Packaging for oxygen-sensitive pharmaceutical products

Abstract

The present invention relates to packaging and containers for oxygen-sensitive pharmaceutical products, or oxygen- and moisture-sensitive pharmaceutical products. More particularly, the invention relates to pharmaceutical packages comprising a blister pack with airflow channels and outlets, an oxygen scavenger, and, optionally, a desiccant, all of which are sealed inside an outer container having oxygen and moisture barrier properties.

1 - 51 . (canceled) 
     
     
         52 . A package for an oxygen-sensitive pharmaceutical product, comprising:
 (a) a sealed outer container having oxygen-barrier properties;   (b) a blister pack, disposed inside of the sealed outer container, the blister pack comprising
 (i) at least one outlet that permits gases to pass out of the blister pack and into the sealed outer container, 
 (ii) a shaped film comprising
 (A) at least one cavity configured to hold a single unit dose of the pharmaceutical product, and 
 (B) at least one airflow channel, coupling the cavity to the outlet, that permits oxygen located in the cavity to pass out of the cavity, into the airflow channel and through the outlet, and 
 
 (iii) a frangible lidding sealed to the shaped film so that the single unit dose is substantially confined between said frangible lidding and said at least one cavity; and 
   (c) an oxygen scavenger disposed on the inside of the sealed outer container and the outside of the blister pack;   (d) whereby said oxygen scavenger removes a sufficient amount of oxygen from inside the sealed outer container to maintain an oxygen concentration level of less than 1% by volume for a period of at least 1 year.   
     
     
         53 . The package of  claim 52 , wherein the oxygen concentration level inside the sealed outer container is reduced to less than 1% by volume within 14 days after the sealed outer container is sealed. 
     
     
         54 . The package of  claim 52 , wherein the oxygen absorption capacity of the oxygen scavenger is not greater than 150 cc at 40° C. 
     
     
         55 . The package of  claim 52 , further comprising a desiccant disposed on the inside of the sealed outer container and the outside of the blister pack. 
     
     
         56 . The package of  claim 55 , wherein:
 (a) the sealed outer container has moisture barrier properties;   (b) the airflow channel further permits moisture located in the cavity to pass out of the cavity, into the airflow channel and through the outlet, and   (c) said desiccant removes a sufficient amount of moisture from inside the sealed outer container to maintain a relative humidity of less than 25% for a period of at least 1 year.   
     
     
         57 . The package of  claim 52 , wherein the sealed outer container comprises aluminum, nylon, polyvinyl chloride, polyethylene terephthalate, linear low density polyethylene, polypropylene, or a combination thereof. 
     
     
         58 . The package of  claim 52 , wherein the oxygen transmission rate of the sealed outer container is less than about 0.0017 ccs per package per day at 25° C., 60% relative humidity, and a driving force of 100% oxygen. 
     
     
         59 . The package of  claim 52 , wherein the blister pack comprises a plurality of outlets that permit gases to pass out of the blister pack and into the sealed outer container. 
     
     
         60 . The package of  claim 52 , wherein an active pharmaceutical ingredient in the pharmaceutical product comprises amorphous atorvastatin. 
     
     
         61 . The package of  claim 52 , wherein an active pharmaceutical ingredient in the pharmaceutical product comprises simvastatin. 
     
     
         62 . A package for an oxygen-sensitive pharmaceutical product, comprising:
 (a) a sealed outer container having oxygen-barrier properties;   (b) a blister pack, disposed inside of the sealed outer container, the blister pack comprising
 (i) a shaped film comprising at least one cavity configured to hold a single unit dose of the pharmaceutical product, said at least one cavity having at least one outlet that permits oxygen to pass out of said at least one cavity and into the sealed outer container, and 
 (ii) a frangible lidding sealed to the shaped film so that the single unit dose is substantially confined between said frangible lidding and said at least one cavity; and 
   (c) an oxygen scavenger disposed on the inside of the sealed outer container and the outside of the blister pack;   (d) whereby said oxygen scavenger removes a sufficient amount of oxygen from inside the sealed outer container to maintain an oxygen concentration level of less than 1% by volume for a period of at least 1 year.   
     
     
         63 . The package of  claim 62 , wherein the oxygen concentration level inside the sealed outer container is reduced to less than 1% by volume within 14 days after the sealed outer container is sealed. 
     
     
         64 . The package of  claim 62 , wherein the oxygen absorption capacity of the oxygen scavenger is not greater than 150 cc at 40° C. 
     
     
         65 . The package of  claim 62 , further comprising a desiccant disposed on the inside of the sealed outer container and the outside of the blister pack. 
     
     
         66 . The package of  claim 65 , wherein:
 (a) the sealed outer container has moisture barrier properties;   (b) said at least one outlet permits moisture located in the cavity to pass out of the cavity and into the sealed outer container; and   (c) said desiccant removes a sufficient amount of moisture from inside the sealed outer container to maintain a relative humidity of less than 25% for a period of at least 1 year.   
     
     
         67 . The package of  claim 62 , wherein the sealed outer container comprises aluminum, nylon, polyvinyl chloride, polyethylene terephthalate, linear low density polyethylene, polypropylene, or a combination thereof. 
     
     
         68 . The package of  claim 62 , wherein the oxygen transmission rate of the sealed outer container is less than about 0.0017 ccs per package per day at 25° C., 60% relative humidity, and a driving force of 100% oxygen. 
     
     
         69 . The package of  claim 62 , wherein the shaped film comprises polyvinyl chloride, polyvinylidene chloride, polycarbonate, polyester, copolyester, acrylonitrile, low density polyethylene, polypropylene, or a combination thereof. 
     
     
         70 . The package of  claim 62 , wherein an active pharmaceutical ingredient in the pharmaceutical product comprises amorphous atorvastatin. 
     
     
         71 . The package of  claim 62 , wherein an active pharmaceutical ingredient in the pharmaceutical product comprises simvastatin.