Method for obtaining a 2-
View Patent ↗The invention relates to a method for improving one or more physical/chemical characteristics, like reduced radiolysis of and the ability to autoclave, a 18F-fluor-deoxy-glucose (18F-FDG)-solution, which method comprises the steps of a) provision of a 18F-fluor-deoxy-glucose (18F-FDG)-solution, and b) addition of at least one buffer based on a weak acid to the 18F-fluor-deoxy-glucose (18F-FDG)-solution. The invention also relates to a method for preparing a sterile 18F-fluor-deoxy-glucose (18F-FDG)-solution by autoclaving said 18F-fluor-deoxy-glucose (FDG)-solution.
1. A method for improving radiostability of a 18 F-fluor-deoxy-glucose ( 18 F-FDG)-solution during autoclaving, the method comprising:
a) providing a 18 F-fluor-deoxy-glucose ( 18 F-FDG)-solution,
b) adding at least one buffer based on a weak acid to the 18 F-fluor-deoxy-glucose ( 18 F-FDG)-solution, wherein the buffer is selected from the group consisting of citrate, acetate, ascorbate and combinations thereof; and,
c) autoclaving the buffered 18 F-fluor-deoxy-glucose ( 18 F-FDG)-solution.
2. The method according to claim 1 , wherein the buffered 18 F-FDG-solution maintains radiochemical purity after being autoclaved, thus rendering the solution suitable for medical applications.
3. The method according to claim 1 , wherein the pH of the citrate buffer is lower than 5.5.
4. The method according to claim 1 , wherein the pH of the acetate buffer is between 3.0 and 5.5.
5. The method according to claim 1 , wherein the pH of the ascorbate buffer is between 3.0 and 5.5.
6. The method according to claim 1 , wherein the buffered 18 F-fluor-deoxy-glucose (FDG)-solution is autoclaved at a temperature between 110° C. and 145° C.
7. The method according to claim 1 , wherein the buffered 18 F-fluor-deoxy-glucose (FDG)-solution is autoclaved at a temperature between 130° C. and 140° C.
8. The method according to claim 1 , wherein the buffered 18 F-fluor-deoxy-glucose (FDG)-solution is autoclaved at a temperature of 134° C.
9. The method according to claim 6 , wherein autoclaving is performed for a period of 1 to 30 minutes.
10. The method according to claim 6 , wherein autoclaving is performed for a period of 1 to 10 minutes.
11. The method according to claim 6 , wherein autoclaving is performed for a period of 2 to 5 minutes.
12. The method of claim 2 , wherein the radiochemical purity of the buffered 18 F-fluor-deoxy-glucose ( 18 F-FDG)-solution is at least 95%.
13. The method accordingly to claim 12 , wherein the radiochemical purity of the buffered 18 F-FDG-solution is at least about 95% 7.5 hours after being autoclaved.
14. The method according to claim 3 , wherein the pH of the citrate buffer is between 2 and 5.5.