Dry acid concentrate in granulate form

Patent metadata

Field	Value
Publication number	US-10245231-B2
Application number	US-201515116947-A
Country	US
Kind code	B2
Filing date	Feb 5, 2015
Priority date	Feb 7, 2014
Publication date	Apr 2, 2019
Grant date	Apr 2, 2019

Abstract

The present invention relates to a novel dry acid concentrate (DAC) for a dialysis liquid and to a dialysis liquid, which is made from said concentrate, and which may be used for purifying blood. The invention further relates to a method of making the dry acid concentrate as well as the dialysis liquid. It also relates to a container (10) comprising said acid concentrate, and which is—in certain embodiments—specially adapted to a dialysis unit.

First claim

The invention claimed is:

1. A dry concentrate suitable to form a liquid acid concentrate or a part of a liquid acid concentrate usable in dialysis comprising
a first component comprising a first granulate comprising a plurality of first granules comprising sodium chloride and glucose, wherein the first granules are aggregates comprising sodium chloride and glucose and
a second component comprising a second granulate comprising a plurality of second granules, wherein said second granules comprise at least one further physiologically acceptable electrolyte, which is different from sodium chloride,
or a second component in the form of a powder, wherein said powder comprises at least one further physiologically acceptable electrolyte which is different from sodium chloride, and
wherein said powder comprises a plurality of fine particles, wherein each particle comprises or consists of one of said at least one further physiologically acceptable electrolyte,
or a mixture of said second granulate and said powder;
wherein said concentrate is substantially free of a base component that is suitably used in dialysis, and the second component comprises MgCl 2 , CaCl 2 and KCl.

2. The dry concentrate according to claim 1 , wherein the first and the second components comprise or consist of said first and second granulates.

3. The dry concentrate according to claim 2 , wherein the first granules of the first component exhibit a higher average equivalent diameter than the second granules of the second component.

4. The dry concentrate according to claim 2 , wherein the second granulate comprises at least 50 wt-% of second granules, respectively based on the total weight of the first granulate in the dry concentrate, which have an equivalent diameter of above 1 to below 5 mm.

5. The dry concentrate according to claim 2 , wherein the second granulate comprises at least 90 wt-% of second granules, respectively based on the total weight of the first granulate in the dry concentrate, which have an equivalent diameter of above 1 to below 5 mm.

6. The dry concentrate according to claim 1 , wherein the first granulate comprises at least 50 wt-% of first granules, respectively based on the total weight of the first granulate in the dry concentrate, which have an equivalent diameter of above 0.5 to below 12.5 mm.

7. The dry concentrate according to claim 1 , wherein said second component comprises a cation selected from the cations of magnesium, calcium, potassium, or mixtures of two or more thereof; and comprises an anion selected from chloride, acetate, lactate, or mixtures of two or more thereof.

8. The dry concentrate according to claim 1 , further comprising citric acid as a third component.

9. The dry concentrate according to claim 1 , wherein the granulates of the first component or the first and the second components are obtainable via a manufacturing process comprising the following:
dry compressing said NaCl and glucose to obtain first compacts, or dry compressing said NaCl and glucose and the at least one further physiologically acceptable electrolyte to obtain first and second compacts, wherein said dry compressing of said first and said dry compressing of said second compacts are conducted separately from each other;
reducing the size of said first compacts to form the first granulate comprising the plurality of first granules,
or reducing the size of said first and second compacts to form the first and second granulates comprising a plurality of first and second granules.

10. The dry concentrate according to claim 9 ,
wherein the dry compressing comprises passing the NaCl and glucose or the NaCl and glucose, and the at least one further physiologically acceptable electrolyte under pressure between two rolls with parallel axes, which are driven in mutually counter-rotating rotation sense;
wherein reducing the size of said first and second compacts is achieved by grinding, milling, crushing, or a combination of two or more thereof; and
wherein said dry compressing and reduction of size are carried out continuously.

11. The dry concentrate according to claim 1 , wherein said concentrate is substantially free of sodium bicarbonate.

12. The dry concentrate according to claim 1 , wherein the first granulate comprises at least 90 wt-% of first granules, respectively based on the total weight of the first granulate in the dry concentrate, which have an equivalent diameter of above 0.5 to below 12.5 mm.

13. A process for the preparation of the dry concentrate according to claim 1 comprising the following:
dry compressing said NaCl and glucose to obtain first compacts, or dry compressing said NaCl and glucose, and the at least one further physiologically acceptable electrolyte to obtain first and second compacts, wherein said dry compressing of said first and said dry compressing of said second compacts are conducted separately from each other;
reducing the size of said first compacts to form the first granulate comprising the plurality of first granules,
or reducing the size of said first and second compacts to form the first and second granulates comprising a plurality of first and second granules.

14. The process according to claim 13 , wherein said manufacturing process further comprises sieving of said granulates obtained by reducing the size of said compacts through at least two sieves.

15. A container comprising at least the dry concentrate according to claim 1 .

16. A dialysis or preparation unit, wherein the preparation unit serves to prepare a liquid concentrate to be used for the preparation of a dialysis solution, comprising at least one according to claim 1 ; or a container comprising at least the dry concentrate, wherein the container is connected to the dialysis or preparation unit.

17. A method of preparing a liquid acid concentrate which in turn serves the preparation of a dialysis solution, at least comprising (i):
(i) mixing the concentrate according to claim 1 with water.

18. A method of claim 17 , wherein (i) is carried out in the presence of a gas.

19. A liquid acid concentrate formed from the dry concentrate according to claim 1 .

Assignees

• Fresenius Medical Care Deutschland Gmbh

Inventors

• Eyrard Thierry
• Laffay Philippe
• Luaire Benoit

Classifications

• A61K31/194

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

• A61K9/1682

  Processes · CPC title

• A61K31/7004

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

• A61M1/1668

  Details of containers · CPC title

• A61M1/1666

  by dissolving solids · CPC title