Dialysis precursor composition

Patent metadata

Field	Value
Publication number	US-9821102-B2
Application number	US-201214128130-A
Country	US
Kind code	B2
Filing date	Jun 11, 2012
Priority date	Jun 20, 2011
Publication date	Nov 21, 2017
Grant date	Nov 21, 2017

Abstract

The present invention concerns a dialysis acid precursor composition for use during preparation of a dialysis acid concentrate solution and for mixing with water, a sodium containing concentrate, and a bicarbonate containing concentrate into a ready-for-use dialysis solution. Said dialysis acid precursor composition consists of powder components comprising glucose, at least one dry acid and at least one calcium salt, and optionally potassium salt, and magnesium salt. According to the invention said glucose and said at least one calcium salt, are present as anhydrous components in said dialysis acid precursor composition.

First claim

The invention claimed is:

1. A dialysis acid precursor composition for use during preparation of a dialysis acid concentrate solution and for mixing with water, a sodium containing concentrate, and a bicarbonate containing concentrate into a ready-for-use dialysis solution, the dialysis acid precursor composition consisting of:
powder components comprising a glucose powder, at least one dry acid powder, a calcium chloride powder, and a hydrated magnesium chloride powder selected from the group consisting of a magnesium chloride hexahydrate powder and a magnesium chloride dihydrate powder, wherein the glucose powder and the calcium chloride powder are present as anhydrous components in the dialysis acid precursor composition, wherein the calcium chloride is in a quantity such that a concentration of 30-500 mM calcium ions is provided in the dialysis acid concentrate solution, and wherein the dialysis acid precursor composition is sealed in a moisture-resistant container with a water vapour transmission rate less than 0.3 g/m2/d at 38° C./90% RH.

2. A dialysis precursor composition according to claim 1 , wherein said at least one dry acid is selected from the group comprising lactic acid, citric acid, gluconic acid, glucono-δ-lactone, N-acetyl cystein and α-lipoic acid.

3. A dialysis precursor composition according to claim 1 , wherein said moisture-resistant container has a water vapour transmission rate of less than 0.2 g/m2/d at 38° C./90% RH.

4. A dialysis precursor composition according to claim 1 , wherein said moisture-resistant container has a water vapour transmission rate of more than 0.05 g/m2/d at 38° C./90% RH.

5. A dialysis precursor composition according to claim 1 , wherein said dialysis precursor composition is configured to be mixed with a prescribed volume of water within said moisture-resistant container to provide a dialysis acid concentrate solution.

6. The dialysis acid precursor composition of claim 1 wherein the powder components further comprise a potassium salt.

7. The dialysis precursor acid composition according to claim 1 , wherein the powder components consist of the glucose powder, the at least one dry acid powder, the calcium chloride powder, the hydrated magnesium chloride powder, and a potassium salt, wherein the glucose powder and the calcium chloride powder are present as anhydrous components.

8. A method of providing a dialysis acid concentrate solution for dilution with water, a sodium containing concentrate, and a bicarbonate containing concentrate to produce a ready-for-use dialysis solution, the method comprising:
(a) providing a dialysis precursor composition comprising a glucose powder, at least one dry acid powder, a calcium chloride powder, and a hydrated magnesium chloride powder selected from the group consisting of a magnesium chloride hexahydrate powder and a magnesium chloride dihydrate powder, wherein the glucose powder and the calcium chloride powder are present as anhydrous components in the dialysis acid precursor composition,
(b) providing the dialysis precursor composition in a sealed, moisture-resistant container with a water vapour transmission rate less than 0.3 g/m2/d at 38° C./90% RH, and
(c) adding a prescribed volume of water to the dialysis precursor composition in the container and mixing thereof, thereby providing the dialysis acid concentrate solution, wherein the calcium chloride is in a quantity such that a concentration of 30-500 mM calcium ions is provided in the dialysis acid concentrate solution.

9. The method of claim 8 further comprising using the dialysis acid precursor composition to prepare at least one of a dialysis solution, an infusion solution, a replacement solution, a rinsing solution and a priming solution.

10. The method of claim 8 wherein the dialysis precursor composition includes a potassium salt.

11. The method of claim 8 , wherein the dialysis precursor composition consist of the glucose powder, the at least one dry acid powder, the calcium chloride powder, the hydrated magnesium chloride powder, and a potassium salt, wherein the glucose powder and the calcium chloride powder are present as anhydrous components.

12. A method using a dialysis acid concentrate solution, the method comprising:
providing a dialysis precursor composition comprising an anhydrous glucose powder, a dry acid powder, an anhydrous calcium chloride powder, and a hydrated magnesium chloride powder selected from the group consisting of a magnesium chloride hexahydrate powder and a magnesium chloride dihydrate powder;
sealing the dialysis precursor in a moisture-resistant container having a water vapor transmission rate less than 0.3 g/m2/d at 38° C./90% RH; and
adding a prescribed amount of water to the dialysis precursor composition in the container to form a dialysis acid concentrate solution, wherein the calcium chloride is in a quantity such that a concentration of 30-500 mM calcium ions is provided in the dialysis acid concentrate solution.

13. The method of claim 12 comprising diluting the dialysis acid concentrate solution with at least one of a sodium containing concentrate and a bicarbonate containing concentrate to produce a ready-for-use dialysis solution.

14. The method of claim 12 , wherein the dialysis precursor composition consist of the anhydrous glucose powder, the dry acid powder, the anhydrous calcium chloride powder, the hydrated magnesium chloride powder, and a potassium salt.

Assignees

• Jansson Olof
• Linden Torbjorn
• Wieslander Anders
• Gambro Lundia Ab

Inventors

• Jansson Olof
• Linden Torbjorn
• Wieslander Anders

Classifications

• A61K31/194

  having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid · CPC title

• A61K33/06

  Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} · CPC title

• A61K31/191

  having two or more hydroxy groups, e.g. gluconic acid · CPC title

• A61K31/19 Primary

  Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) · CPC title

• A61M1/1654 Primary

  Dialysates therefor · CPC title