Dialysis solution having at least one osmotic agent

Patent metadata

Field	Value
Publication number	US-11090388-B2
Application number	US-201615775956-A
Country	US
Kind code	B2
Filing date	Nov 14, 2016
Priority date	Nov 13, 2015
Publication date	Aug 17, 2021
Grant date	Aug 17, 2021

Abstract

The invention relates to a dialysis solution having at least one osmotic agent, with the osmotic agent being a polysaccharide modified by 2-sulfoethyl groups.

First claim

The invention claimed is:

1. A dialysis solution having at least one osmotic agent, characterized in that the osmotic agent is a modified polysaccharide, wherein the modified polysaccharide is a 2-sulfoethyl starch, characterized in that the starch underlying the 2-sulfoethyl starch is a starch that was reduced with NaBH 4 before the sulfoethylation, and wherein the molar mass of the unmodified sulfoethyl starch is between 1,000 and 20,000 g/mol.

2. A dialysis solution in accordance with claim 1 , characterized in that the modified polysaccharide has a degree of substitution between 0.05 and 1.0.

3. A dialysis solution in accordance with claim 1 , characterized in that the dialysis solution does not contain any further osmotic agent in addition to the modified polysaccharide.

4. A dialysis solution in accordance with claim 1 , characterized in that the dialysis solution furthermore has electrolytes and a buffer system.

5. A dialysis solution in accordance with claim 4 , characterized in that the electrolytes are selected from the group consisting of sodium ions, potassium ions, calcium ions, magnesium ions, chloride ions, and combinations thereof.

6. A dialysis solution in accordance with claim 4 , characterized in that the buffer system is a lactate buffer, a hydrogen carbonate buffer, or a combination thereof.

7. A dialysis solution in accordance with claim 4 , characterized in that the electrolytes, where present and independently of one another, are present in the following concentrations in the dialysis solution (figures in mmol/l):

Sodium ions
125-150

Potassium ions
  0-4.5

Calcium ions
  0-2.5

Magnesium ions
0-5

Chloride ions
 90-120

Lactate/Lactic acid/(Hydrogen) carbonate/CO 2
30-60.

8. A dialysis solution in accordance with claim 1 , characterized in that the pH of the dialysis solution is between 5.0 and 8.0.

9. A dialysis solution in accordance with claim 1 for use in peritoneal dialysis.

10. A dialysis solution in accordance with claim 1 , characterized in that the modified polysaccharide has a degree of substitution between 0.2 and 0.5.

11. A dialysis solution in accordance with claim 1 , characterized in that the dialysis solution comprises mixtures of the modified polysaccharide and further osmotic agents.

12. A dialysis solution in accordance with claim 1 , characterized in that the dialysis solution comprises mixtures of the modified polysaccharide and (i) carnitine or (ii) taurine.

13. A dialysis solution in accordance with claim 1 , characterized in that the pH of the dialysis solution is between 5.5 and 6.5.

14. A dialysis solution in accordance with claim 1 , characterized in that the pH of the dialysis solution is between 6.5 and 7.5.

15. A method of preparing an osmotic agent of a dialysis solution in accordance with claim 1 comprising modification of a polysaccharide starch by 2-sulfoethyl groups.

Assignees

• Fresenius Medical Care Deutschland Gmbh
• Univ Jena Friedrich Schiller

Inventors

• Heinze Thomas
• Hampe Robert
• Berlich Robert
• Finkler Lisa
• Burkhart Jens Lothar

Classifications

• A61K47/36 Primary

  Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin · CPC title

• A61K31/205

  Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine · CPC title

• A61K31/718

  Starch or degraded starch, e.g. amylose, amylopectin · CPC title

• A61K36/47

  Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean) · CPC title

• A61K31/185

  Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids (hydroxamic acids A61K31/16; peroxy acids A61K31/327) · CPC title