Method for producing monolithic tablets

Abstract

The present invention relates to a process for producing monolithic tablets. The method employs a melt-processed composition containing at least on active agent and at least one thermoplastic binder. The invention further relates to a method for cutting and deflashing a belt of pre-shaped bodies of a melt-processed composition, wherein the pre-shaped bodies are interconnected by flash.

What is claimed is: 
     
         1 . A method for producing a monolithic tablet, the method comprising the steps of:
 a) providing a melt-processed composition containing at least one active agent and at least one thermoplastic binder;   b) charging a predetermined amount by weight of the melt-processed composition into a die cavity;   c) compressing the melt-processed composition to simultaneously shape and deflash the composition to form a monolithic tablet, using compression equipment; and   d) ejecting the monolithic tablet from the die.   
     
     
         2 . The method of  claim 1 , wherein the melt-processed composition is rendered plastically deformable by heating prior to compression. 
     
     
         3 . The method of  claim 1 , wherein providing the melt-processed composition comprises plastifying a composition containing at least one active agent and at least one thermoplastic binder by heating, shearing and heating and shearing to obtain a melt, and forcing the melt through at least one orifice. 
     
     
         4 . The method of  claim 1 , wherein the melt-processed composition is manufactured by melt-extrusion or injection molding. 
     
     
         5 . The method of  claim 1 , comprising providing pre-shaped bodies of the melt-processed composition, wherein each pre-shaped body has a predetermined weight, and charging a pre-determined number of the pre-shaped bodies into the die cavity. 
     
     
         6 . The method of  claim 5 , wherein the number of pre-shaped bodies to be charged into the die cavity is one. 
     
     
         7 . The method of  claim 5 , wherein providing pre-shaped bodies of the melt-processed mixture comprises a calendering process. 
     
     
         8 . The method of  claim 5 , wherein providing pre-shaped bodies of the melt-processed mixture comprises a calendering process to obtain a belt of pre-shaped bodies, the pre-shaped bodies being interconnected by flash; followed by cutting of the belt into individual pre-shaped bodies or strips of pre-shaped bodies prior to charging the pre-shaped bodies into the die cavity. 
     
     
         9 . The method of  claim 1 , comprising providing a belt of pre-shaped bodies of the melt-processed mixture each having an predetermined weight, the pre-shaped bodies being interconnected by flash, cutting out a pre-shaped body from the belt and charging the pre-shaped body into the die cavity. 
     
     
         10 . The method of  claim 9 , wherein the cutting and charging action is synchronized with the advancing action of the compression equipment. 
     
     
         11 . The method of  claim 9 , wherein providing the belt of pre-shaped bodies of the melt-processed composition comprises a calendering process. 
     
     
         12 . The method of  claim 9 , wherein the belt of pre-shaped bodies of the melt-processed composition is unwound from a spool. 
     
     
         13 . The method of  claim 9 , wherein the belt comprises a single row of pre-shaped bodies of the melt-processed composition. 
     
     
         14 . The method of  claim 9 , wherein the belt comprises more than one row of pre-shaped bodies of the melt-processed composition. 
     
     
         15 . The method of  claim 9 , wherein the belt is cut into a plurality of single-row belts. 
     
     
         16 . The method of  claim 9 , wherein deflashing of the pre-shaped body occurs through plastic deformation during shaping. 
     
     
         17 . A method for producing monolithic tablets, the method comprising the steps of:
 a) providing a belt of pre-shaped bodies of a melt-processed composition, the pre-shaped bodies in said belt being interconnected by flash, each pre-shaped body having an predetermined weight;   b) cutting the interconnecting flash in the belt to obtain singulated pre-shaped bodies; and   c) compressing the singulated pre-shaped bodies to shape and deflash to obtain monolithic tablets.   
     
     
         18 . The method of  claim 17 , wherein cutting and deflashing are performed sequentially. 
     
     
         19 . The method of  claim 17 , wherein cutting and deflashing are performed simultaneously. 
     
     
         20 . The method of  claim 9 , wherein the cutting and calendaring is synchronized with the advancing action of the compression equipment. 
     
     
         21 . The method of  claim 5  or  17  wherein the pre-shaped bodies are a cylinder with hemispherical extremities.