Plastic containers
The present invention provides a method for the commercial presentation of a solution of gadolinium-DOTA that provides certain advantages over the known methods.
1. A method for providing a gadolinium-DOTA solution wherein said method comprises:
(i) manufacturing a batch of said gadolinium-DOTA solution; and,
(ii) dispensing said gadolinium-DOTA solution into a pharmaceutical-grade cyclic olefin plastic container, wherein said container is a syringe;
wherein said syringe comprises oxygen in the headspace of the syringe and is sufficiently transparent to permit visual verification of the contents of the syringe.
2. The method as defined in claim 1 wherein said gadolinium-DOTA is the meglumine salt of gadolinium-DOTA.
3. The method as defined in claim 1 wherein said gadolinium-DOTA solution further comprises a mol/mol amount of free DOTA between 0.002% and 0.4%.
4. The method as defined in claim 1 wherein said syringe has a 10 mL volume.
5. The method as defined in claim 1 wherein said syringe has a 15 mL volume.
6. The method as defined in claim 1 wherein said syringe has a 20 mL volume.
7. The method as defined in claim 1 wherein said batch is a 400-1400L batch.
8. The method as defined in claim 1 wherein said method further comprises the step (iii) of storing said solution dispensed into said plastic containers.
9. The method as defined in claim 8 wherein said storing is for more than 90 days.
10. The method as defined in claim 8 wherein said storing is for up to 30 months.
11. The method as defined in claim 8 wherein said storing is for up to 36 months.
12. The method as defined in claim 8 wherein said storing is at temperatures up to 30° C.
13. The method as defined in claim 1 wherein said dispensing includes an overfill.
14. The method as defined in claim 13 wherein said overfill is 1-5% of the final desired volume.
15. The method as defined in claim 1 wherein nitrogen is not used as an excipient in the plastic container headspace.