Plastic containers

Abstract

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 solution comprising gadolinium-DOTA wherein said method comprises:
 (i) manufacturing a commercial batch of said solution; and,   (ii) dispensing said solution into plastic containers.   
     
     
         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 solution comprising gadolinium-DOTA 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 plastic containers are made from pharmaceutical-grade cyclic olefin 
     
     
         5 . The method as defined in  claim 1  wherein said plastic containers are made from pharmaceutical-grade polypropylene. 
     
     
         6 . The method as defined in  claim 1  wherein said plastic container is a syringe. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The method as defined in  claim 1  wherein said plastic container is a bottle. 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . The method as defined in  claim 1  wherein said plastic container is a bag. 
     
     
         14 . (canceled) 
     
     
         15 . The method as defined in  claim 1  wherein said commercial batch is a 400-1400 L batch. 
     
     
         16 . The method as defined in  claim 1  wherein said method further comprises the step (iii) of storing said solution dispensed into said plastic containers. 
     
     
         17 . The method as defined in  claim 16  wherein said storing is for more than 90 days. 
     
     
         18 . The method as defined in  claim 17  wherein said storing is for up to 30 months. 
     
     
         19 . The method as defined in  claim 17  wherein said storing is for up to 36 months. 
     
     
         20 . The method as defined in  claim 1  wherein said storing is at temperatures up to 30° C. 
     
     
         21 . The method as defined in  claim 1  wherein said dispensing includes an overfill. 
     
     
         22 . The method as defined in  claim 21  wherein said overfill is 1-5% of the final desired volume. 
     
     
         23 . The method as defined in  claim 1  wherein nitrogen is not used as an excipient in the plastic container headspace. 
     
     
         24 . A magnetic resonance imaging (MRI) method comprising:
 (a) providing a plastic container containing a solution comprising gadolinium-DOTA wherein said container is as defined  claim 1 ;   (b) administering an imaging effective amount of said solution to a subject; and,   (c) performing MRI on said subject.   
     
     
         25 . A solution comprising gadolinium-DOTA obtained according to the method as defined in  claim 1 . 
     
     
         26 . A plastic container comprising a solution comprising gadolinium-DOTA as defined in  claim 1 .