Apparatus for predicting the suitability of a substance for dry granulation by roller compaction using small sample sizes

Abstract

An apparatus for fabricating small compacts of formulations of a drug candidate, and a method for determining if a drug candidate, alone or in a formula mix, is suitable for dry granulation by a roller compactor based on physical measurements generated in part from such small compact.

What is claimed is:  
     
         1 . A press punch for fabricating compacts comprising: 
 an upper guide section defining an aperture for receiving a first tablet punch;    a threaded adjuster operatively coupled to a second tablet punch;    a die; and    a lower guide section defining a passage, said passage having a first profile, for receiving said die, and a second profile, for threadably engaging said threaded adjuster;    wherein the upper guide section and the lower guide section are adapted and configured to cooperate with each other in a manner to sealingly enclose said die.    
     
     
         2 . The press punch as recited in  claim 1 , wherein said second tablet punch is movable with respect to said threaded adjuster.  
     
     
         3 . The press punch as recited in  claim 2 , wherein the threaded adjuster defines an adjuster recess.  
     
     
         4 . The press punch as recited in  claim 3 , further comprising a tablet ejection plug.  
     
     
         5 . The press punch as recited in  claim 4 , wherein the tablet ejection plug is adapted and configured to couple within said adjuster recess.  
     
     
         6 . The press punch as recited in  claim 5 , wherein upon coupling of the ejection plug into the adjuster recess said second tablet punch moves with respect to said threaded adjuster.  
     
     
         7 . An enclosed press punch assembly for creating small compacts from small quantities of material, comprising: 
 an integral guide section having an upper end and a lower end surface, said integral guide section defining a recess;    a die having a top surface and a bottom surface adapted and configured to sealingly fit within a medial portion of said recess of said integral guide section;    a movable upper punch adapted and configured to sealingly fit within said recess of said integral guide section from said upper end surface to said top surface of said die; and    a movable lower punch adapted and configured to sealingly fit within said recess from said lower end surface to said bottom surface of said die.    
     
     
         8 . A press punch for fabricating compacts comprising: 
 an upper guide section defining an aperture for receiving a first tablet punch;    a selectively positionable adjuster operatively coupled to a second tablet punch;    a die; and    a lower guide section defining a passage, said passage having a first profile, for receiving said die, and a second profile, for engaging said selectively positionable adjuster    wherein the upper guide section and the lower guide section are adapted and configured to cooperate with each other in a manner to sealingly enclose said die.    
     
     
         9 . The press punch as recited in  claim 8 , wherein said second tablet punch is movable with respect to said selectively positioned adjuster.  
     
     
         10 . The press punch as recited in  claim 9 , wherein the selectively positioned adjuster defines an adjuster recess.  
     
     
         11 . The press punch as recited in  claim 10 , further comprising a tablet ejection plug.  
     
     
         12 . The press punch as recited in  claim 11 , wherein the tablet ejection plug is adapted and configured to couple within said adjuster recess.  
     
     
         13 . The press punch as recited in  claim 12 , wherein upon -coupling of the ejection plug into the adjuster recess, said second tablet punch moves with respect to said selectively positionable adjuster.