Method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis

1. A method for preparing a medical solution, comprising the steps of:

a) providing a solution comprising one or more acetylated or deacetylated amino sugars in at least one compartment of a container, said solution having a pH of 2.5-3.5, and

b) terminally sterilizing of said at least one compartment and the solution therein to form a terminally sterilized solution, wherein the terminally sterilized solution contains low levels of cytotoxic degradation products; and wherein the one or more acetylated or deacetylated amino sugars is N-acetylglucosamine.

2. The method according to claim 1 , wherein said N-acetylglucosamine is present in a concentration of 15-40% by weight with respect to the weight of the solution in said at least one compartment.

3. The method according to claim 2 , wherein said N-acetylglucosamine is present in a concentration of 20-40% by weight with respect to the weight of the solution in said at least one compartment.

4. The method according to claim 3 , wherein said N-acetylglucosamine is present in a concentration of at least 30% by weight with respect to the weight of the solution in said at least one compartment.

5. The method according to claim 1 , wherein the terminal sterilisation is heat sterilisation at a temperature of at least 100° C.

6. The method according to claim 5 , wherein the terminal sterilisation is heat sterilisation at a temperature of 121° C.

7. The method according to claim 1 , wherein each compartment of the container is delimited from other compartments during the terminal sterilisation, and wherein the terminally sterilised solution containing N-acetylglucosamine is mixed with a terminally sterilised pH adjusting and diluting solution in at least one other terminally sterilised compartment of the container, thereby finally preparing the medical solution.

8. The method according to claim 7 , wherein the pH in the finally prepared medical solution is 6.0-8.0.

9. The method according to claim 8 , wherein the pH in the finally prepared medical solution is 7.4.

10. The method according to claim 7 , wherein the concentration of N-acetylglucosamine in the finally prepared solution is 0.2-15.0% by weight.

11. The method according to claim 10 , wherein the concentration of N-acetylglucosamine in the finally prepared solution is 0.5-6.0% by weight.

12. The method according to claim 1 , wherein physiologically compatible constituents in the form of carbohydrates, proteins, peptides, and antioxidants are present in one or more of said compartments.

13. The method according to claim 12 , wherein the carbohydrate is glucose.

14. The method according to claim 1 , wherein the medical solution prepared is a peritoneal dialysis solution.

15. The method according to claim 1 , wherein the pH is 3.0.

16. The method according to claim 1 , wherein the terminal sterilisation is radiation sterilisation.

17. A method for preparing a medical solution, comprising the steps of:

a) providing a solution comprising one or more acetylated or deacetylated amino sugars in at least one compartment of a container, said solution having a pH of 2.5-3.5, and

b) terminally sterilizing of said at least one compartment and the solution therein to form a terminally sterilized solution, wherein the terminally sterilized solution results in lower levels of inhibition of cell growth compared to a solution terminally sterilized at a pH outside the range of 2.5-3.5, and wherein the one or more acetylated or deacetylated amino sugars is N-acetylglucosamine.