Forming a sealed package with a frozen aliquot

Abstract

A cartridge for use with a beneficial agent delivery device having a fillable reservoir. The cartridge includes a reconstitution, unit dose package having first and second compartments, and a fitment. The first compartment contains at least a first constituent of the beneficial agent. The second compartment contains at least a second constituent of the beneficial agent. The fitment is disposed on the package for interfacing the package to the fillable reservoir.

What is claimed is: 
     
         1 . A method of forming a package, comprising:
 introducing a frozen aliquot of a substance in solid form into a compartment of the package;   hermetically sealing the compartment to enclose the frozen aliquot within the package; and   controlling the sealing operation of the package such that the frozen aliquot remains substantially solid throughout the sealing operation.   
     
     
         2 . The method of  claim 1 , further comprising:
 freezing the substance to create the frozen aliquot.   
     
     
         3 . The method of  claim 2 , wherein the substance comprises a metered unit dose of a beneficial agent, and wherein the frozen aliquot comprises a frozen dose of the beneficial agent. 
     
     
         4 . The method of  claim 2 , wherein the substance comprises a first constituent of a beneficial agent. 
     
     
         5 . The method of  claim 1 , wherein the compartment comprises a pre-formed cavity defining a compartment shape. 
     
     
         6 . The method of  claim 5 , wherein the frozen aliquot has the compartment shape. 
     
     
         7 . The method of  claim 5 , further comprising:
 freezing the substance in a mold substantially conforming to the compartment shape to create the frozen aliquot.   
     
     
         8 . The method of  claim 7 , wherein the mold comprises the pre-formed cavity of the compartment. 
     
     
         9 . The method of  claim 8 , further comprising:
 forming the pre-formed cavity in a web material prior to the freezing operation.   
     
     
         10 . The method of  claim 7 , further comprising:
 removing the frozen aliquot from the mold; and   transferring the frozen aliquot to the pre-formed cavity of the compartment, wherein the frozen aliquot is maintained frozen during the removing operation, the transferring operation, the introducing operation, and the sealing operation.   
     
     
         11 . The method of  claim 1 , further comprising:
 inspecting the frozen aliquot for a controlled property prior to the introducing operation.   
     
     
         12 . The method of  claim 1 , further comprising:
 thawing the frozen aliquot after the sealing operation to provide the substance in a sealed compartment of the package at room temperature.   
     
     
         13 . The method of  claim 1 , wherein the compartment of the package is formed in a first wall, and wherein the sealing operation comprises sealing the first wall to a second wall to define a sealed compartment containing the frozen aliquot. 
     
     
         14 . The method of  claim 13 , wherein the first wall is heat sealed to the second wall. 
     
     
         15 . The method of  claim 14 , wherein the controlling the sealing operation of the package comprises managing heat transfer into the package during heat sealing of the first wall to the second wall. 
     
     
         16 . The method of  claim 15 , wherein the managing the heat transfer comprises applying a temperature to the frozen aliquot that is sufficiently to prevent substantial thawing prior to completion of the sealing operation. 
     
     
         17 . The method of  claim 1 , wherein the package further comprises a fitment that is configured to interface to a fillable reservoir of a delivery device. 
     
     
         18 . The method of  claim 17 , further comprising:
 interfacing the fitment with the fillable reservoir of the delivery device after the thawing operation to transfer the substance from the sealed compartment to the fillable reservoir.   
     
     
         19 . The method of  claim 18 , further comprising:
 rupturing a frangible seal between the fitment and the sealed compartment to establish fluid communication between the compartment and the fitment.   
     
     
         20 . The method of  claim 1 , wherein at least a portion of the compartment is formed by a flexible pre-formed wall in a shape of a tube. 
     
     
         21 . The method of  claim 1 , wherein the substance comprises a fluid at room temperature. 
     
     
         22 . The method of  claim 1 , wherein the substance one or more of a fluid, a liquid, a solution, a suspension, a paste, a gel, or a slurry.