Method and Package for Storing a Pressurized Container Containing a Drug

Abstract

A method and package for storing a pressurized container which is filled with a drug formulation at a predetermined pressure. The drug formulation includes a mixture of a drug and a propellant. The package which encloses the pressurized container substantially prevents ingression of water vapor and particulate matter into the package while permitting egression of the propellant which may leak from the pressurized container.

1 - 71 . (canceled)  
   
   
       72 . A drug product comprising: 
 a container containing a pressurized drug formulation comprising a propellant and a drug dispersed and/or dissolved in said propellant; and    an overwrap constructed from a moisture impermeable, flexible material enclosing said container.    
   
   
       73 . The drug product of  claim 72 , further comprising a desiccant located within said overwrap.  
   
   
       74 . The drug product of  claim 73 , wherein said desiccant is selected from the group consisting of molecular sieve zeolite, alumina, silica gel, bauxite, anhydrous calcium sulphate, water-absorbing clay, activated bentonite clay, and combinations thereof.  
   
   
       75 . The drug product of  claim 73 , wherein the desiccant is contained with a sachet.  
   
   
       76 . The drug product of  claim 75 , wherein the desiccant is silica gel.  
   
   
       77 . The drug product of  claim 76 , comprising in the range of 1 to 10 grams silica gel.  
   
   
       78 . The drug product of  claim 72 , further comprising a desiccant placed loosely in the container or as part of an assembly attached to the container.  
   
   
       79 - 89 . (canceled)  
   
   
       90 . The drug product of  claim 72  further including a metering valve engaged to the container.  
   
   
       91 . The drug product of  claim 90  further including an actuator adapted to engage the metering valve and the container.  
   
   
       92 . The drug product of  claim 91  wherein the actuator, metering valve and container are contained within the overwrap.  
   
   
       93 . The drug product of  claim 72  wherein the drug formulation consists essentially of a drug and a hydrofluoroalkane propellant.  
   
   
       94 . The drug product of  claim 72  wherein the overwrap is vacuum sealed.  
   
   
       95 . The drug product of  claim 94  wherein the overwrap is purged with nitrogen gas.  
   
   
       96 - 125 . (canceled)