CONTAINER AND METHOD OF MANUFACTURE OF CONTAINER

Abstract

A pre-loaded container and a method of manufacturing a preloaded vial is provided wherein one or more active agents is lyophilized within the vial cap and the vial cap is then sealed onto a vial retaining a suitable diluent to form the pre-loaded vial. Lyophilizing 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 lyophilized one or more active agents and the diluent may be stored efficiently, and that the one or more active agents may be solubilized in a sterile and efficient manner.

Claims

1. A method of manufacturing a pre-loaded container for use in dispensing one or more active agents, the method comprising 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 including an opened end facing the recess of the closure and a closed end opposite the opened end, the piston further including at least one aperture defined by the closed end and extending through the piston to the open end to allow the recess of the closure to be ventilated during lyophilization; lyophilizing 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; adding a suitable diluent to the container; and sealing the container with the closure.

2. The method according to claim 1, wherein the container is a vial and the closure is a vial cap.

3. The method according to claim 1, wherein at least one of the one or more active agents is a biologic.

4. The method according to claim 1, wherein at least one of the one or more active agents is a vaccine.

5. The method according to claim 1, wherein the closure is sterilized before the solution is added to the closure.

6. The method according to claim 1, wherein an interior of the container and an interior of the closure are sterile after the container is sealed with the closure.

Description

DESCRIPTION OF THE DRAWINGS

[0043] An example embodiment of the present invention will now be illustrated with reference to the following Figures in which: FIGS. 1a and 1b are side views of a pre-loaded vial (FIG. 1a) as stored and (FIG. 1b) after the one or more active agents have been applied to the diluent; and

[0044] FIG. 2 is a scheme of the method of manufacture of a pre-loaded vial.

DETAILED DESCRIPTION OF AN EXAMPLE EMBODIMENT

[0045] With reference to FIGS. 1a and 1b, a pre-loaded vial 1 comprises a vial (acting as a container) 2 and a vial cap 4 (acting as a closure). The vial cap comprises a piston 6, a base 8 (acting as a frangible member) and a recess 10 retaining a lyophilized vaccine 12 (acting as an active agent). The vial retains a diluent 14 (for example, saline solution) suitable for solubilizing the lyophilized vaccine. The piston of the vial cap defines apertures, which are sealed after manufacture.

[0046] The pre-loaded vial is manufactured by the following method, shown in FIG. 2.

[0047] The vial and vial cap are sterilized. A solution of the vaccine is prepared and one dose of the vaccine is placed into the recess of the vial cap. The recess of the vial cap is then covered by the piston. The apertures defined by the piston allow the recess of the vial cap to be ventilated. The vaccine solution within the vial cap is then lyophilized. That is, the vaccine solution is frozen and then warmed in vacuum to allow solvent in the vial cap to sublime into the vacuum through the apertures defined by the piston, leaving the vaccine protein behind in the vial cap. The advantage of lyophilization is that the vaccine protein left behind in the vial cap is not structurally altered and is much more stable than the solubilized vaccine.

[0048] The vial cap is then sealed such that the apertures of the piston are sealed and the recess of the vial cap is sealed to ensure that the lyophilized vaccine retained within the recess remains sterile.

[0049] The diluent is added to the vial. The vial cap is then sealed to the vial such that the diluent within the vial is sealed from the outside and that the lyophilized vaccine is sealed from the diluent in the vial and the outside, thereby ensuring that the diluent and vaccine are retained in sterile conditions.

[0050] A pre-loaded vial prepared by the above method may then be stored within a refrigerator or according to its recommended storage conditions to await use.

[0051] With reference to FIGS. 1a and 1b, during use, the piston of the vial cap is pressed by the user (FIG. 1a) such that the piston moves through and extends beyond the base of the vial cap, thereby breaking the said base and allowing the lyophilized vaccine to fall into the diluent within the vial (FIG. 1b). The vial is then agitated to ensure that the vaccine is fully solubilized. The vaccine is then ready for use, and may be extracted by piercing the seal of the piston of the vial cap with a syringe and drawing the newly solubilized vaccine into the syringe after sterilization of the outer surface of the vial cap.

[0052] In alternative embodiments, a lyophilized biologic may be stored in the pre-loaded vial using the method of the present invention for storage within a refrigerator or according to its recommended storage conditions.

[0053] In further alternative embodiments, the piston may move from a first position to a second position such that the piston displaces the base of the vial, thereby allowing the lyophilized active agent resting on the said base to fall into the diluent in the vial. For example, the base may be hinged such that the base is moved from a horizontal orientation to a vertical orientation such that the lyophilized active agent falls into the diluent.

[0054] Further modifications and variations may be made within the scope of the invention herein disclosed.