Peritoneal dialysis solutions comprising glucose polymers
View Patent ↗Peritoneal dialysis solutions including a glucose polymer and methods of using the dialysis solutions are disclosed herein. In a general embodiment, the peritoneal dialysis solution includes a glucose polymer in an amount to provide an increased ultrafiltration fluid volume for a given amount of carbohydrate absorbed compared to conventional dialysis solutions containing icodextrin as the active pharmaceutical ingredient. The increased ultrafiltration fluid volume for a given amount of carbohydrate absorbed is obtained by providing specific combinations of weight-average molecular weight, polydispersity index and concentration of the glucose polymer in the dialysis solution.
1. A dialysis solution comprising from about 7% w/v to about 10.5% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 7,500 daltons to about 11,500 daltons and wherein:
(a) if y=about 7,500 daltons to about 8,500 daltons, then z=about 1.5 to about 1.7;
(b) if y=about 8,501 daltons to about 9,500 daltons, then z=about 1.7 to about 1.9; or
(c) if y=about 10,500 daltons to about 11,500 daltons, then z=about 2.1 to about 2.3.
2. The dialysis solution of claim 1 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
3. The dialysis solution of claim 2 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
4. The dialysis solution of claim 2 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
5. The dialysis solution of claim 1 , wherein the dialysis solution is sterilized.
6. A dialysis solution comprising from about 7% w/v to about 15% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 9,500 daltons to about 13,500 daltons and wherein: (a) if y=about 8,500 daltons to about 9,500 daltons, then z =about 1.5 to about 1.7; (b) if y=about 9,501 daltons to about 10,500 daltons, then z=about 1.5 to about 1.9; (c) if y=about 10,501 daltons to about 11,500 daltons, then z=about 1.5 to about 2.1; (d) if y=about 11,501 daltons to about 12,500 daltons, then z=about 1.7 to about 2.3; or (e) if y=about 12,501 daltons to about 13,500 daltons, then z=about 1.9 to about 2.5.
7. The dialysis solution of claim 6 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
8. The dialysis solution of claim 7 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
9. The dialysis solution of claim 7 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
10. The dialysis solution of claim 6 , wherein the dialysis solution is sterilized.
11. A dialysis solution comprising from about 8% w/v to about 15% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 11,500 daltons to about 19,500 daltons and wherein: (a) if y=about 11,500 daltons to about 12,500 daltons, then z=about 1.5 to about 1.7; (b) if y=about 12,501 daltons to about 13,500 daltons, then z=about 1.5 to about 1.9; (c) if y=about 13,000 daltons to 14,000 daltons, then z=1.6-2.0; (d) if y=14,000 daltons to 15,000 daltons, then z=1.6-2.0; (e) if y=about 15,501 daltons to about 16,500 daltons, then z=about 1.7 to about 2.5; (f) if y=about 16,501 daltons to about 17,500 daltons, then z=about 1.9 to about 2.5; (g) if y=about 17,501 daltons to about 18,500 daltons, then z=about 2.1 to about 2.5; or (h) if y=about 18,501 daltons to about 19,500 daltons, then z=about 2.3 to about 2.5.
12. The dialysis solution of claim 11 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
13. The dialysis solution of claim 12 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
14. The dialysis solution of claim 12 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
15. The dialysis solution of claim 11 , wherein the dialysis solution is sterilized.
16. A dialysis solution comprising from about 9% w/v to about 15% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 15,500 daltons to about 23,500 daltons and wherein:
(a) if y=about 15,501 daltons to about 16,500 daltons, then z=about 1.5 to about 1.7;
(b) if y=about 16,501 daltons to about 17,500 daltons, then z=about 1.5 to about 1.9;
(c) if y=about 17,501 daltons to about 18,500 daltons, then z=about 1.5 to about 2.1;
(d) if y=about 18,501 daltons to about 19,500 daltons, then z=about 1.5 to about 2.3;
(e) if y=about 19,501 daltons to about 20,500 daltons, then z=about 1.7 to about 2.5;
(f) if y=about 20,501 daltons to about 21,500 daltons, then z=about 1.7 to about 2.5;
(g) if y=about 21,501 daltons to about 22,500 daltons, then z=about 1.9 to about 2.5; or
(h) if y=about 22,501 daltons to about 23,500 daltons, then z=about 2.3 to about 2.5.
17. The dialysis solution of claim 16 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
18. The dialysis solution of claim 17 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
19. The dialysis solution of claim 17 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
20. The dialysis solution of claim 16 , wherein the dialysis solution is sterilized.
21. A dialysis solution comprising from about 10% w/v to about 15% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 19,500 daltons to about 24,500 daltons and wherein:
(a) if y=about 19,501 daltons to about 20,500 daltons, then z=about 1.5 to about 1.7;
(b) if y=about 20,501 daltons to about 21,500 daltons, then z=about 1.5 to about 1.7;
(c) if y=about 21,501 daltons to about 22,500 daltons, then z=about 1.5 to about 1.9;
(d) if y=about 22,501 daltons to about 23,500 daltons, then z=about 1.5 to about 2.1; or
(e) if y=about 23,501 daltons to about 24,500 daltons, then z=about 1.7 to about 2.1 or about 2.3 to about 2.5.
22. The dialysis solution of claim 21 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
23. The dialysis solution of claim 22 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
24. The dialysis solution of claim 22 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
25. The dialysis solution of claim 21 , wherein the dialysis solution is sterilized.
26. A dialysis solution comprising from about 7% w/v to about 12.5% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, wherein y is from about 9,500 daltons to about 12,500 daltons and wherein:
(a) if y=about 9,500 daltons to about 10,500 daltons, then z=about 1.9 to about 2.1; or
(b) if y=about 11,500 daltons to about 12,500 daltons, then z=about 2.3 to about 2.5.
27. The dialysis solution of claim 26 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
28. The dialysis solution of claim 27 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of a KREBS cycle and combinations thereof.
29. The dialysis solution of claim 27 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
30. The dialysis solution of claim 26 , wherein the dialysis solution is sterilized.
31. A dialysis solution comprising from about 13% w/v to about 15% w/v glucose polymer, the glucose polymer having a weight-average molecular weight of y and a polydispersity index of z, y is from about 23,500 daltons to about 24,500 daltons and wherein:
(a) if y =about 23,500 daltons to about 24,500 daltons, then z =about 1.5 to about 1.7.
32. The dialysis solution of claim 31 , wherein the dialysis solution comprises at least one additional dialysis component selected from the group consisting of buffers, electrolytes and combinations thereof.
33. The dialysis solution of claim 32 , wherein the buffer is selected from the group consisting of bicarbonate, lactate, pyruvate, acetate, citrate, amino acids, peptides, an intermediate of the a KREBS cycle and combinations thereof.
34. The dialysis solution of claim 32 , wherein the electrolyte is selected from the group consisting of calcium, magnesium, sodium, potassium, chloride and combinations thereof.
35. The dialysis solution of claim 31 , wherein the dialysis solution is sterilized.
36. A method of preparing a dialysis solution, the method comprising:
selecting a specific Mw from a range of about 7,500 to about 24,500 daltons, a PolyD index and a w/v concentration of a glucose polymer to be used in the dialysis solution selected from a range of about 7% to about 15% w/v; and
providing the glucose polymer at the specified polydispersity index, molecular weight and w/v concentration in the dialysis solution according to claim 1 , 6 , 11 , 16 , 21 , 26 , or 31 .
37. A method of providing dialysis to a patient in need thereof, the method comprising:
selecting a specific Mw from a range of about 7,500 to about 24,500 daltons, a PolyD index and a w/v concentration of a glucose polymer to be used in a dialysis solution selected from a range of about 7% to about 15% w/v;
providing the glucose polymer at the specified polydispersity index, molecular weight and w/v concentration in the dialysis solution according to claim 1 , 6 , 11 , 16 , 21 , 26 , or 31 ; and
administering the dialysis solution to the patient.