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Claims for Patent: 6,077,836

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Claims for Patent: 6,077,836

Title: Peritoneal dialysis and compositions for use therein
Abstract:A peritoneal dialysis composition containing an osmotic agent comprising a glucose polymer mixture, said mixture including at least 15% by weight of glucose polymers having a D.P. (degree of polymerization) greater than 12. A method is provided for preparing the glucose polymers and a defined sterile aqueous solution of the same for use in peritoneal dialysis by introduction into the abdominal cavity. Also disclosed are methods of treating toxaemia caused by toxins arising from internal disorders of the body, such as hepatic encephalopathy, or which arise from external sources such as poisoning by overdoses of drugs or industrial and agricultural chemicals, e.g., paraquat.
Inventor(s): Milner; Jeremiah (Roscrea, IE)
Assignee: ML Laboratotries, PLC (GB)
Application Number:07/988,023
Patent Claims: 1. An aqueous peritoneal dialysis composition sterile and free from pyrogens which is used for introduction into the abdominal cavity for removal of water and waste products by dialysis across the peritoneal membrane comprising a water soluble glucose polymer mixture derived from the hydrolysis of starch containing at least 36.7% by weight of glucose

polymers having a degree of polymerization (D.P.) of more than 12 glucose units, said glucose polymer mixture being present in the peritoneal dialysis composition as an osmotic agent and said peritoneal dialysis composition having an osmolality of about 265 to 378 mOsm/kg.

2. An agueous peritoneal dialysis composition which is used for introduction into the abdominal cavity for removal of water and waste products by dialysis across the peritoneal membrane comprising a water soluble glucose polymer mixture having an average molecular weight of from 15,000 to 25,000 derived from the hydrolysis of starch containing at least 36.7% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units, said glucose polymer mixture being present in the peritoneal dialysis composition as an osmotic agent.

3. The composition of claim 1 or 2 wherein the average molecular weight of the glucose polymer mixture is from 18,000 to 22,000.

4. The composition of claim 1, 2 or 3 wherein the glucose polymer mixture contains more than 50% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

5. The composition of claim 1, 2 or 3 wherein the glucose polymer mixture contains from 50 to 90% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

6. The composition of claim 1, 2 or 3 wherein the glucose polymer mixture contains from 75 to 100% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

7. The composition of claim 1, 2 or 3 wherein the glucose polymer mixture contains from 90 to 100% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

8. The composition of claim 1, 2 or 3 wherein the agueous peritoneal dialysis composition contains from 2 to 10% w/v of said glucose polymer mixture.

9. The composition of claim 1, 2 or 3 wherein the agueous peritoneal dialysis composition contains from 2 to 4% of w/v of said glucose polymer mixture.

10. The composition of claim 1, 2 or 3 wherein the glucose polymer mixture contains less than 3% by weight of glucose.

11. The composition of claim 1, 2 or 3 wherein the aqueous peritoneal dialysis composition contains from 2 to 15% w/v of said glucose polymer mixture.

12. The composition of claim 1, 2 or 3 wherein the aqueous peritoneal dialysis composition contains from 2 to 5% w/v of said glucose polymer mixture.

13. The composition of claim 1, 2 or 3 wherein the starch contains not more than 5% of 1,6-linkages.

14. The composition of claim 1, 2 or 3 further comprising 116 to 145 mEg/liter of sodium, 0 to 6 mEg/liter of calcium, 90 to 144 mEg/liter of chloride and 1 to 2 of mEg/liter of magnesium.

15. The composition of claim 1, 2 or 3 containing from 0.5 to 25 g/liter of amino acid salts or protein hydrolyzates.

16. A water soluble glucose polymer mixture having an average molecular weight of from 15,000 to 25,000 derived from the hydrolysis of starch and containing at least 36.7% of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

17. The composition of claim 16 wherein the average molecular weight of the glucose polymer mixture is from 18,000 to 22,000.

18. The composition of claim 16 wherein the glucose polymer mixture contains more than 50% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

19. The composition of claim 16 wherein the glucose polymer mixture contains from 50 to 90% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

20. The composition of claim 16 wherein the glucose polymer mixture contains from 75 to 100% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

21. The composition of claim 16 wherein the glucose polymer mixture contains from 90 to 100% by weight of glucose polymers having a degree of polymerization (D.P.) of more than 12 glucose units.

22. The composition of claim 16 wherein the starch contains not more than 5% of 1,6-linkages.
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