Dialysis solution for peritoneal dialysis

• US 6,284,140 B1
• Filed: 03/11/1997
• Issued: 09/04/2001
• Est. Priority Date: 12/18/1992
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Sommermeyer, Klaus, Passlick-Deetjen, Jutta
• Primary Examiner(s): KIM, SUN U
• Application Number:
  US08/815,442
• Time in Patent Office: 1,638 Days
• Field of Search: 210/645, 210/646, 210/647, 210/542, 424/677, 424/678, 424/679, 424/680, 424/681, 424/722, 424/717, 435/2, 436/826, 514/60, 514/832, 514/929, 604/29, 252/1, 252/183.13, 252/183.16, 536/1.11, 536/111
• US Class Current: 210/647
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61M 1/287 Dialysates therefor

Abstract

The present invention relates to dialysis solutions for peritoneal dialysis, containing hydroxyethyl starch as the osmotically-active substance, electrolytes and, optionally, conventional additives, where the hydroxyethyl starch has a molecular weight Mw in the range from 10,000 to 150,000, a substitution MS in the range from 0.10 to 0.40, a substitution DS in the range from 0.09 to 0.35 and a substitution ratio C2/C6≧8. With this peritoneal dialysis solution it is possible, with an outstanding ultrafiltration, to maintain a longer dwell time, for example the dialysis solution can be utilized for a period of 12 hours in the CAPD without replacement. In addition, the inventive dialysis solution is also particularly advantageous for patients with residual kidney function. The resorption of the osmotically active substance is clearly diminished and even after a dwell time of 12 hours it amounts to a maximum of 60-70%.

Claims

1. A method for peritoneal dialysis comprising treating a subject with a peritoneal dialysis solution comprising at least one member selected from the group consisting of electrolytes and additives, and hydroxyethyl starch, wherein said hydroxyethyl starch comprises an average molecular weight in a range from 10,000 to 150,000, a molar substitution in a range from 0.10 to 0.40, a degree of substitution in a range from 0.09 to 0.35, and a substitution ratio C2/C6 in a range from 8 to 25, and wherein said hydroxyethyl starch is present in said peritoneal dialysis solution in an effective amount for peritoneal dialysis.

2. The method according to claim 1, wherein said hydroxyethyl starch comprises an average molecular weight in the range from 10,000 to 55,000.

3. The method according to claim 2, wherein said hydroxyethyl starch comprises an average molecular weight in the range from 20,000 to 29,000.

4. The method according to claim 1, wherein said molar substitution of said hydroxyethyl starch comprises a value in the range from 0.10 to 0.24.

5. The method according to claim 4, wherein said molar substitution of said hydroxyethyl starch comprises a value in the range from 0.20 to 0.24.

6. The method according to claim 1, wherein said degree of substitution of said hydroxyethyl starch comprises a value in the range from 0.09 to 0.23.

7. The method according to claim 1, wherein said effective amount of said hydroxyethyl starch is a concentration in a range from 3 to 10 percent by weight, based on said peritoneal dialysis solution.

8. The method according to claim 1, wherein said peritoneal dialysis solution comprises an effective amount within a range from 3 to 10 percent by weight of hydroxyethyl starch, 125 to 150 mMol/liter of sodium ions, 90 to 115 mMol/liter of chloride ions, 0.3 to 1.5 mMol/liter of magnesium ions, 1.0 to 2.5 mMol/liter of calcium ions and 30 to 45 mMol/liter of salts selected from the group consisting of lactate, acetate, and bicarbonate.

9. The method according to claim 8, wherein said peritoneal dialysis solution further comprises from 0.1 to 4.25 percent by weight of glucose, based on said peritoneal dialysis solution.

10. The method according to claim 1, wherein said electrolytes are selected from the group consisting of chlorides, lactates, acetates, and bicarbonates.

11. The method according to claim 1, wherein said additives are selected from the group consisting of pharmacologically active substances suitable for dialysis solutions.

12. The method according to claim 11, wherein said pharmacologically active substances are selected from the group consisting of vasodilators, diuretics, hormones, and vitamins.

14. The dialysis solution according to claim 11, wherein said hydroxyethyl starch comprises an average molecular weight in the range from about 20,000 to 29,000.

15. The dialysis solution according to claim 14, wherein said molar substitution of the said hydroxyethyl starch comprises a value in the range from 0.10 to 0.24.

16. The dialysis solution according to claim 15, wherein said molar substitution of said hydroxyethyl starch comprises a value in the range from 0.20 to 0.24.

17. The dialysis solution according to claim 16, wherein said degree of substitution of said hydroxyethyl starch comprises a value in the range from 0.09 to 0.23.

18. The dialysis solution according to claim 16, wherein said hydroxyethyl starch is present in a concentration in the range from 3 to 10 percent.

19. The dialysis solution according to claim 18, wherein said dialysis solution comprises from 3 to 10 percent by weight of hydroxyethyl starch, 125 to 150 mMol/liter of sodium ions, 90 to 115 mMol/litre of chloride ions, 0.3 to 1.5 mMol/liter of magnesium ions, 1.0 to 2.5 mMol liter of calcium ions, and 30 to 45 mMol/liter of a salt selected from the group consisting of lactate, acetate, and bicarbonate.

20. The dialysis solution according to claim 19, wherein said dialysis solution, further comprises from 0.1 to 4.25 percent by weight of glucose, based on said peritoneal dialysis solution.

13. A dialysis solution for peritoneal dialysis comprising hydroxyethyl starch, and at least one member selected from the group consisting of electrolytes and additives, wherein said hydroxyethyl starch comprises an average molecular weight in a range from 10,000 to 55,000, a molar substitution in a range from 0.10 to 0.40, a degree of substitution in a range from 0.09 to 0.35 and a substitution ratio C2/C6 in a range from 8 to 25.

21. The dialysis solution according to claim 13, wherein said electrolytes are selected from the group consisting of chlorides, lactates, acetates, and bicarbonates.

22. The dialysis solution according to claim 13, wherein said additives are selected from the group consisting of pharmacologically active substances suitable for dialysis solutions.

23. The dialysis solution according to claim 13, wherein said pharmacologically active substances are selected from the group consisting of vasodilators, diuretics, hormones, and vitamins.