# US 10,245,231 B2 · Dry acid concentrate in granulate form

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- Number: US 10,245,231 B2
- Document ID: US10245231B2
- Status: Granted
- Kind: B2
- Application number: 15/116,947
- Filed: 2015-02-05
- Published: 2017-01-12
- Granted: 2019-04-02
- Earliest claimed: 2014-02-07
- Assignees: Fresenius Medical Care Deutschland GmbH
- Applicants: Fresenius Medical Care Deutschland GmbH
- Inventors: Thierry Eyrard; Philippe Laffay; Benoit Luaire
- Web page: https://patentgrep.com/patent/US10245231B2

## CPC

- A61M 1/1656: {Apparatus for preparing dialysates}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61K 9/1682: {Processes}
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61M 1/1666: {by dissolving solids}
- A61M 1/1668: {Details of containers}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## 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.

## Claims

### Claim 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 MgCl2, CaCl2 and KCl.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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.

### Claim 5 (depends on 2)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 9)

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.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 1)

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.

### Claim 18 (depends on 17)

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

### Claim 19 (depends on 1)

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