Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system

Abstract

The present invention relates to pharmaceutical container systems, and to prefilled container inserts for use therein, for mixing two or more ingredients of a pharmaceutical product. The prefilled container insert of one embodiment comprises a molded container casing having walls, a bottom and an open top for receiving a solid component, a resilient stopper for sealing the open top of the molded container casing, and a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing. The bottom disc is openable to allow mixing of the prefilled solid component with a diluents fluid of the pharmaceutical container system by introducing a spike through the resilient stopper applying a pushing force on the bottom disc, by which force the weakening rim is broken and the container is opened. The prefilled container insert of a further embodiment comprises a molded container casing having walls, a bottom and an open top for receiving an inner open cylinder and a solid component, a resilient stopper for sealing the open top of the molded container casing, and a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing. The bottom disc is openable to allow mixing of the prefilled solid component with a diluents fluid of the pharmaceutical container system by applying a pushing force onto the top of the molded container compressing the casing and forcing the inner cylinder to push on the bottom disc, by which force the weakening rim is broken and the container insert is opened.

1 . A prefilled container insert for use in a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product, the pre-filled container insert comprising:
 a molded container casing having walls, a bottom and an open top for receiving a solid component;   a resilient stopper for sealing the open top of the molded container casing; and   a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by introducing a spike through the resilient stopper applying a pushing force on the bottom disc, by which force the weakening rim is broken and the container insert is opened.   
     
     
         2 . A prefilled container insert for use in a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product, the pre-filled container insert comprising:
 a molded container casing having walls, a bottom and an open top for receiving an inner open cylinder and a solid component;   a resilient stopper for sealing the open top of the molded container casing; and   a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by applying a pushing force onto the top of the molded container, thereby compressing the casing and forcing the inner cylinder towards the bottom disc, by which force the weakening rim is broken and the container insert is opened.   
     
     
         3 . A prefilled container insert according to  claim 2 , wherein the molded container casing has pleated sidewalls forming a bellows container insert. 
     
     
         4 . A prefilled container insert according to  claim 1 , wherein the weakening rim in the bottom disc is arranged around the periphery of the bottom of the container casing forming a hinged disc such that the bottom disc remains connected to the container casing when the weakening rim is broken and the container is opened. 
     
     
         5 . A prefilled container insert according to  claim 1 , wherein the resilient stopper is secured in place by a clamp ring to hermetically seal the top opening. 
     
     
         6 . A pre-filled prefilled container insert according to  claim 1 , wherein the bottom disc is covered by a moisture barrier foil. 
     
     
         7 . A prefilled container insert according to  claim 1 , wherein the resilient stopper is covered by a moisture barrier foil. 
     
     
         8 . A prefilled container insert according to  claim 1 , wherein the prefilled container insert is aseptically mounted into the top of a Blow-Fill-Seal (BFS) container forming a multi-chamber pharmaceutical container system. 
     
     
         9 . A prefilled container insert according to  claim 1 , wherein the prefilled container insert is aseptically mounted into a container, the container having a delivery mechanism capable of attachment thereto, such that there is provided a multi-chamber pharmaceutical delivery system. 
     
     
         10 . A prefilled container insert according to  claim 9 , wherein the delivery mechanism comprises a nasal delivery component, preferably a spray, dropper or the like. 
     
     
         11 . A pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product, comprising:
 a first container comprising a diluents liquid; and   a second container insert aseptically mounted into the top of the first container, the second container including:
 a molded container casing for receiving a solid component; 
 a resilient stopper for sealing the open top of the molded container casing; and 
 a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing, wherein the bottom disc is openable to allow mixing of the prefilled solid component with a diluents fluid of the pharmaceutical container system by introducing a spike through the resilient stopper applying a pushing force on the bottom disc, by which force the weakening rim is broken and the container is opened. 
   
     
     
         12 . A pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product, comprising:
 a first container comprising a diluents liquid; and   a second container insert aseptically mounted into the top of the first container, the second container including:
 a molded container casing having walls, a bottom and an open top for receiving an inner open cylinder and a solid component; 
 a resilient stopper for sealing the open top of the molded container casing; and 
 a bottom disc formed by a weakening rim in the bottom periphery of the molded container casing, wherein the bottom disc is openable to allow mixing of the prefilled solid component with a diluents fluid of the pharmaceutical container system by applying a pushing force onto the top of the molded container, thereby compressing the casing and forcing the inner cylinder towards the bottom disc, by which force the weakening rim is broken and the container insert is opened.