Destruction of microbial products by enzymatic digestion

• US 8,349,813 B2
• Filed: 03/19/2009
• Issued: 01/08/2013
• Est. Priority Date: 03/20/2008
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Johnson, Richard J., Leesch, Valerie, Holmes, Clifford, Wang, Run
• Primary Examiner(s): KAM, CHIH MIN
• Application Number:
  US12/407,516
• Publication Number:
  US 20090239821A1
• Time in Patent Office: 1,391 Days
• Field of Search: 435/4, 435/262, 514/54
• US Class Current: 514/54
• 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

Abstract

Methods of treating a dialysis component by providing a dialysis component and contacting the dialysis component with an enzyme are provided. The enzyme breaks down microbial contaminants in the dialysis component. The enzyme may be separated from the dialysis component to provide a purified dialysis component. The purified dialysis component may be substantially free of microbial contaminants that cause a cytokine response in humans.

Claims

1. A method of treating a dialysis component, the method comprising:

providing a dialysis component for peritoneal dialysis;

contacting the dialysis component with an enzyme selected from the group consisting of N-acetylmuramyl-L-alanine amidase, lysozyme, amidases, trypsins, chitinases, beta 1-3 glucanases, pronases, proteases, lipases, endoglycosidases and combinations thereof;

allowing the enzyme to break down microbial contaminants in the dialysis component; and

separating the enzyme from the dialysis component to provide a purified dialysis component.

2. The method of claim 1, wherein the purified dialysis component is substantially free of microbial contaminants that cause a cytokine response in humans.

3. The method of claim 1, wherein the enzyme is added at a ratio of between about 0.0005% and about 0.05% by weight of the dialysis component.

4. The method of claim 1, wherein the dialysis component is selected from the group consisting of glucose polymers, hydroxyethyl starch, modified starch and combinations thereof.

5. The method of claim 1 further comprising incubating the dialysis component and the enzyme for a period of time.

6. The method of claim 5, wherein the period of time is at least 1 hour.

7. The method of claim 1, wherein the step of contacting the dialysis component with an enzyme comprises adding to the dialysis component a treatment solution comprising the enzyme.

8. The method of claim 7, wherein the step of separating the enzyme from the dialysis component comprises filtering the enzyme from the dialysis component.

9. The method of claim 8, wherein the enzyme is naturally larger than the molecular weight cut off of the filter.

10. The method of claim 1, wherein the enzyme is fixed to a substrate.

11. The method of claim 10, wherein the substrate is a bead or a membrane.

12. The method of claim 1, wherein the step of contacting the dialysis component with an enzyme is performed in a batch process.

13. The method of claim 1, wherein the step of contacting the dialysis component with an enzyme is performed in a continuous process.

14. The method of claim 1 further comprising the step of testing the dialysis component for the presence of microbial contaminants after the step of allowing the enzyme to break down microbial contaminants in the dialysis component.

15. The method of claim 14, where the testing is interleukin-6 testing.

16. The method of claim 1, wherein the dialysis component includes peptidoglycan as a microbial contaminant.

17. The method of claim 1, wherein the dialysis component is icodextrin.

18. A method of treating a peritoneal dialysis solution, the method comprising:

providing a peritoneal dialysis solution comprising a glucose polymer, hydroxyethyl starch or modified starch;

contacting the peritoneal dialysis solution with an enzyme selected from the group consisting of N-acetylmuramyl-L-alanine amidase, lysozyme, amidases, trypsins, chitinases, beta 1-3 glucanases, pronases, proteases, lipases, endoglycosidases and combinations thereof;

allowing the enzyme to break down microbial contaminants in the peritoneal dialysis solution; and

separating the enzyme from the peritoneal dialysis solution to provide a purified peritoneal dialysis solution.

19. The method of claim 18, wherein the step of contacting the peritoneal dialysis solution with an enzyme comprises adding to the peritoneal dialysis solution a treatment solution comprising the enzyme.

20. The method of claim 18, wherein the step of separating the enzyme from the peritoneal dialysis solution comprises filtering the enzyme from the peritoneal dialysis solution.

21. A method of providing peritoneal dialysis to a patient, the method comprising:

providing a peritoneal dialysis component comprising a glucose polymer, hydroxyethyl starch or modified starch;

contacting the peritoneal dialysis component with an enzyme selected from the group consisting of N-acetylmuramyl-L-alanine amidase, lysozyme, amidases, trypsins, chitinases, beta 1-3 glucanases, pronases, proteases, lipases, endoglycosidases and combinations thereof;

allowing the enzyme to break down microbial contaminants in the peritoneal dialysis component;

separating the enzyme from the peritoneal dialysis component to provide a purified peritoneal dialysis component;

using the purified peritoneal dialysis component to make a peritoneal dialysis solution; and

using the peritoneal dialysis solution in a treatment of a patient.