Package and device for simultaneously maintaining low moisture and low oxygen levels

Abstract

The present invention relates to a device for reducing the oxygen content of the air surrounding pharmaceutical dosage forms contained within an oxygen-permeable bottle, while also maintaining a relatively low moisture level in said air during the shelf-life of the product. Accordingly, a pharmaceutical package contains a dessicant in a first sub-container and a self-activated oxygen-absorber in a second sub-container.

1 . A pharmaceutical package comprising a bottle that maintains the oxygen content of the air within its interior volume at a reduced level relative to the oxygen content of the ambient air, comprising: 
 A) said bottle,    B) a desiccant disposed within a first sub-container disposed inside said bottle, 
 said first sub-container being adapted to expose said dessicant to the interior of said bottle,  
   C) a self-activated metal-based oxygen-absorber disposed within a second sub-container disposed inside said bottle, 
 said absorber having sufficient oxygen-reducing capacity to reduce and to maintain the interior of said container at an oxygen level less than the oxygen level of the ambient air,  
 said second sub-container having an orifice that exposes said absorber to the interior of said bottle, said orifice having dimensions that allow oxygen scavenging while limiting the diffusion rate of water from said second sub-container such that the interior of said container is maintained at a relative humidity less than 50%.  
   
     
     
         2 . A package as defined in  claim 1 , wherein the metal used in said oxygen absorber is selected from iron, tin, nickel, copper and zinc  
     
     
         3 . A package as defined in  claim 1  or  2 , wherein the cross sectional area of said orifice is between 0.8 and 38×10 −4 cm   2 .  
     
     
         4 . A package as defined in any one of claims  1 - 3 , wherein said orifice is a hole having a diameter between 100 and 700 μM.  
     
     
         5 . A package as defined in any one of claims  1 - 4 , wherein said bottle is fabricated from a polymeric plastic having a thickness such that the oxygen permeability of said bottle is from 3500 cc mil/(m 2 day atm) to 9500 cc mil/(m 2 day atm).  
     
     
         6 . A package as defined in any one of claims  1 - 5 , wherein said sub-containers are physically separate.  
     
     
         7 . A package as defined in any one of claims  1 - 6 , wherein said sub-containers are formed as physically separate compartments of a unitary cartridge.  
     
     
         8 . A package as defined in any one of claims  1 - 7 , further comprising, within said bottle, a third sub-container (D) adapted to contain a quantity of self-activated metal-based oxygen absorber separate from the absorber contained in sub-container (C).  
     
     
         9 . A package as defined in  claim 8 , wherein said sub-container (D) is physically separate from sub-containers (B) and (C).  
     
     
         10 . A package as defined in  claim 8  or  9 , wherein said sub-container (D) is engineered as a compartment in a cartridge also containing, as individual compartments, sub-containers (B) and (C).  
     
     
         11 . A package as defined in any one of claims  1 - 10 , wherein said bottle is fabricated at least in part of a pharmaceutically acceptable polymer.  
     
     
         12 . A package as defined in any one of claims  1 - 11 , wherein said desiccant is silica gel.  
     
     
         13 . A package as defined in any one of claims  1 - 12 , wherein the metal used in said oxygen absorber is iron.  
     
     
         14 . A package as defined in any one of claims  1 - 13 , wherein the orifice of the second sub-container is a hole having a diameter between 200 and 600 μM.