Vessel, method and apparatus for dissolution testing of an annular pharmaceutical delivery device

Abstract

The invention relates to a vessel for dissolution testing of a pharmaceutical delivery device, comprising: an inert vessel wall and an inert vessel bottom such that the vessel is able to hold a fluid medium; an inert retainer provided by or at the vessel wall or vessel bottom, for holding a pharmaceutical delivery device; and which retainer allows a passageway to the vessel bottom for a sampling tube. The invention further relates to a method for preparing such a vessel; a dissolution method using such a vessel and an apparatus comprising such a vessel.

1 - 11 . (canceled)  
     
     
         12 . A vessel for dissolution testing of an annular pharmaceutical delivery device, comprising: 
 an inert vessel wall and an inert vessel bottom such that the vessel is able to hold a fluid medium; and    an inert retainer provided by or at the vessel wall or vessel bottom, for holding the annular pharmaceutical delivery device and providing a passageway to the vessel bottom for a sampling tube.    
     
     
         13 . The vessel according to  claim 12 , wherein the vessel wall and the vessel bottom together form one transparent glass entity.  
     
     
         14 . The vessel according to  claim 12 , wherein the retainer comprises an annular plate, which annular plate comprises the passageway for the sampling tube in the middle of the annular plate, and the annular plate is placed inside the vessel at the vessel wall.  
     
     
         15 . The vessel according to  claim 12 , wherein the retainer is permanently fixed to the vessel wall or the vessel bottom.  
     
     
         16 . The vessel according to  claim 12 , wherein the retainer is selected from the group consisting of one or more annular ledges protruding inwardly from the vessel wall or vessel bottom, one or more annular rims protruding inwardly from the vessel wall or vessel bottom, and one or more bulges protruding inwardly from the vessel wall or vessel bottom.  
     
     
         17 . The vessel according to  claim 16 , wherein the retainer comprises two sets of bulges formed by indentation of the vessel wall or vessel bottom.  
     
     
         18 . A method for preparing the vessel according to  claim 15 , comprising melting or gluing the retainer to the vessel wall or vessel bottom.  
     
     
         19 . An apparatus for dissolution testing of a pharmaceutical delivery device, comprising: 
 one or more dissolution vessels according to  claim 12 ,    one or more stirring means; and    a sampling and/or discharging device with one or more sampling and/or discharging tubes suitable for sampling and/or discharging one or more predetermined volume fractions of the fluid medium from the dissolution vessels.    
     
     
         20 . The apparatus of  claim 19 , further comprising a refilling device suitable for adding fluid medium to the dissolution vessels.