Blister package for topiramate tablets

Abstract

The present invention provides a blister package for topiramate tablets comprising a pan sheet having preformed cavities containing topiramate tablets dried to a free water content of between about 0.4% to about 1.4% and a cover sheet sealed to the pan sheet. The present invention further provides a process for blister packaging dried topiramate tablets into a blister package with improved shelf-life and stability performance.

1 . A blister package for topiramate tablets comprising a pan sheet having preformed cavities containing topiramate tablets, and a cover sheet sealed to the pan sheet; wherein the topiramate tablets have a free water content of between about 0.4% to about 1.4% at the time the cover sheet is sealed to the pan sheet and wherein the blister package thus formed contains no desiccant.  
     
     
         2 . The blister package of  claim 1  wherein the pan sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a single plastic layer, multiple plastic layers, and a composite metal and plastic layer.  
     
     
         3 . The blister package of  claim 2  wherein the cover sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a composite metal and plastic layer, a composite metal and paper layer, and a composite metal, plastic and paper layer.  
     
     
         4 . The blister package of  claim 3 , wherein the pan sheet is a composite metal and plastic layer and the cover sheet is a metal layer.  
     
     
         5 . The blister package of  claim 4  wherein the pan sheet is a composite metal and plastic layer of ortho-polyamide/aluminum foil/polyvinylchloride and the cover sheet is a single aluminum foil layer.  
     
     
         6 . The blister package of  claim 5  wherein the pan sheet is a 25 μm ortho-polyamide/45 μm aluminum foil/60 μm polyvinylchloride sheet and the cover sheet is a 20 μm aluminum foil sheet.  
     
     
         7 . The blister package of  claim 1  wherein the topiramate tablets have between about 0.7% to about 1.2% free water.  
     
     
         8 . The blister package of  claim 7  wherein the topiramate tablets have between about 0.8% to about 1.0% free water.  
     
     
         9 . The blister package of  claim 1  wherein the topiramate tablets are dried by a method selected from the group consisting of microwave drying, vacuum drying, hot air drying, infrared drying, drying using very dry air either statically or dynamically, and drying by placing a desiccant in a storage drum of bulk product for a period of time.  
     
     
         10 . The blister package of claim  0  wherein the topiramate tablets are dried using hot air.  
     
     
         11 . A process for making a blister package containing topiramate tablets comprising the steps of: 
 (a) drying a plurality of topiramate tablets to a free water content of between about 0.4% to about 1.4%;    (b) placing the dried topiramate tablets from step (a) into a pan sheet having a plurality of cavities; and    (c) sealing a cover sheet to the pan sheet from step (b) to form the blister package, provided that the dried topiramate tablets have a free water content of less than about 1.4% at the time the cover sheet is sealed to the pan sheet and wherein the blister package contains no desiccant.    
     
     
         12 . The process of  claim 11  wherein the pan sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a single plastic layer, multiple plastic layers and a composite metal and plastic layer.  
     
     
         13 . The process of  claim 12  wherein the cover sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a composite metal and plastic layer, a composite metal, and paper layer and a composite metal, plastic and paper layer.  
     
     
         14 . The process of  claim 13 , wherein the pan sheet is a composite metal and plastic layer and the cover sheet is a metal layer.  
     
     
         15 . The process of  claim 14  wherein the pan sheet is a composite metal and plastic layer of ortho-polyamide/aluminum foil/polyvinylchloride and the cover sheet is a single aluminum foil layer.  
     
     
         16 . The process of  claim 15  wherein the pan sheet is a 25 μm ortho-polyamide/45 μm aluminum foil/60 μm polyvinylchloride sheet and the cover sheet is a 20 μm aluminum foil sheet.  
     
     
         17 . The process of  claim 11  wherein the topiramate tablets are dried to a free water content of between about 0.7% to about 1.2%.  
     
     
         18 . The process of  claim 17  wherein the topiramate tablets are dried to a free water content of between about 0.8% to about 1.0%.  
     
     
         19 . The process of  claim 11  wherein the topiramate tablets are dried by a method selected from the group consisting of microwave drying, vacuum drying, hot air drying, infrared drying, drying using very dry air either statically or dynamically, and drying by placing a desiccant in a storage drum of bulk product for a period of time.  
     
     
         20 . The process of  claim 19  wherein the topiramate tablets are dried using hot air in a coater at a temperature from about 60° C. to about 70° C.  
     
     
         21 . A blister package made by the process of  claim 11.