Container and Method of Manufacture of Container

Abstract

A pre-loaded container and a method of manufacturing a pre-loaded vial is provided wherein one or more active agents is lyophilised within the vial cap and the vial cap is then sealed onto a vial retaining a suitable diluent to form the pre-loaded vial. Lyophilising the one or more active agents within the vial cap ensures that the one or more active agents are retained in sterile conditions, that the lyophilised one or more active agents and the diluent may be stored efficiently, and that the one or more active agents may be solubilised in a sterile and efficient manner.

1 . A method of manufacturing a pre-loaded container for use in dispensing one or more active agents comprising the steps of;
 providing a container, a closure having a recess, and a solution containing one or more active agents;   adding a portion of the solution into the recess of the closure;   covering the closure with a sealing element comprising a piston, the piston having at least one aperture to allow the recess of the closure to be ventilated during the step of lyophilisation;   lyophilising the solution in the recess of the closure;   sealing the closure by sealedly mounting the sealing element to the closure such that the at least one aperture of the piston is sealed, thereby sealing the recess of the closure; and   adding a suitable diluent to the container and sealing the container with the closure.   
     
     
         2 . A method according to  claim 1 , wherein the container is a vial and the closure is a vial cap. 
     
     
         3 . A method according to any one preceding claim, wherein at least one of the one or more active agents is a biologic. 
     
     
         4 . A method according to any one preceding claim, wherein at least one of the one or more active agents is a vaccine. 
     
     
         5 . A method according to any one preceding claim, wherein the closure is sterilised before the solution is added to it. 
     
     
         6 . A method according to any one preceding claim, wherein the interior of the container and the interior of the closure are sterile after the container is sealed to the closure. 
     
     
         7 . A method according to any one preceding claim, wherein immediately preceding the step of lyophilising the solution in the closure, the closure is covered. 
     
     
         8 . A pre-loaded container comprising a container body and a closure; the closure having a recess, a frangible member and a piston arranged adjacent to the frangible member; the container body retaining a diluent and the closure recess retaining one or more active agents lyophilised within the closure by the method of any one of  claims 1  to  7 ; wherein the piston of the closure may be moved from a first position to a second position so that in the second position the piston breaks and extends beyond the frangible member such that the lyophilised one or more active agents is combined with the diluent. 
     
     
         9 . A pre-loaded container according to  claim 8 , wherein the piston of the closure is manually operable between the first position and the second position. 
     
     
         10 . A pre-loaded container according to either one of  claim 8  or  9 , wherein the closure recess retains a cake or tablet of lyophilised active agent such that when the piston is moved from the first position to the second position the cake or tablet of lyophilised active agent is combined with the diluent.