IRON COMPOSITIONS AND METHODS OF MAKING AND USING THEM
Injectable iron compositions comprising iron, a carbohydrate, a stabilizing agent and water are provided. These iron compositions can be prepared by mixing iron with a carbohydrate and water to form a mixture and adding a stabilizing agent to the mixture to form the stable injectable iron composition. These compositions can be considered “ready-to-use” and can treat a variety of diseases, disorders, or conditions characterized by iron deficiency or dysfunctional iron metabolism, for example, anemia.
1 . An injectable iron composition comprising ferric carboxymaltose, a stabilizing agent comprising a carbohydrate comprising oxidized maltodextrin, a sodium compound and water.
2 . The injectable iron composition of claim 1 , wherein the ferric carboxymaltose is polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate.
3 . The injectable iron composition of claim 1 , wherein the oxidized maltodextrin is in the injectable iron composition in an amount of about 3 mg/mL to about 250 mg/mL of the injectable iron composition.
4 . The injectable iron composition of claim 1 , wherein the injectable iron composition has a total volume from about 50 mL to about 250 mL.
5 . The injectable iron composition of claim 1 , wherein the injectable iron composition provides from 2 mg to 10 mg of iron per 1 mL of the injectable iron composition.
6 . The injectable iron composition of claim 1 , wherein the ferric carboxymaltose is in a complex of 1.5 mg of carboxymaltose per 1 mg of iron.
7 . The injectable iron composition of claim 1 , wherein the sodium compound is sodium hydroxide, sodium chloride, sodium gluconate or a combination thereof.
8 . The injectable iron composition of claim 7 , wherein the sodium compound is sodium hydroxide and is in an amount from 0.08 mg/mL to 15 mg/mL and the injectable iron composition optionally further comprises L-histidine in an amount from 0 mg/mL to 1.5 mg/mL of the injectable iron composition.
9 . The injectable iron composition of claim 1 , wherein the injectable iron composition is used to treat iron deficiency anemia.
10 . The injectable iron composition of claim 1 , wherein the injectable iron composition is used to treat iron deficiency anemia in a human patient.
11 .- 120 . (canceled)
121 . An injectable iron composition comprising an iron-carbohydrate complex comprising ferric carboxymaltose, a stabilizing agent comprising an uncomplexed carbohydrate comprising carboxymaltose, a sodium compound and water.
122 . The injectable iron composition of claim 121 , wherein the ferric carboxymaltose is polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate.
123 . The injectable iron composition of claim 121 , wherein the uncomplexed carbohydrate comprising carboxymaltose is in the injectable iron composition in an amount of 3 mg/mL to about 250 mg/mL of the injectable iron composition.
124 . The injectable iron composition of claim 121 , wherein the injectable iron composition has a total volume from about 50 mL to about 250 mL.
125 . The injectable iron composition of claim 121 , wherein the injectable iron composition provides from 2 mg to 10 mg of iron per 1 mL of the injectable iron composition.
126 . The injectable iron composition of claim 121 , wherein the ferric carboxymaltose is in a complex of 1.5 mg of carboxymaltose per 1 mg of iron.
127 . The injectable iron composition of claim 121 , wherein the sodium compound is sodium hydroxide, sodium chloride, sodium gluconate or a combination thereof.
128 . The injectable iron composition of claim 127 , wherein the sodium compound is sodium hydroxide and is in an amount from 0.08 mg/mL to 15 mg/mL and the injectable iron composition optionally further comprises L-histidine in an amount from 0 mg/mL to 1.5 mg/mL of the injectable iron composition.
129 . The injectable iron composition of claim 121 , wherein the injectable iron composition is used to treat iron deficiency anemia.
130 . The injectable iron composition of claim 121 , wherein the injectable iron composition is used to treat iron deficiency anemia in a human patient.
131 . An injectable iron composition comprising an iron-carbohydrate complex comprising ferric carboxymaltose, a stabilizing agent comprising an uncomplexed carbohydrate comprising carboxymaltodextrin and a sodium compound.
132 . The injectable iron composition of claim 131 , wherein the ferric carboxymaltose is polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate.
133 . The injectable iron composition of claim 131 , wherein the uncomplexed carbohydrate comprising carboxymaltodextrin is in the injectable iron composition in an amount of 3 mg/mL to about 250 mg/mL of the injectable iron composition.
134 . The injectable iron composition of claim 131 , wherein the injectable iron composition has a total volume from about 50 mL to about 250 mL.
135 . The injectable iron composition of claim 131 , wherein the injectable iron composition provides from 2 mg to 10 mg of iron per 1 mL of the injectable iron composition.
136 . The injectable iron composition of claim 131 , wherein the ferric carboxymaltose is in a complex of 1.5 mg of carboxymaltose per 1 mg of iron.
137 . The injectable iron composition of claim 131 , wherein the sodium compound is sodium hydroxide, sodium chloride, sodium gluconate or a combination thereof.