases mentioned above may be used as the basis for implementation, for example. The resulting solutions are cleaned and can be used directly to manufacture medicines.

The resulting iron (III) carbohydrate complexes, for example, have an iron content of 10 to 40% by weight, and in particular 20 to 35% by weight. They are well water-soluble. They can be used to make neutral aqueous solutions with, for example, an iron content of 1 to 20% by weight. These solutions can be thermally sterilized. The mean molecular weight of the resulting complexes is 80 kDa to 400 kDa, preferably 80 to 350 kDa, and preferably up to 300 kDa (determined by gel permeation cathography, e.g. by Geisser et al. in Pharmaceuticals/Drug Resolution 42 (II), paragraphs 14.39 to 14.42 (1995) and 2.2.22).

As mentioned, the complexes of the invention can be used to make aqueous solutions. These are particularly suitable for parenteral application, but they can also be used orally or topically. Unlike the previously common parenteral iron solutions, they can be sterilised at high temperatures, e.g. 121°C and above, with short contact times of, for example, about 15 minutes below Fo 15. At higher temperatures, the contact times are shorter accordingly. Previously known preparations have had to be sterilized at room temperature and partially infused with preservatives such as phenyl alcohol or benzyl alcohol. The usual formulations are not to be administered by injection.

The invention therefore also relates to the use of the iron (III) carbohydrate complexes of the invention for the treatment and prophylaxis of iron deficiency anaemia or for the manufacture of medicinal products for the parenteral treatment of iron deficiency anaemia. The medicinal products are suitable for use in human and veterinary medicine.

The advantages of the iron-carbohydrate complexes of the invention are the high sterilization temperatures mentioned above, which are accompanied by low toxicity and a reduced risk of anaphylactic shock. The toxicity of the complexes of the invention is very low. The LD50 is above 2000 mg Fe/kg compared to the LD50 of the known pullulane complexes, which is 1400 mg Fe/kg. The high stability of the complexes of the invention allows the industry to increase the application rate and also the D-value. This allows the invention to be widely used as a single-dose drug. For example, it can be used as a starting drug in products with a dosage of up to 500 mg iron per hour.

In the present description and the following examples, dextrose equivalents are gravimetrically determined. For this purpose, the maltodextrins are converted into an aqueous solution with Fehling's solution under boiling. The conversion is quantitative, i.e. until no further discoloration of the Fehling's solution occurs. The precipitated copper ((I) oxide) is dried at 105 °C to weight consistency and gravimetrically determined. The glucose content (dextrose equivalent) is calculated as %/w of the maltodextrin triac acid. For example, the following solutions can be used: 25 ml of Fehling's solution I, dissolved in 25 ml of Fehling's solution; 10 ml of Maltodextrin II, dissolved in water (10 ml of water; 100 ml of sodium sulphate) and 173 ml of Sulphuric acid (10 ml of sodium sulphate): 400 g/mol (solved in water): 34.6 ml of Maltodextrin II, dissolved in water (10 ml of sodium sulphate) and 50 ml of Sulphuric acid (10 ml of sodium sulphate).

Example 1

Dissolve 100 g maltodextrin (9,6 dextrose equivalents, determined by gravimetric method) in 300 ml of water at 25°C by stirring and oxidise by adding 30 g of sodium hypochlorite solution (13 to 16% by weight of active chlorine) at pH 100.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltodextrin solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to set the pH to 11, heating the solution to 50°C and keeping it at 50°C for 30 minutes, acidifying the solution to 5 to 6 by adding hydrochloric acid, keeping the solution at 50°C for another 30 minutes, heating it to 97 to 98°C and keeping it at this temperature for 30 minutes, and cooling the solution to room temperature, setting the pH to 6-7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

125 g (87% by weight) of a brown, amorphous powder with an iron content of 29.3% by weight (complexometrically determined) is obtained.

Molecular weight Mw 271 kDa

Example 2

200 g maltodextrin (9,6 dextrose equivalents, determined by gravimetric method) are dissolved in 300 ml of water at 25°C by stirring and oxidised by adding 30 g of sodium hypochlorite solution (13 to 16% by weight of active chlorine) at pH 10.

To 352 g of iron (III) chloride solution (12 g/g Fe) the oxidized maltodextrin solution and then 554 g of sodium carbonate solution (17.3% g/g Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to set the pH to 11, heating the solution to 50°C and keeping it at 50°C for 30 minutes, acidifying the solution to 5 to 6 by adding hydrochloric acid, keeping the solution at 50°C for another 30 minutes, heating it to 97 to 98°C and keeping it at this temperature for 30 minutes, and cooling the solution to room temperature, setting the pH to 6-7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

123 g (65 °/d) of a brown amorphous powder with an iron content of 22,5% by weight (complexometrically determined) are obtained.

Molecular weight Mw 141 kDa

Example 3

Dissolve 100 g maltodextrin (9,6 dextrose equivalents, determined by gravimetric method) in 300 ml of water at 25°C by stirring and oxidise by adding 30 g of sodium hypochlorite solution (13 to 16% by weight of active chlorine) and 0,7 g of sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/g Fe) the oxidized maltodextrin solution and then 554 g of sodium carbonate solution (17.3% g/g Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to a pH of 6.5, heating to 50°C and keeping the solution at 50°C for 60 minutes, acidifying to a pH of 5 to 6 by adding hydrochloric acid, heating to 50°C for another 30 minutes, heating to 97 to 98°C and keeping the solution at this temperature for 30 minutes, and cooling the solution to room temperature, setting the pH to 6-7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

139 g (88% by weight) of a brown, amorphous powder with an iron content of 26.8% by weight (complexometrically determined) is obtained.

Molecular weight Mw 140 kDa

Example 4

A mixture of 45 g maltodextrin (6,6 dextrose equivalents, gravimetrically determined) and 45 g maltodextrin (14,0 dextrose equivalents, gravimetrically determined) is dissolved at 25 °C under stirring in 300 ml of water and oxidised by addition of 25 g of sodium hypochlorite solution (13 to 16% by weight active chlorine) and 0,6 g of sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltose solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then add baking soda to a pH of 11, heat the solution to 50°C and maintain it at 50°C for 30 minutes, acidify the solution to a pH of 5 to 6 by adding hydrochloric acid, maintain the solution at 50°C for another 30 minutes, then heat it to 97 to 98°C and maintain it at this temperature for 30 minutes, and after cooling the solution to room temperature, adjust the pH to 6 to 7 by adding baking soda,

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

143 g (90%) of a brown, amorphous powder with an iron content of 26.5% by weight (complexometrically determined) is obtained.

Molecular weight Mw 189 kDa

Example 5

90 g maltodextrin (14.0 dextrose equivalents, determined by gravimetric method) is dissolved in 300 ml of water at 25°C by stirring and oxidised by adding 35 g of sodium hypochlorite solution (13 to 16% by weight of active chlorine) and 0.6 g of sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltose solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then add baking soda to a pH of 11, heat the solution to 50°C and maintain it at 50°C for 30 minutes, then acidify the solution to a pH of 5 to 6 by adding hydrochloric acid, heat the solution at 50°C for another 30 minutes, then heat it to 97 to 98°C and maintain it at this temperature for 30 minutes.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

131 g (93% by weight) of a brownish amorphous powder with an iron content of 29.9% by weight (complexometrically determined) is obtained.

Molecular weight Mw 118 kDa

Example 6

A mixture of 45 g maltodextrin (5,4 dextrose equivalents, gravimetrically determined) and 45 g maltodextrin (18,1 dextrose equivalents, gravimetrically determined) is dissolved at 25 °C in 300 ml of water by stirring and oxidised by adding 31 g of sodium hypochlorite solution (13 to 16% by weight active chlorine) and 0,7 g of sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltose solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to set the pH to 11, heating the solution to 50°C and keeping it at 50°C for 30 minutes, acidifying the solution to 5 to 6 by adding hydrochloric acid, keeping the solution at 50°C for another 30 minutes, heating it to 97 to 98°C and keeping it at this temperature for 30 minutes, and cooling the solution to room temperature, setting the pH to 6 to 7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

134 g (88% by weight) of a brown amorphous powder with an iron content of 27.9% by weight (complexometrically determined) are obtained.

Molecular weight Mw 1 78 kDa

Example 7

Dissolve 100 g maltodextrin (9,6 dextrose equivalents, determined by gravimetric method) in 300 ml of water at 25°C by stirring and oxidise by adding 29 g of sodium hypochlorite solution (13 to 16% by weight of active chlorine) and 0,7 g of sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltose solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to set the pH to 11, heating the solution to 50°C and keeping it at 50°C for 30 minutes, acidifying the solution to 5 to 6 by adding hydrochloric acid, keeping the solution at 50°C for another 70 minutes, and cooling the solution to room temperature, setting the pH to 6 to 7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

The result is 155 g (90%) of a brown, amorphous powder with an iron content of 24.5% by weight (complexometrically determined).

Molecular weight Mw 137 kDa

Example 8

Dissolve 126 g maltodextrin (6.6 dextrose equivalents, determined by gravimetric method) in 300 ml of water at 25°C by stirring and oxidise by adding 24 g sodium hypochlorite solution (1-3 to 16% by weight of active chlorine) and 0.7 g sodium bromide at pH 10.

To 352 g of iron (III) chloride solution (12 g/w Fe) the oxidized maltose solution and then 554 g of sodium carbonate solution (17.3% g/w Fe) are added by stirring (wing stirrer) at room temperature.

Then adding baking soda to set the pH to 11, heating the solution to 50°C and keeping it at 50°C for 30 minutes, acidifying the solution to 5 to 6 by adding hydrochloric acid, keeping the solution at 50°C for another 70 minutes, and cooling the solution to room temperature, setting the pH to 6 to 7 by adding baking soda.

The solution is then filtered with a sterile filter and tested for sediment, then isolated by ethanol precipitation in a ratio of 1:0.85 and vacuum dried at 50°C.

171 g (86% by weight) of a brown amorphous powder with an iron content of 21,35% by weight (complexometrically determined) is obtained.

The molecular weight Mw 170 kDa

Comparison

The following comparison of the properties of iron-carbohydrate complexes of the invention with a commercial iron-sucrose complex shows that an increased iron content is possible, a heat treatment at higher temperatures is possible and the toxicity is reduced according to the invention (LD50). Other

	erfindungsgemäß	Eisenhydroxid/Saccharose-Komplex
Fe-Gehalt [%]	5,0	2,0
PH	5 - 7	10,5 - 11,0
80 - 350	34 - 54
Thermobehandlung	121°C/15'	100°C/35'
> 2000	> 200

Preferred embodiments of the invention 1. water-soluble iron-carbon complex, obtained from an aqueous iron (III) salt solution and an aqueous solution of the product of oxidation of one or more maltodextrins with an aqueous hypochlorite solution at pH in the alkaline range, whereby, when one maltodextrin is used, its dextrose equivalent is 5 to 20 and when a mixture of several maltodextrins is used, the dextrose equivalent of the mixture is 5 to 20 and the dextrose equivalent of the individual maltodextrins involved in the mixture is 2 to 40.2.when using a maltodextrin with a dextrose equivalent of 5 to 20 and when using a mixture of several maltodextrins, the dextrose equivalent of the mixture is 5 to 20 and the dextrose equivalent of the individual maltodextrins involved in the mixture is 2 to 40.3. Method 2 characterised by oxidation of the maltodextrin or maltodextrins in the presence of bromide ions.4. Method 2 or 3 characterised by use of iron as iron salt (III) chloride.5. Method 2, 3 or 4 characterised by oxidation of maltodextrin and iron (III) chloride to a low pH solution with a saline solution of such a kind as water.6. procedure in one of the forms 3 to 5, characterised by the implementation of 15 minutes to several hours at a temperature of 15°C to the boiling point.7. medicinal products containing the aqueous solution of an iron-carbon complex in the form 1 or 2 or in one of the forms 3 to 6.8. medicinal products in the form 7 characterised by the fact that it is formulated for parenteral or oral administration.9. use of the forms 1 to 6, or in the form 2 to 6.For the treatment or prophylaxis of iron deficiency.10. Use of iron-carbon complexes of formula 1 or obtained in accordance with formula 2 to 6 to manufacture a medicinal product for the treatment or prophylaxis of iron deficiency.11. Water-soluble iron-carbon complex of formula 1 for the treatment or prophylaxis of iron deficiency.

Claims (15)

1. Water soluble iron(III)-carbohydrate complexes on the basis of the oxidation products of maltodextrins, wherein the iron (III) carbohydrate complexes have a weight average molecular weight M_w of 80 kDa to 400 kDa.
2. Iron(III)-carbohydrate complexes according to claim 1, wherein the iron(III)-carbohydrate complexes have a weight average molecular weight M_w of 118 kDa to 400 kDa.
3. Iron(III)-carbohydrate complexes according to claims 1 or 2, characterized in that in the oxidation products of the maltodextrins 80 to 100 % of the aldehyde groups per molecule are oxidized.
4. Iron(III)-carbohydrate complexes according to any of claims 1 to 3, characterized in that in the oxidation of the maltodextrins the reducing power caused by the glucose content of the maltodextrin molecules is lowered to about 20% or less.
5. Iron(III)-carbohydrate complexes according to any of claims 1 to 4, characterized in that in the oxidation products of the maltodextrins the oxidation occured predominately at the terminal aldehyde group of the maltodextrin molecules.
6. Iron(III)-carbohydrate complexes according to any of claims 1 to 5, wherein the oxidation of the maltodextrins are obtained by the oxidation of maltodextrins with a hypochlorite solution in an aqueous solution.
7. Iron(III)-carbohydrate complexes according to any of claims 1 to 6, wherein the oxidation products of maltodextrins are obtained by oxidation of maltodextrins, where, when one maltodextrin is applied, its dextrose equivalent Iles between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture Iles between 2 and 40.
8. Iron(III)-carbohydrate complexes according to of claims 1 to 7 for use as a medicament for the treatment of iron deficiency anaemia.
9. Iron(III)-carbohydrate complexes according to any of claims 1 to 8 for use as a medicament for parenteral administration.
10. Iron(III)-carbohydrate complexes according to of claims 1 to 9 for use as a medicament for the parenteral administration in the form of a single dose of 500 to 1000 mg iron.
11. Aqueous solutions of the iron(III)-carbohydrate complexes according to any of claims 1 to 7.
12. Aqueous solutions of the iron(III)-carbohydrate complexes according to claim 1 for use as a medicament for the intravenous administration.
13. Aqueous solutions of the iron(III)-carbohydrate complexes according to claims 11 or 12, having an iron content of 1 % weight/vol, to 20% weight/vol.
14. Aqueous solutions of the Iron(III)-carbohydrate complexes according to of claims 11 to 13, which have been sterilized at at a temperature of 121 °C and above.
15. Aqueous solutions of the iron(ill)-carbohydrate complexes according to any of claims 11 to 14, which are devoid of preservatives.