Vitamin-containing nutrition infusion for administration through peripheral vein

Patent metadata

Field	Value
Publication number	US-9861575-B2
Application number	US-201213668558-A
Country	US
Kind code	B2
Filing date	Nov 5, 2012
Priority date	May 7, 2010
Publication date	Jan 9, 2018
Grant date	Jan 9, 2018

Abstract

A nutrition infusion is provided for administration through a peripheral vein that contains a vitamin B group and vitamin C stably and includes two solutions of a sugar solution and an amino acid solution. In the nutrition infusion for administration through a peripheral vein, the sugar solution contains vitamin B1, vitamin B12, and pantothenic acid and has a pH of 4.7 to 5.5, and the amino acid solution contains vitamin B2, folic acid, vitamin C, and biotin and has a pH of 7.0 to 7.5.

First claim

The invention claimed is:

1. A method of administering a nutrition infusion, comprising:
providing a kit comprising a first package containing a sugar solution comprising a reducing sugar, vitamin B1, vitamin B12, and pantothenic acid and having a pH of 4.7 to 5.5, and a second package separated from the first package and containing an amino acid solution comprising an amino acid, vitamin B2, folic acid, vitamin C, biotin, and sulfite in an amount of 25 mg/L to 100 mg/L, and having a pH of 7.0 to 7.5, wherein the sugar solution and the amino acid solution are prepared such that a nutrition infusion produced by mixing only the sugar solution and the amino acid solution contains 100 μg/L to 400 μg/L of the folic acid;
producing the nutrition infusion from the kit by mixing the sugar solution and the amino acid solution; and
administering the nutrition infusion through a peripheral vein of a subject.

2. The method according to claim 1 , wherein the reducing sugar in the sugar solution is glucose, and the sugar solution and the amino acid solution are prepared such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution has a glucose concentration of 4 w/v % to 10 w/v %.

3. The method according to claim 1 , wherein the sugar solution further comprises vitamin B6, and the amino acid solution further comprises a nicotinic acid derivative.

4. The method according to claim 1 , wherein the sugar solution further comprises acetic acid as a pH adjustor.

5. The method according to claim 1 , wherein the sugar solution and the amino acid solution are prepared such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution has a pH of 6.5 to 7.4.

6. The method according to claim 1 , wherein the sugar solution and the amino acid solution are prepared such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution further contains:
Vitamin B1 in an amount of 1 mg/L to 10 mg/L,
Vitamin B2 in an amount of 1 mg/L to 4 mg/L converted in terms of riboflavin,
Vitamin B6 in an amount of 1 mg/L to 5 mg/L,
Vitamin B12 in an amount of 1 μ/L to 10 μg/L,
Pantothenic acids in an amount of 4 mg/L to 16 mg/L,
Nicotinic acid derivative in an amount of 10 mg/L to 40 mg/L,
Biotin in an amount of 25 μg/L to 100 μg/L, and
Vitamin C in an amount of 50 mg/L to 200 mg/L.

7. The method according to claim 1 , wherein
the sugar solution further comprises sodium chloride in an amount of 0.5 g/L to 2 g/L, a calcium chloride hydrate in an amount of 0.2 g/L to 1 g/L, sodium lactate in an amount of 2 g/L to 15 g/L, a magnesium sulfate hydrate in an amount of 0.5 g/L to 2 g/L, and a zinc sulfate hydrate in an amount of 1 mg/L to 4 mg/L,
the amino acid solution comprises the amino acid in an amount of 50 g/L to 300 g/L in terms of a free amino acid, and
the volume ratio between the sugar solution and the amino acid solution is 2:1 to 3:1.

8. The method according to claim 1 , wherein the sugar solution and the amino acid solution are prepared such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution contains L-tryptophan in an amount of 0.04 g/L to 3.0 g/L, N-acetyl-L-cysteine in an amount of 0.01 g/L to 2.0 g/L, or both.

9. The method according to claim 1 , wherein the sugar solution has a pH of 4.9 to 5.5.

10. The method according to claim 1 , wherein the volume ratio of the sugar solution to the amino acid solution is 2:1 to 3:1.

11. The method according to claim 1 , wherein the amino acid solution has a pH of 7.0 to 7.2.

12. The method according to claim 1 , wherein the amino acid solution has a pH of 7.1 to 7.5.

13. The method according to claim 1 , wherein the amino acid solution has a pH of 7.1 to 7.2.

14. The method according to claim 1 , wherein the sugar solution and the amino acid solution are prepared such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution further contains:
L-Isoleucine in an amount of 0.2 g/L to 14.0 g/L,
L-Leucine in an amount of 0.4 g/L to 20.0 g/L,
L-Lysine in an amount of 0.2 g/L to 14.0 g/L,
L-Methionine in an amount of 0.1 g/L to 8.0 g/L,
L-Phenyl alanine in an amount of 0.2 g/L to 12.0 g/L,
L-Threonine in an amount of 0.1 g/L to 8.0 g/L,
L-Tryptophan in an amount of 0.04 g/L to 3.0 g/L,
L-Valine in an amount of 0.1 g/L to 16.0 g/L,
L-Alanine in an amount of 0.2 g/L to 14.0 g/L,
L-Arginine in an amount of 0.2 g/L to 14.0 g/L,
L-Aspartic acid in an amount of 0.01 g/L to 4.0 g/L,
L-Glutamic acid in an amount of 0.01 g/L to 6.0 g/L,
L-Histidine in an amount of 0.1 g/L to 8.0 g/L,
L-Proline in an amount of 0.1 g/L to 10.0 g/L,
L-Serine in an amount of 0.1 g/L to 6.0 g/L,
L-Tyrosine in an amount of 0.01 g/L to 2.0 g/L,
Glycine in an amount of 0.1 g/L to 12.0 g/L, and
L-Cysteine in an amount of 0.01 g/L to 2.0 g/L.

15. The method according to claim 1 , wherein the first package and the second package are formed in a container made of at least one material selected from the group consisting of polyethylene, polypropylene, and cyclic polyolefin.

16. The method according to claim 1 , wherein the amino acid solution further comprises citric acid as a pH adjustor.

17. The method according to claim 1 , wherein the amino acid solution further comprises citric acid such that the nutrition infusion produced by mixing only the sugar solution and the amino acid solution further contains 5 mEq/L to 15 mEq/L of the citric acid.

18. A method of administering a nutrition infusion, comprising:
administering, through a peripheral vein of a subject, a nutrition infusion prepared by mixing a sugar solution comprising a reducing sugar, vitamin B1, vitamin B12, and a pantothenic acid and having a pH of 4.7 to 5.5, and an amino acid solution comprising an amino acid, vitamin B2, folic acid, vitamin C, biotin, and sulfite in an amount of 25 mg/L to 100 mg/L, and having a pH of 7.0 to 7.5,
wherein the nutrition infusion comprises 100 μg/L to 400 μg/L of the folic acid, and the nutrition infusion has a pH of 6.5 to 7.4.

19. The method according to claim 18 , wherein the reducing sugar in the sugar solution is glucose, and the nutrition infusion has a glucose concentration of 4 w/v % to 10 w/v %.

20. The method according to claim 18 , wherein the sugar solution further comprises vitamin B6, and the amino acid solution further comprises a nicotinic acid derivative.

21. The method according to claim 18 , wherein the sugar solution further comprises acetic acid as a pH adjustor.

22. The method according to claim 18 , wherein the nutrition infusion has a pH of 6.8 to 7.4.

23. The method according to claim 18 , wherein the nutrition infusion contains:
Vitamin B1 in an amount of 1 mg/L to 10 mg/L,
Vitamin B2 in an amount of 1 mg/L to 4 mg/L converted in terms of riboflavin,
Vitamin B6 in an amount of 1 mg/L to 5 mg/L,
Vitamin B12 in an amount of 1 μg/L to 10 μg/L,
Pantothenic acids in an amount of 4 mg/L to 16 mg/L,
Nicotinic acid derivative in an amount of 10 mg/L to 40 mg/L,
Biotin in an amount of 25 μg/L to 100 μg/L, and
Vitamin C in an amount of 50 mg/L to 200 mg/L.

24. The method according to claim 18 , wherein the sugar solution further comprises sodium chloride in an amount of 0.5 g/L to 2 g/L, a calcium chloride hydrate in an amount of 0.2 g/L to 1 g/L, sodium lactate in an amount of 2 g/L to 15 g/L, a ma

Assignees

• Ajinomoto Kk
• Ea Pharma Co Ltd

Inventors

• Abiko Kazuhiro
• Katsura Toshiyuki

Classifications

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P7/08

  Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04) · CPC title

• A61K31/51

  Thiamines, e.g. vitamin B1 · CPC title

• A61K31/7004 Primary

  Monosaccharides having only carbon, hydrogen and oxygen atoms · CPC title

• A61K31/525

  Isoalloxazines, e.g. riboflavins, vitamin B2 · CPC title