METHOD FOR PRODUCING MONOLITHIC TABLETS

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.