Hot-melt extruded pharmaceutical dosage form

1. A hot-melt extruded tablet having a front side and an opposite back side, the tablet comprising:

(i) a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C);

(ii) an oblong shape imparted by post-hot-melt-extrusion pressing of a hot-melt extrudate on a tablet-press; and

(iii) a circumferential rim between the front and back sides;

wherein the tablet exhibits a breaking strength of at least 300 N;

wherein the tablet exhibits controlled release of the pharmacologically active ingredient (A);

wherein the tablet comprises a direction of extrusion that runs parallel to a direction of extrusion of the hot-melt extrudate through an extrusion die;

wherein the tablet comprises a longitudinal direction of extension, which longitudinal direction of extension is the longest dimension of the tablet and runs orthogonal to the direction of extrusion;

wherein the tablet comprises a transversal direction of extension orthogonal to the longitudinal direction of extension and orthogonal to the direction of extrusion;

wherein the oblong shape is imparted by post-extrusion pressing of the extrudate on the tablet-press in a pressing direction parallel to said direction of extrusion and orthogonal to both said longitudinal direction of extension and said transversal direction of extension; and

wherein the tablet has a core having a morphological orientation caused by the hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the tablet.

2. The tablet according to claim 1 , wherein the pharmacologically active ingredient (A) is an opioid.

3. The tablet according to claim 1 , wherein polymer (C) is a polyalkylene oxide having a weight average molecular weight of at least 200,000 g/mol.

4. The tablet according to claim 1 , wherein the content of polymer (C) is at least 30 wt.-%, based on the total weight of the tablet.

5. The tablet according to claim 1 , wherein the relative length ratio of the longitudinal direction of extension to the transversal direction of extension is at least 1.1:1.

6. The tablet according to claim 1 , further comprising a film coating.

7. The tablet according to claim 1 , which releases the pharmacologically active ingredient (A) under in vitro conditions in artificial gastric juice according to the following release profile:

after 0.5 h at least 5 wt.-%,

after 1 h at least 10 wt.-%,

after 3 h at least 20 wt.-%,

after 6 h at least 35 wt.-%, and

after 12 h at least 55 wt.-%,

based on the total weight of the pharmacologically active ingredient (A) initially contained in the tablet.

8. A process for the manufacture of a hot-melt extruded pharmaceutical tablet according to claim 1 , said process comprising the steps of:

(a) hot-melt extruding a mass comprising:

the pharmacologically active ingredient (A), and

the polymer (C),

through an oblong die thereby obtaining an extrudate with an oblong cross-section;

(b) cutting said extrudate into slices having two opposing cut surfaces of oblong shape;

(c) placing said slices into a tabletting tool comprising an upper punch and a lower punch in a manner so that the two opposing cut surfaces of oblong shape face said upper and lower punch, respectively;

(d) press-forming tablets from the slices; and

(e) optionally, applying a film coating.

9. The process according to claim 8 , wherein step (a) is performed by means of a twin-screw-extruder.

10. The process of claim 8 , wherein at least 50% of the total surface of the slices obtained in step (b) is formed by the two opposing cut surfaces.

11. The process of claim 9 , wherein at least 50% of the total surface of the slices obtained in step (b) is formed by the two opposing cut surfaces.

12. The tablet according to claim 1 comprising a monolithic core.

13. The tablet according to claim 1 , which exhibits a release per unit area of the pharmacologically active ingredient (A) through the front side and the opposite back side that is faster than the release through the circumferential rim.

14. A hot-melt extruded tablet having a front side and an opposite back side, the tablet comprising:

(i) a pharmacologically active ingredient (A) in a matrix comprising a polymer (C);

(ii) an oblong shape imparted by post-hot-melt-extrusion pressing of a hot-melt extrudate on a tablet-press; and

(iii) a circumferential rim between the front and back sides;

wherein the tablet exhibits a breaking strength of at least 300 N;

wherein the tablet exhibits controlled release of the pharmacologically active ingredient (A);

wherein the tablet has a direction of extrusion that runs parallel to a direction of extrusion of said hot-melt extrudate through an extrusion die;

wherein the tablet has a longitudinal direction of extension, which is the longest dimension in the tablet and runs orthogonal to the direction of extrusion;

wherein the tablet has a transversal direction of extension that runs orthogonal to both the direction of extrusion and the longitudinal direction of extension; and

wherein the oblong shape is imparted by compressing the hot-melt extrudate parallel to the direction of extrusion and orthogonal to the longitudinal direction of extension.