Concentrate for medical solutions, production thereof and use thereof in dialysis

• US 9,249,345 B2
• Filed: 08/17/2011
• Issued: 02/02/2016
• Est. Priority Date: 08/18/2010
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Deutschland GmbH (Fresenius SE & Co. KGaA)
• Inventors: Schweitzer, Thomas, Fichert, Thomas, Mathis, Pascal
• Primary Examiner(s): Buie-Hatcher, Nicole M
• Assistant Examiner(s): ASDJODI, MOHAMMADREZA
• Application Number:
  US13/814,900
• Publication Number:
  US 20130134357A1
• Time in Patent Office: 1,630 Days
• Field of Search: 252/364
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: C09K 3/00 Materials not provided for elsewhere

Abstract

The present invention relates to a novel dry concentrate for producing medical solutions, more particularly dialysis solutions, which comprises electrolyte components, buffer components and an osmotic agent, wherein the concentrate comprises magnesium carbonate instead of magnesium chloride. The use of magnesium carbonate as an electrolyte prevents the formation of slurries. By providing anhydrous glucose as an osmotic agent, and by optionally spatially separating this osmotic agent from other components, the occurrence of caking of the concentrate is additionally avoided. The occurrence of caking is further reduced by providing the buffer component sodium bicarbonate together with sodium chloride separate from all other components. The concentrate of the present invention is particularly suitable for use in multi-chamber container bag systems. The concentrate of the present invention exhibits good dissolution behavior and improved storage stability.

Claims

1. A concentrate for producing a medical solution, wherein the concentrate comprises at least three spatially separated parts, wherein the first part comprises magnesium carbonate, anhydrous calcium chloride, and a physiologically acceptable acid selected from the group consisting of citric acid, malic acid, fumaric acid, isocitric acid, succinic acid and oxalic acid, and is suitable for use as the medical solution upon addition of an aqueous medium.

2. The concentrate according to claim 1, wherein the concentrate further comprises at least one electrolyte component, at least one osmotic component and at least one buffer component.

3. The concentrate according to claim 1, wherein the magnesium carbonate is 4MgCO₃×

Mg(OH)₂×

5H₂O.

4. The concentrate according to claim 2, wherein the at least one electrolyte component comprises potassium chloride.

5. The concentrate according to claim 2, wherein the at least one osmotic component comprises glucose.

6. The concentrate according to claim 5, wherein glucose is provided as a separate part of the concentrate.

7. The concentrate according to claim 2, wherein the at least one buffer component comprises sodium bicarbonate.

8. The concentrate according to claim 7, wherein sodium bicarbonate is provided as a separate part of the concentrate.

9. The concentrate according to claim 1, wherein the second part comprises glucose.

10. The concentrate according to claim 9, wherein the third part comprises sodium bicarbonate.

11. The concentrate according to claim 5, wherein the glucose is anhydrous glucose.

12. The concentrate according to claim 8, wherein sodium chloride together with the sodium bicarbonate is present as a separate part of the concentrate.

13. The concentrate according to claim 1, wherein the physiologically acceptable acid is citric acid.

14. The concentrate according to claim 1, wherein the concentrate is present in dry form.

15. The concentrate according to claim 1, wherein the concentrate is substantially free of magnesium chloride.

16. A concentrate for producing a medical solution, wherein the concentrate comprises at least three spatially separated parts, wherein the first part comprises magnesium carbonate and/or anhydrous calcium chloride, the second part comprises glucose and the third part comprises sodium bicarbonate, and wherein the concentrate is suitable for use as the medical solution upon addition of an aqueous medium.

17. The concentrate according to claim 16, wherein the concentrate further comprises at least one electrolyte component.

18. The concentrate according to claim 16, wherein the magnesium carbonate is 4MgCO₃×

Mg(OH)₂×

5H₂O.

19. The concentrate according to claim 16, wherein the concentrate comprises anhydrous calcium chloride.

20. The concentrate according to claim 19, further comprising a physiologically acceptable acid selected from the group consisting of citric acid, malic acid, fumaric acid, isocitric acid, succinic acid and oxalic acid.

21. The concentrate according to claim 17, wherein the at least one electrolyte component comprises potassium chloride.

22. The concentrate according to claim 16, wherein the glucose is anhydrous glucose.

23. The concentrate according to claim 16, wherein the third part further comprises sodium chloride.

24. The concentrate according to claim 20, wherein the physiologically acceptable acid is citric acid.

25. The concentrate according to claim 16, wherein the concentrate is present in dry form.

26. The concentrate according to claim 16, wherein the concentrate is substantially free of magnesium chloride.