Dialysis solutions with reduced levels of glucose degradation products

• US 7,053,059 B2
• Filed: 07/25/2003
• Issued: 05/30/2006
• Est. Priority Date: 07/25/2003
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Martis, Leo, Zieske, Paul, Choo, Carolyn
• Primary Examiner(s): Peselev, Elli
• Application Number:
  US10/628,065
• Publication Number:
  US 20050020507A1
• Time in Patent Office: 1,040 Days
• Field of Search: 514/23
• US Class Current: 514/23
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2027 having frangible parts
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• 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: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• 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

Abstract

Dialysis solutions with enhanced biocompatibility are provided. The dialysis solutions include a first acidic solution and a second acidic solution that are admixed to form a ready-to-use dialysis solution with reduced levels of glucose degradation products prior to use. The first acidic solution includes a dextrose concentrate, and the second acidic solution includes a buffer concentrate, such as a lactate-based buffer. The first and second acid solutions are separately sterilized prior to mixing to form the ready-to-use dialysis solutions. The dialysis solutions can be used in a variety of different applications, such as infusion into a patient during peritoneal dialysis.

Claims

1. A dialysis solution comprising:

a first acidic solution including a dextrose concentrate and having a pH ranging from about 2.8 to about 3.8; and

a second acidic solution including a buffer concentrate wherein the first acidic solution and the second acidic solution are admixed to form a ready-to-use dialysis solution, and wherein the second acidic solution has pH of less than 5.5.

2. The dialysis solution of claim 1 wherein the dextrose concentrate includes, dextrose, calcium chloride, and magnesium chloride.

3. The dialysis solution of claim 1 wherein the buffer concentrate includes a lactate-based Concentrate.

4. The dialysis solution of claim 1 wherein the ready-to-use dialysis solution includes about 1.5% to about 4.25% of dextrose.

5. The dialysis solution of claim 1 wherein the ready-to-use dialysis solution includes sodium and about 2.5 mEq/L to about 3.5 mEq/L of calcium.

6. The dialysis solution of claim 1 wherein the ready-to-use dialysis solution includes about 40 mEq/L of lactate.

7. A two part peritoneal dialysis solution comprising:

a first part including an acidic concentrate having a pH from about 2.8 to about 3.8 that includes dextrose; and

a second part including a lactate-based buffer concentrate having a pH of less than 5.5 wherein the first part and the second part are admixed prior to infusion into a patient.

8. The two part peritoneal dialysis solution of claim 7 wherein the pH of the first part ranges from about 3.0 to about 3.5.

9. The two part peritoneal dialysis solution of claim 7 wherein the acidic concentrate further includes calcium chloride and magnesium chloride.

10. The two part peritoneal dialysis solution of claim 7 wherein the lactate-based buffer concentrate has pH that ranges from about 5.0 to less than 5.5.

11. The two part peritoneal dialysis solution of claim 7 wherein the acidic concentrate includes about 30.0 g/L to about 85.0 g/L of dextrose, calcium chloride dihydrate, and magnesium chloride hexahydrate.

12. The two part peritoneal dialysis solution of claim 11 wherein the acidic concentrate includes about 7.0 mEq/L of calcium.

13. The two part peritoneal dialysis solution of claim 11 wherein the acidic concentrate includes about 5.0 mEq/L of calcium.

14. The two part peritoneal dialysis solution of claim 7 wherein the lactate-based buffer concentrate includes sodium chloride and sodium lactate.

15. A two part peritoneal dialysis solution comprising:

a first part housed in a first structure, the first part including an acidic dextrose concentrate having a pH of about 2.8 to about 3.8; and

a second part housed in a second structure, the second part including an acidic buffer concentrate wherein the first part and the second part are separately sterilized and admixed to form a ready-to-use peritoneal dialysis solution, and wherein the second part has a pH that is less than 5.5.

16. The two part peritoneal dialysis solution of claim 15 wherein the first part and the second part are stored in a multi-chamber container including the first structure and the second structure adaptedly coupled such that the first pan and the second part are capable of mixing to form the mixed solution prior to infusion into the patient.

17. The two part peritoneal dialysis solution of claim 15 wherein the first structure and the second structure each include a solution bag capable of being coupled to an admix device allowing mixing of the first part and the second part to form the mixed solution.

18. The two part peritoneal dialysis solution of claim 15 wherein the ready-to-use peritoneal dialysis solution includes about 1.5% to about 4.25% of dextrose.

19. The two part peritoneal dialysis solution of claim 18 wherein the ready-to-use peritoneal dialysis solution further includes sodium, calcium, chloride, magnesium and lactate.

20. The two part peritoneal dialysis solution of claim 15 wherein the acidic dextrose concentrate includes dextrose, calcium chloride and magnesium chloride.

21. A method of producing a dialysis solution, the method comprising the steps of:

formulating an acidic concentrate and a buffer concentrate having a pH of less than 5.5 wherein the acidic concentrate at least includes dextrose and having a pH of about 2.8 to about 3.8;

separately sterilizing the acidic concentrate and the buffer concentrate; and

mixing the acidic concentrate and the buffer concentrate.

22. The method of claim 21 wherein the acidic concentrate and the buffer concentrate are each housed in a respective chamber of a multi-chambered container adaptedly coupled such that the acidic concentrate and the lactate-based buffer concentrate can be mixed within the multi-chambered container.

23. The method of claim 21 wherein the acidic concentrate and the buffer concentrate are each housed in a respective solution bag each capable of being coupled to an admix device allowing mixing of the acidic concentrate and the lactate-based buffer concentrate.

24. The method of claim 21 wherein the acidic concentrate further includes calcium chloride and magnesium chloride.

25. The method of claim 21 wherein the buffer concentrate includes a lactate-based concentrate at a pH that ranges from about 5.0 to less than 5.5.

26. A method of modifying a standard dialysis solution comprising the steps of:

formulating two or more solution parts of the standard dialysis solution wherein the solution parts at least include a dextrose concentrate and a buffer concentrate;

separately sterilizing the dextrose concentrate at a pH of 2.8 to about 3.8 and the buffer concentrate at a pH of less than 5.5; and

mixing the dextrose concentrate and the buffer concentrate to produce a modified standard dialysis solution.

27. The method of claim 26 wherein the modified standard dialysis solution includes fewer glucose degradation products than the standard dialysis solution.

28. The method of claim 27 wherein the glucose degradation products are selected from the group consisting of 5-hydroxymethyl furfural, 3-deoxyglucasone, glyoxal, methylglyoxal, acetaldehyde and combinations thereof.

29. The method of claim 26 wherein the modified standard dialysis solution includes a solution composition that is substantially the same as the standard dialysis solution except for the glucose degradation products.

30. The method of claim 26 wherein the modified standard dialysis solution includes about 1.5% to about 4.25% of dextrose.

31. The method of claim 26 wherein the modified standard dialysis solution further includes sodium, calcium, magnesium, chloride, and lactate.

32. The method of claim 26 wherein the buffer concentrate includes a lactate-based concentrate.

33. The method of claim 32 wherein the lactate-based Concentrate includes sodium lactate and sodium chloride.

34. The method of claim 26 wherein the dextrose concentrate includes dextrose, calcium chloride and magnesium chloride.

35. A method of providing dialysis to a patient comprising the steps of:

mixing an acidic dextrose concentrate and an acidic buffer solution to form a ready-to-use dialysis solution wherein the acidic dextrose concentrate and the acidic buffer concentrate are separately sterilized prior to mixing and wherein the acidic buffer concentrate has a pH that is less than 5.5 and the acidic dextrose concentrate has a pH of from about 2.8 to about 3.8; and

using the ready-to-use dialysis solution during dialysis.

36. The method of claim 35 wherein the ready-to-use dialysis solution is used as a dialysate.

37. The method of claim 35 wherein the ready-to-use dialysis solution is infused into the patient during peritoneal dialysis.

38. The method of claim 35 wherein the acidic dextrose concentrate includes dextrose, calcium chloride, and magnesium chloride.